- Email: [email protected]
EyePrintPRO therapeutic scleral contact lens: indications and outcomes
EyePrintPRO therapeutic scleral contact lens: indications and outcomes Michael T.B. Nguyen,* Vishakha Thakrar, OD, FAAO, FSLS,†,‡ Clara C. Chan, MD, FRCSC, FACS‡,§ ABSTRACT ● Objective: To describe indications and outcomes of patients fitted with the EyePrintPRO therapeutic scleral lens. Methods: A database search of patients fitted with the EyePrintPRO from 2014 to 2016. Fourteen eyes of 10 patients were reviewed retrospectively. Patient demographics, medical and ocular history, indications for fitting, duration of wear, symptoms, and bestcorrected visual acuity (BCVA) were analyzed. Results: Mean age at lens fitting was 49 years (range, 21–67 years). The average duration of wear was 12 months (range, 7–17 months). Indications for fitting included limbal stem cell deficiency, post–photorefractive keratectomy (PRK) decentred ablation, pellucid marginal degeneration, Stevens-Johnson syndrome, keratoconus, dry eye, neurotrophic keratitis, exposure keratitis from facial nerve paralysis, and post–radial keratotomy (RK) symptoms. Mean BCVA was 20/36 (range, 20/20–20/200). After the fitting, mean BCVA was 20/21 (range 20/10–20/60, p ¼ 0.001). Nine patients reported resolution of their blurry vision, and all reported improvement of dry eye, eye redness, and pain symptoms. Six of 7 previous lens wearers reported significantly greater comfort with EyePrintPRO wear and the ability to wear the lens throughout the day; only 2 experienced fogging and needed to clean the lens after 4–6 hours of wear. Conclusions: A variety of indications for the EyePrintPRO scleral lens exist, and patients experience resolution of major symptoms. The ophthalmologist should be aware that therapeutic scleral lenses, including the EyePrintPRO, exist for patients for whom there is no surgical intervention or who want to delay or obviate the need for surgery.
There has been a resurgence of interest in scleral lenses over the past decade, especially in the management of ectatic corneal disorders and severe ocular surface disease (e.g., Stevens-Johnson syndrome, graft-versus-host disease, and ocular cicatricial pemphigoid). Scleral lenses are largediameter, gas-permeable lenses that vault over the cornea and rest on the sclera. The Scleral Lens Education Society has recommended internationally recognized nomenclature for describing scleral lenses according to their bearing, summarized in Table 1. By avoiding direct corneal contact, scleral lenses may be more suitable for patients who are unable to tolerate conventional corneal contact lenses. In addition, scleral lenses feature a constant tear reservoir between the cornea and the posterior surface of the lens, which hydrates the corneal surface, prevents tear film evaporation, and helps neutralize corneal aberrations.1,2 Several reports also show the potential of scleral lenses in delaying or preventing the need for penetrating keratoplasty or limbal stem cell transplant surgery.3–5 At present, the most commonly used method of scleral lens fitting involves the use of trial sets of prefabricated lenses with varying vaults, base curve radii, power, and diameters.6 Based on these parameters, scleral lenses can be quickly and precisely produced using computerized lathes.7 Many parameters of the lenses can be customized, but there are limitations to fitting conventional scleral
lenses when the sclera and peripheral cornea are highly irregular in shape. The EyePrintPRO (Advanced Vision Technologies, Lakewood, Colo.) is a new large-scleral lens that can precisely fit scleral and corneal irregularities. First, a polyvinyl siloxane material is used to create an impression mold over the ocular surface. The mold is then scanned with a 3D scanner. Finally, the posterior surface of the lens is created with lathe technology to the specific contours of the globe based on any irregularity of the cornea or sclera (Fig. 1). The result is a highly oxygen-transmissible scleral lens that is customized to the anterior surface of the eye (Fig. 2). The lenses are made from Optimum GP materials (Contamac, Grand Junction, Colo.) and surface treated with Hydra-PEG technology to improve lens wettability and patient comfort. The precision of the design allows for improved fitting characteristics over the cornea and sclera. Although indications and outcomes for therapeutic scleral lens systems such as the Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) device and others have been described,3,4,8–11 there are currently no published reports describing the indications and outcomes for the EyePrintPRO scleral lens (no references were found in a computerized search in the PubMed database). This study aims to describe the different indications and outcomes of patients fitted with the EyePrintPRO.
& 2017 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcjo.2017.07.026 ISSN 0008-4182/17 CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
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EyePrintPRO therapeutic scleral contact lens—Nguyen et al. Table 1—International recognized nomenclature for describing scleral lenses according to size and fit characteristics
RESULTS
This retrospective, observational case series was approved by the Research Ethics Board of the University of Toronto, Ont. (Protocol ID No. 32955). This study was conducted in compliance with the tenets of the Declaration of Helsinki. A database search of patients who had undergone EyePrintPRO fittings was conducted from an optometrist’s clinical practice at the Vaughan Family Vision Care, Vaughan, Ont. The charts of 14 eyes from 10 patients fitted with the EyePrintPRO between 2014 and 2016 were retrospectively reviewed. Patient demographics, medical and ocular history, indications for EyePrintPRO fitting, duration of lens wear, symptoms, and best-corrected visual acuity (BCVA)—before and after fitting of the EyePrintPRO scleral lens—were analyzed. Visual acuities were recorded in Snellen and converted to logMAR for statistical analysis. The significance of the difference between pre- and post-EyePrintPRO wear was assessed by the paired t test; p o 0.05 was considered statistically significant.
Individual patient and ocular details are shown in Table 2. The average age at the time of EyePrintPRO fitting was 49 years (SD 15; range, 21–67 years). The average length of EyePrintPRO wear was 12 months (SD 4; range, 7–17 months). Indications for fitting of the EyePrintPRO included limbal stem cell deficiency, post–photorefractive keratectomy (PRK) decentred ablation, pellucid marginal degeneration, Stevens-Johnson syndrome, keratoconus, dry eye, neurotrophic keratitis, exposure keratitis from facial nerve paralysis, and post– radial keratotomy (RK) symptoms. The majority of patient eyes (8/14) had failed either corneal contact lens or conventional scleral lens wear because of inadequate comfort, vision, or a compromise to the cornea and ocular surface. All patient eyes (14/14) presented with blurry vision. Dry eye was also common in 10 (71%) of the 14 eyes, followed by discomfort in 7 (50%) of the 14 eyes, redness in 7 (50%) of the 14 eyes, and pain in 6 (43%) of the 14 eyes. Mean best-corrected logMAR visual acuity before EyePrintPRO fitting was 0.430 (Snellen 20/54; range, 20/ 20–20/200). After EyePrintPRO fitting, mean logMAR visual acuity was 0.03 (Snellen 20/21; range 20/10–20/60, p ¼ 0.001). Thirteen (93%) of the 14 eyes experienced a visual improvement, and all patients reported satisfaction with the scleral lens. Seven (88%) of the 8 eyes that were previous lens wearers before the EyePrintPRO experienced greater comfort and ability to wear the device for a longer period during the day. Most eyes (93%) experienced resolution of blurry vision, and all eyes experienced improvement of their symptoms of dry eye, redness, and/or pain. Two eyes (14%) experienced fogging and needed to clean the lens after 4–6 hours of wear.
Fig. 1 — Computerized 3D image of the mold taken of the eye of patient 10. Green overlay indicates the shape of the EyePrintPRO scleral lens to be lathed. The gray circle demonstrates the limbus. The back surface of the lens shows clearance over the cornea and limbus and lands on the sclera. (Photo courtesy of Advanced Vision Technologies.)
Fig. 2 — Computerized 3D image of the mold taken of the eye of patient 9. The patient’s eye has irregular pinguecula and conjunctival chalasis present on both the nasal and temporal side. The EyePrintPRO was successfully fitted on this patient’s eye. (Photo courtesy of Advanced Vision Technologies.)
Lens Type
Bearing
Corneal
Lens rests entirely on the cornea.
Corneo-scleral
Lens rests partly on the cornea, partly on the sclera.
Scleral A. Mini-scleral: lens is up to 6 mm larger than HVID. B. Large-scleral: lens is more than 6 mm larger than HVID.
Lens rests entirely on the sclera.
HVID, horizontal visible iris diameter.
METHODS
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CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
EyePrintPRO therapeutic scleral contact lens—Nguyen et al. Table 2—Clinical characteristics of patients fitted with the EyePrintPRO scleral lens
Case No.
Pt Age, No. y Sex
Disease
BCVA Without Contact Lens
Daily Lens Wear (h)
BCVA with Other Scleral/ BCVA with Eye Corneal Lens EyePrintPRO
1
1
27
F
Limbal stem cell deficiency
20/200
8
R
20/30
20/25
2 3
2 2
52 52
M M
Post-PRK Post-PRK
20/20 20/200
8 8
R L
20/20 20/40
20/10 20/20
4
3
54
M
N/A
16
L
20/25
20/20
5
4
21
M
Pellucid marginal degeneration Stevens-Johnson syndrome þ limbal stem cell deficiency
N/A
16
L
20/60
20/30
6 7
5 5
38 38
M M
Keratoconus Keratoconus
20/60 20/20
10 10
R L
N/A N/A
20/25 20/20
8 9
6 6
57 57
F F
Dry eye Dry eye
20/20 20/20
16 16
R L
N/A N/A
20/20 20/20
10
7
59
M
20/60
14
R
N/A
20/25
11
7
59
M
20/25
14
L
N/A
20/20
12
8
67
M
20/200
16
R
20/70
20/30
13
9
57
M
Neurotrophic keratitis Neurotrophic keratitis Facial nerve paralysis Post-PK
N/A
16
R
20/25
20/20
14
10
54
M
Post-RK
N/A
5
L
20/40
20/25
Additional Notes Pt had scleral irregularities and conjunctival breaks causing pain and impingement with previous scleral lens. Superficial punctate keratopathy resolved with EyePrintPRO wear. Pt had decentred ablation with secondary corneal scarring OS 4 OD. Scleral lens fitting was unsuccessful at multiple centres throughout the United States because of fogging and dissatisfaction in vision. Pt had discomfort and hyperemia with previous scleral lens wear. Pt had reduction in vision and severe conjunctival chemosis and hyperemia with habitual scleral lens. Pt’s conjunctivalization over corneal surface remained stable over follow-up period. Pt unsuccessfully sought comfort from corneal and scleral lenses over a 15-year period before EyePrintPRO. Pt had exhausted all other treatments for chronic Meibomian gland dysfunction and lagophthalmos. Her sclera was highly irregular, making traditional scleral lens fitting challenging before EyePrintPRO. Pt had a large conjunctival cyst that the EyePrintPRO was successfully able to fit over.
Facial nerve paralysis limited the patient’s blink reflex, which lead to fogging of past scleral lens wear. Pt had a protruding graft that was more elevated in the peripheral cornea, making traditional scleral lens fitting challenging before EyePrintPRO. Pt had a pingueculum and raised peripheral cornea and was not able to wear traditional scleral lenses without hyperemia.
Pt, patient; BCVA, best-corrected visual acuity; PK, penetrating keratoplasty; PRK, photorefractive keratectomy; RK, radial keratotomy.
DISCUSSION
This novel series of 14 eyes of 10 patients fitted with the EyePrintPRO demonstrates that the EyePrintPRO can successfully treat a variety of eye diseases, including limbal stem cell deficiency, post-PRK decentred ablation, pellucid marginal degeneration, Stevens-Johnson syndrome, keratoconus, dry eye, neurotrophic keratitis, exposure keratitis from facial nerve paralysis, and post-RK symptoms. Many of these diseases have limited treatment options, such as deep anterior lamellar keratoplasty or penetrating keratoplasty, but these would incur intraoperative and rejection risks and would require the patient to be on long-term steroids.12 Scleral lens therapy has been reported to treat patients with limbal stem cell deficiency and possibly delay the need for limbal stem cell transplantation, keratoprosthesis implantation, or penetrating keratoplasty.13 Our patient with limbal stem cell deficiency (case 1) had failed with multiple attempts at conventional scleral lenses because the sclera was highly irregular and resulted in impingement (excess conjunctival pressure). The EyePrintPRO was able to gently land over the irregular regions of the sclera while still vaulting the cornea for a more comfortable fit. A study by Schornack reported the ability of a scleral lens to successfully treat a patient with progressively
worsening limbal stem cell deficiency, delaying the need for limbal stem cell transplantation and associated systemic immunosuppression.14 Similar scleral irregularities, such as a conjunctival cyst (case 10), large pingueculum (case 14), and a highly asymmetric sclera (cases 8 and 9), also presented challenges in the fitting of conventional spherical and toric scleral lenses before being fitted with the EyePrintPRO scleral lens. Patients with severe ocular surface disease such as Stevens-Johnson syndrome, neurotrophic keratitis, and facial nerve paralysis often can exhaust traditional dry eye interventions and the limited surgical treatments that are available to them, except for tarsorrhaphy, which is not ideal functionally or cosmetically. In fact, in our series, a patient with facial nerve paralysis (case 12) had a partial tarsorrhaphy but still presented with severe exposure keratitis. Interestingly, his previous conventional scleral lens produced high anterior surface fogging, whereas the EyePrintPRO did not. Use of the lens reduced the epitheliopathy and improved his vision to 20/30. Furthermore, his epitheliopathy was reduced from grade 4 confluent to trace epitheliopathy. This patient was able to better tolerate the EyePrintPRO than other scleral lenses for 2 reasons: (i) the fit was more precise, and (ii) the EyePrintPRO was treated with Hydra-PEG CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
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EyePrintPRO therapeutic scleral contact lens—Nguyen et al. technology, a coating that improves wettability, increases lens surface water retention, and minimizes lens fogging. This enabled him to wear the EyePrintPRO for longer periods without blurred vision, and he applied less artificial tears as a result.15 In 2013, Weyns et al. reported that scleral contact lenses were a valid treatment alternative to tarsorrhaphy for patients with facial nerve paralysis, even 18 years after the original lens fitting.16 Our current study shows that the EyePrintPRO has been successfully fitted in patients with these ocular surface diseases and can offer an additional treatment option for patients who have ocular surface disease refractory to other treatments or conditions for which surgical intervention is not ideal. Our study demonstrated that BCVA of 20/30 or better was achieved in all 14 of the patient eyes. This finding is consistent with previous reports.17 Furthermore, all patients in our study reported improvement of dry eye, redness, or pain symptoms. Almost all (93%) of the patients experienced resolution of their blurry vision and were extremely satisfied with the results. A recent literature review suggests that subjective patient satisfaction was actually the best indicator of performance of scleral contact lenses from the patients’ standpoint.6 Most patients referred for treatment in this study had failed previous attempts at contact lens rehabilitation of their vision, and many had also failed further treatment with advanced modalities such as specialty contact lenses, soft and corneal rigid gas-permeable contact lenses, piggyback systems, and hybrid and conventional scleral lenses. All patients reported increased satisfaction with the EyePrintPRO compared with past failed treatment modalities. The reason for this is likely the process by which the EyePrintPRO is customized to each patient case. There has been a long history of comfort and visual and therapeutic benefits of scleral contact lenses; however, the fitting process of the EyePrintPRO makes it unique. Instead of requiring a series of standardized curvatures as with conventional scleral lenses, the mold used to configure the EyePrintPRO is generated to match the unique irregularities of the individual eye. Thus, the EyePrintPRO is a completely custom scleral lens that matches the exact contours of the anterior surface of the globe. The importance of this is evident when looking at the indications for use of the lens, most of which are characterized by extreme ocular surface irregularities. Common complications of scleral lens wear, including bulbar redness, conjunctival blanching or impingement, and scleral lens adhesion, were reduced or eliminated in this case series. Widespread adoption of conventional scleral lenses has been limited because of the steep learning curve, the timeintensive fitting process, and the reliance on the expertise of the lens-fitting specialist.6 With the EyePrintPRO, the efficient impression mold technique is a simplified approach that could reduce interpractitioner variability in the fitting of the lenses. The development of the EyePrintPRO scleral lens provides an additional
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CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
option among the wide range of currently available scleral lenses. There are some limitations of the EyePrintPRO scleral lens. The applicator device used to make the mold is 26 mm in diameter. If a patient has a narrow interpalpebral fissure or irregularities of the conjunctiva, such as symblephara or adhesions, it may be challenging to insert the applicator device. In many cases, smaller custom applicators need to be ordered. Additional limitations are similar to other scleral lenses in general. Scleral lenses limit tear turnover under the lens, leading to tear stagnation.18 Tear stagnation can result in decreased visual acuity and may increase the chance of microbial keratitis.6 We did not find a similar drop in visual acuity, but 2 (14%) of the 14 eyes experienced discomfort and fogging. These symptoms resolved after the patients removed their lens once or twice a day to clean them with fresh saline. There were no adverse events of infectious keratitis in our series. This study is limited by its retrospective nature. However, it is the first series in the literature to present the indications and outcomes of a heterogeneous patient population that has been fitted with the EyePrintPRO scleral lens. The preliminary results in this study illustrate that this device is effective and could have a place in the treatment algorithm for these complex patients. No complications related to the use of the EyePrintPRO (corneal opacifications or infections) were identified in this study, but longer follow-up is required. Future studies could include a comfort grading scale to help provide more objective measures of improvement; a validated dry eye survey such as the Ocular Surface Disease Index could be used to assess symptoms; and a patient quality-of-life questionnaire could also be incorporated. In summary, this study is the first series in the literature to report on the variety of indications for the EyePrintPRO, a scleral lens that uses a mold technology with 3D scanning to create a truly customized fit for patients with scleral and corneal irregularities. Patient outcomes in our series were positive. The comprehensive ophthalmologist should be aware that this new therapeutic scleral lens exists as an addition to the armamentarium of options for patients who have failed other lenses, have severe ocular surface disease, or have conditions in which surgical intervention is best to be delayed or obviated. REFERENCES 1. Romero-Rangel T, Stavrou P, Cotter J, et al. Gas-permeable scleral contact lens therapy in ocular surface disease. Am J Ophthalmol. 2000;130:25-32. 2. Pecego M, Barnett M, Mannis MJ, et al. Jupiter scleral lenses: the UC Davis Eye Center experience. Eye Cont Lens. 2012;38:179-82. 3. Deloss KS, Nadeem HF, Hood CT. Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) scleral device compared to keratoplasty for the treatment of corneal ectasia. Am J Ophthalmol. 2014;158:974-82. 4. Heur M, Bach D, Theophanous C, et al. Prosthetic replacement of the ocular surface ecosystem scleral lens therapy for patients with
EyePrintPRO therapeutic scleral contact lens—Nguyen et al.
5.
6. 7. 8. 9.
10. 11. 12. 13. 14. 15.
16.
ocular symptoms of chronic Stevens-Johnson syndrome. Am J Ophthalmol. 2014;158:49-54. Rosenthal P, Croteau A. Fluid-ventilated, gas-permeable scleral contact lens is an effective option for managing severe ocular surface disease and many corneal disorders that would otherwise require penetrating keratoplasty. Eye Cont Lens. 2005;31:130-4. van der Worp E, Bornman D, Ferreira DL, et al. Modern scleral contact lenses: a review. Cont Lens Ant Eye. 2014;37:240-50. Rathi VM, Mandathara PS, Taneja M, et al. Scleral lens for keratoconus: technology update. Clin Ophthalmol. 2015;9:2013-8. Stason WB, Razavi M, Jacobs DS, et al. Clinical benefits of the Boston ocular surface prosthesis. Am J Ophthalmol. 2010;149:54-61. Theophanous C, Irvine JA, Parker P, et al. Use of prosthetic replacement of the ocular surface ecosystem scleral lenses in patients with ocular chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2015;21:2180-4. Ling JD, Gire A, Pflugfelder SC. PROSE therapy used to minimize corneal trauma in patients with corneal epithelial defects. Am J Ophthalmol. 2013;155:615-9. Samini DB, Chiu GB, Burnstine MA. PROSE scleral lens: a novel aid for staged eyelid reconstruction. Ophthal Plast Reconstr Surg. 2014;30:119-21. Patel SV, Hodge DO, Bourne WM. Corneal endothelium and postoperative outcomes 15 years after penetrating keratoplasty. Am J Ophthalmol. 2005;139:311-9. Sejpal K, Yu F, Aldave AJ. The Boston keratoprosthesis in the management of corneal limbal stem cell deficiency. Cornea. 2011;30:1187-94. Schornack MM. Limbal stem cell disease: management with scleral lenses. Clin Exp Optom. 2011;94:592-4. Sindt CW. Tangible™ Hydra-PEG: a novel custom contact lens coating technology designed to improve patient comfort and satisfaction (white paper) 2016 Retrieved July 19, 2017, from 〈http://docs.wixstatic.com/ugd/dd2daf_6d730c1482f6450396c734 d74c3017b6.pdf〉. Weyns M, Koppen C, Tassignon MJ. Scleral contact lenses as an alternative to tarsorrhaphy for the long-term management of
combined exposure and neurotrophic keratopathy. Cornea. 2013;32: 359-61. 17. Pullum KW, Whiting MA, Buckley RJ. Scleral contact lenses: the expanding role. Cornea. 2005;24:269-77. 18. Ko L, Maurice D, Ruben M. Fluid exchange under scleral contact lenses in relation to wearing time. Br J Ophthalmol. 1970;54: 486-9.
Footnotes and Disclosure: Clara C. Chan has received honoraria from Alcon Labs Inc (Fort Worth, TX), Allergan (Parsippany, NJ), Bausch & Lomb (Rochester, NY), and Tearscience (Morrisville, NC). Vishakha Thakrar has received honoraria from Johnson & Johnson Vision Care (Jacksonville, FL), Alcon Labs Inc (Fort Worth, TX), Allergan (Parsippany, NJ), and Blanchard Contact Lens Inc (Manchester, NH). Michael T.B. Nguyen has no financial disclosures. From the *Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ont; †Vaughan Family Vision Care, Vaughan, Ont; ‡Kensington Eye Institute, Toronto, Ont; § Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont. Originally received Jan. 21, 2017. Final revision Jul. 21, 2017. Accepted Jul. 26, 2017. Correspondence to Clara C. Chan, MD, Department of Ophthalmology and Vision Sciences, University of Toronto, 600 Sherbourne Street, Suite 601, Toronto, Ont. M4X1W4; [email protected]
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There has been a resurgence of interest in scleral lenses over the past decade, especially in the management of ectatic corneal disorders and severe ocular surface disease (e.g., Stevens-Johnson syndrome, graft-versus-host disease, and ocular cicatricial pemphigoid). Scleral lenses are largediameter, gas-permeable lenses that vault over the cornea and rest on the sclera. The Scleral Lens Education Society has recommended internationally recognized nomenclature for describing scleral lenses according to their bearing, summarized in Table 1. By avoiding direct corneal contact, scleral lenses may be more suitable for patients who are unable to tolerate conventional corneal contact lenses. In addition, scleral lenses feature a constant tear reservoir between the cornea and the posterior surface of the lens, which hydrates the corneal surface, prevents tear film evaporation, and helps neutralize corneal aberrations.1,2 Several reports also show the potential of scleral lenses in delaying or preventing the need for penetrating keratoplasty or limbal stem cell transplant surgery.3–5 At present, the most commonly used method of scleral lens fitting involves the use of trial sets of prefabricated lenses with varying vaults, base curve radii, power, and diameters.6 Based on these parameters, scleral lenses can be quickly and precisely produced using computerized lathes.7 Many parameters of the lenses can be customized, but there are limitations to fitting conventional scleral
lenses when the sclera and peripheral cornea are highly irregular in shape. The EyePrintPRO (Advanced Vision Technologies, Lakewood, Colo.) is a new large-scleral lens that can precisely fit scleral and corneal irregularities. First, a polyvinyl siloxane material is used to create an impression mold over the ocular surface. The mold is then scanned with a 3D scanner. Finally, the posterior surface of the lens is created with lathe technology to the specific contours of the globe based on any irregularity of the cornea or sclera (Fig. 1). The result is a highly oxygen-transmissible scleral lens that is customized to the anterior surface of the eye (Fig. 2). The lenses are made from Optimum GP materials (Contamac, Grand Junction, Colo.) and surface treated with Hydra-PEG technology to improve lens wettability and patient comfort. The precision of the design allows for improved fitting characteristics over the cornea and sclera. Although indications and outcomes for therapeutic scleral lens systems such as the Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) device and others have been described,3,4,8–11 there are currently no published reports describing the indications and outcomes for the EyePrintPRO scleral lens (no references were found in a computerized search in the PubMed database). This study aims to describe the different indications and outcomes of patients fitted with the EyePrintPRO.
& 2017 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcjo.2017.07.026 ISSN 0008-4182/17 CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
1
EyePrintPRO therapeutic scleral contact lens—Nguyen et al. Table 1—International recognized nomenclature for describing scleral lenses according to size and fit characteristics
RESULTS
This retrospective, observational case series was approved by the Research Ethics Board of the University of Toronto, Ont. (Protocol ID No. 32955). This study was conducted in compliance with the tenets of the Declaration of Helsinki. A database search of patients who had undergone EyePrintPRO fittings was conducted from an optometrist’s clinical practice at the Vaughan Family Vision Care, Vaughan, Ont. The charts of 14 eyes from 10 patients fitted with the EyePrintPRO between 2014 and 2016 were retrospectively reviewed. Patient demographics, medical and ocular history, indications for EyePrintPRO fitting, duration of lens wear, symptoms, and best-corrected visual acuity (BCVA)—before and after fitting of the EyePrintPRO scleral lens—were analyzed. Visual acuities were recorded in Snellen and converted to logMAR for statistical analysis. The significance of the difference between pre- and post-EyePrintPRO wear was assessed by the paired t test; p o 0.05 was considered statistically significant.
Individual patient and ocular details are shown in Table 2. The average age at the time of EyePrintPRO fitting was 49 years (SD 15; range, 21–67 years). The average length of EyePrintPRO wear was 12 months (SD 4; range, 7–17 months). Indications for fitting of the EyePrintPRO included limbal stem cell deficiency, post–photorefractive keratectomy (PRK) decentred ablation, pellucid marginal degeneration, Stevens-Johnson syndrome, keratoconus, dry eye, neurotrophic keratitis, exposure keratitis from facial nerve paralysis, and post– radial keratotomy (RK) symptoms. The majority of patient eyes (8/14) had failed either corneal contact lens or conventional scleral lens wear because of inadequate comfort, vision, or a compromise to the cornea and ocular surface. All patient eyes (14/14) presented with blurry vision. Dry eye was also common in 10 (71%) of the 14 eyes, followed by discomfort in 7 (50%) of the 14 eyes, redness in 7 (50%) of the 14 eyes, and pain in 6 (43%) of the 14 eyes. Mean best-corrected logMAR visual acuity before EyePrintPRO fitting was 0.430 (Snellen 20/54; range, 20/ 20–20/200). After EyePrintPRO fitting, mean logMAR visual acuity was 0.03 (Snellen 20/21; range 20/10–20/60, p ¼ 0.001). Thirteen (93%) of the 14 eyes experienced a visual improvement, and all patients reported satisfaction with the scleral lens. Seven (88%) of the 8 eyes that were previous lens wearers before the EyePrintPRO experienced greater comfort and ability to wear the device for a longer period during the day. Most eyes (93%) experienced resolution of blurry vision, and all eyes experienced improvement of their symptoms of dry eye, redness, and/or pain. Two eyes (14%) experienced fogging and needed to clean the lens after 4–6 hours of wear.
Fig. 1 — Computerized 3D image of the mold taken of the eye of patient 10. Green overlay indicates the shape of the EyePrintPRO scleral lens to be lathed. The gray circle demonstrates the limbus. The back surface of the lens shows clearance over the cornea and limbus and lands on the sclera. (Photo courtesy of Advanced Vision Technologies.)
Fig. 2 — Computerized 3D image of the mold taken of the eye of patient 9. The patient’s eye has irregular pinguecula and conjunctival chalasis present on both the nasal and temporal side. The EyePrintPRO was successfully fitted on this patient’s eye. (Photo courtesy of Advanced Vision Technologies.)
Lens Type
Bearing
Corneal
Lens rests entirely on the cornea.
Corneo-scleral
Lens rests partly on the cornea, partly on the sclera.
Scleral A. Mini-scleral: lens is up to 6 mm larger than HVID. B. Large-scleral: lens is more than 6 mm larger than HVID.
Lens rests entirely on the sclera.
HVID, horizontal visible iris diameter.
METHODS
2
CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
EyePrintPRO therapeutic scleral contact lens—Nguyen et al. Table 2—Clinical characteristics of patients fitted with the EyePrintPRO scleral lens
Case No.
Pt Age, No. y Sex
Disease
BCVA Without Contact Lens
Daily Lens Wear (h)
BCVA with Other Scleral/ BCVA with Eye Corneal Lens EyePrintPRO
1
1
27
F
Limbal stem cell deficiency
20/200
8
R
20/30
20/25
2 3
2 2
52 52
M M
Post-PRK Post-PRK
20/20 20/200
8 8
R L
20/20 20/40
20/10 20/20
4
3
54
M
N/A
16
L
20/25
20/20
5
4
21
M
Pellucid marginal degeneration Stevens-Johnson syndrome þ limbal stem cell deficiency
N/A
16
L
20/60
20/30
6 7
5 5
38 38
M M
Keratoconus Keratoconus
20/60 20/20
10 10
R L
N/A N/A
20/25 20/20
8 9
6 6
57 57
F F
Dry eye Dry eye
20/20 20/20
16 16
R L
N/A N/A
20/20 20/20
10
7
59
M
20/60
14
R
N/A
20/25
11
7
59
M
20/25
14
L
N/A
20/20
12
8
67
M
20/200
16
R
20/70
20/30
13
9
57
M
Neurotrophic keratitis Neurotrophic keratitis Facial nerve paralysis Post-PK
N/A
16
R
20/25
20/20
14
10
54
M
Post-RK
N/A
5
L
20/40
20/25
Additional Notes Pt had scleral irregularities and conjunctival breaks causing pain and impingement with previous scleral lens. Superficial punctate keratopathy resolved with EyePrintPRO wear. Pt had decentred ablation with secondary corneal scarring OS 4 OD. Scleral lens fitting was unsuccessful at multiple centres throughout the United States because of fogging and dissatisfaction in vision. Pt had discomfort and hyperemia with previous scleral lens wear. Pt had reduction in vision and severe conjunctival chemosis and hyperemia with habitual scleral lens. Pt’s conjunctivalization over corneal surface remained stable over follow-up period. Pt unsuccessfully sought comfort from corneal and scleral lenses over a 15-year period before EyePrintPRO. Pt had exhausted all other treatments for chronic Meibomian gland dysfunction and lagophthalmos. Her sclera was highly irregular, making traditional scleral lens fitting challenging before EyePrintPRO. Pt had a large conjunctival cyst that the EyePrintPRO was successfully able to fit over.
Facial nerve paralysis limited the patient’s blink reflex, which lead to fogging of past scleral lens wear. Pt had a protruding graft that was more elevated in the peripheral cornea, making traditional scleral lens fitting challenging before EyePrintPRO. Pt had a pingueculum and raised peripheral cornea and was not able to wear traditional scleral lenses without hyperemia.
Pt, patient; BCVA, best-corrected visual acuity; PK, penetrating keratoplasty; PRK, photorefractive keratectomy; RK, radial keratotomy.
DISCUSSION
This novel series of 14 eyes of 10 patients fitted with the EyePrintPRO demonstrates that the EyePrintPRO can successfully treat a variety of eye diseases, including limbal stem cell deficiency, post-PRK decentred ablation, pellucid marginal degeneration, Stevens-Johnson syndrome, keratoconus, dry eye, neurotrophic keratitis, exposure keratitis from facial nerve paralysis, and post-RK symptoms. Many of these diseases have limited treatment options, such as deep anterior lamellar keratoplasty or penetrating keratoplasty, but these would incur intraoperative and rejection risks and would require the patient to be on long-term steroids.12 Scleral lens therapy has been reported to treat patients with limbal stem cell deficiency and possibly delay the need for limbal stem cell transplantation, keratoprosthesis implantation, or penetrating keratoplasty.13 Our patient with limbal stem cell deficiency (case 1) had failed with multiple attempts at conventional scleral lenses because the sclera was highly irregular and resulted in impingement (excess conjunctival pressure). The EyePrintPRO was able to gently land over the irregular regions of the sclera while still vaulting the cornea for a more comfortable fit. A study by Schornack reported the ability of a scleral lens to successfully treat a patient with progressively
worsening limbal stem cell deficiency, delaying the need for limbal stem cell transplantation and associated systemic immunosuppression.14 Similar scleral irregularities, such as a conjunctival cyst (case 10), large pingueculum (case 14), and a highly asymmetric sclera (cases 8 and 9), also presented challenges in the fitting of conventional spherical and toric scleral lenses before being fitted with the EyePrintPRO scleral lens. Patients with severe ocular surface disease such as Stevens-Johnson syndrome, neurotrophic keratitis, and facial nerve paralysis often can exhaust traditional dry eye interventions and the limited surgical treatments that are available to them, except for tarsorrhaphy, which is not ideal functionally or cosmetically. In fact, in our series, a patient with facial nerve paralysis (case 12) had a partial tarsorrhaphy but still presented with severe exposure keratitis. Interestingly, his previous conventional scleral lens produced high anterior surface fogging, whereas the EyePrintPRO did not. Use of the lens reduced the epitheliopathy and improved his vision to 20/30. Furthermore, his epitheliopathy was reduced from grade 4 confluent to trace epitheliopathy. This patient was able to better tolerate the EyePrintPRO than other scleral lenses for 2 reasons: (i) the fit was more precise, and (ii) the EyePrintPRO was treated with Hydra-PEG CAN J OPHTHALMOL — VOL. ], NO. ], ] 2017
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EyePrintPRO therapeutic scleral contact lens—Nguyen et al. technology, a coating that improves wettability, increases lens surface water retention, and minimizes lens fogging. This enabled him to wear the EyePrintPRO for longer periods without blurred vision, and he applied less artificial tears as a result.15 In 2013, Weyns et al. reported that scleral contact lenses were a valid treatment alternative to tarsorrhaphy for patients with facial nerve paralysis, even 18 years after the original lens fitting.16 Our current study shows that the EyePrintPRO has been successfully fitted in patients with these ocular surface diseases and can offer an additional treatment option for patients who have ocular surface disease refractory to other treatments or conditions for which surgical intervention is not ideal. Our study demonstrated that BCVA of 20/30 or better was achieved in all 14 of the patient eyes. This finding is consistent with previous reports.17 Furthermore, all patients in our study reported improvement of dry eye, redness, or pain symptoms. Almost all (93%) of the patients experienced resolution of their blurry vision and were extremely satisfied with the results. A recent literature review suggests that subjective patient satisfaction was actually the best indicator of performance of scleral contact lenses from the patients’ standpoint.6 Most patients referred for treatment in this study had failed previous attempts at contact lens rehabilitation of their vision, and many had also failed further treatment with advanced modalities such as specialty contact lenses, soft and corneal rigid gas-permeable contact lenses, piggyback systems, and hybrid and conventional scleral lenses. All patients reported increased satisfaction with the EyePrintPRO compared with past failed treatment modalities. The reason for this is likely the process by which the EyePrintPRO is customized to each patient case. There has been a long history of comfort and visual and therapeutic benefits of scleral contact lenses; however, the fitting process of the EyePrintPRO makes it unique. Instead of requiring a series of standardized curvatures as with conventional scleral lenses, the mold used to configure the EyePrintPRO is generated to match the unique irregularities of the individual eye. Thus, the EyePrintPRO is a completely custom scleral lens that matches the exact contours of the anterior surface of the globe. The importance of this is evident when looking at the indications for use of the lens, most of which are characterized by extreme ocular surface irregularities. Common complications of scleral lens wear, including bulbar redness, conjunctival blanching or impingement, and scleral lens adhesion, were reduced or eliminated in this case series. Widespread adoption of conventional scleral lenses has been limited because of the steep learning curve, the timeintensive fitting process, and the reliance on the expertise of the lens-fitting specialist.6 With the EyePrintPRO, the efficient impression mold technique is a simplified approach that could reduce interpractitioner variability in the fitting of the lenses. The development of the EyePrintPRO scleral lens provides an additional
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option among the wide range of currently available scleral lenses. There are some limitations of the EyePrintPRO scleral lens. The applicator device used to make the mold is 26 mm in diameter. If a patient has a narrow interpalpebral fissure or irregularities of the conjunctiva, such as symblephara or adhesions, it may be challenging to insert the applicator device. In many cases, smaller custom applicators need to be ordered. Additional limitations are similar to other scleral lenses in general. Scleral lenses limit tear turnover under the lens, leading to tear stagnation.18 Tear stagnation can result in decreased visual acuity and may increase the chance of microbial keratitis.6 We did not find a similar drop in visual acuity, but 2 (14%) of the 14 eyes experienced discomfort and fogging. These symptoms resolved after the patients removed their lens once or twice a day to clean them with fresh saline. There were no adverse events of infectious keratitis in our series. This study is limited by its retrospective nature. However, it is the first series in the literature to present the indications and outcomes of a heterogeneous patient population that has been fitted with the EyePrintPRO scleral lens. The preliminary results in this study illustrate that this device is effective and could have a place in the treatment algorithm for these complex patients. No complications related to the use of the EyePrintPRO (corneal opacifications or infections) were identified in this study, but longer follow-up is required. Future studies could include a comfort grading scale to help provide more objective measures of improvement; a validated dry eye survey such as the Ocular Surface Disease Index could be used to assess symptoms; and a patient quality-of-life questionnaire could also be incorporated. In summary, this study is the first series in the literature to report on the variety of indications for the EyePrintPRO, a scleral lens that uses a mold technology with 3D scanning to create a truly customized fit for patients with scleral and corneal irregularities. Patient outcomes in our series were positive. The comprehensive ophthalmologist should be aware that this new therapeutic scleral lens exists as an addition to the armamentarium of options for patients who have failed other lenses, have severe ocular surface disease, or have conditions in which surgical intervention is best to be delayed or obviated. REFERENCES 1. Romero-Rangel T, Stavrou P, Cotter J, et al. Gas-permeable scleral contact lens therapy in ocular surface disease. Am J Ophthalmol. 2000;130:25-32. 2. Pecego M, Barnett M, Mannis MJ, et al. Jupiter scleral lenses: the UC Davis Eye Center experience. Eye Cont Lens. 2012;38:179-82. 3. Deloss KS, Nadeem HF, Hood CT. Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) scleral device compared to keratoplasty for the treatment of corneal ectasia. Am J Ophthalmol. 2014;158:974-82. 4. Heur M, Bach D, Theophanous C, et al. Prosthetic replacement of the ocular surface ecosystem scleral lens therapy for patients with
EyePrintPRO therapeutic scleral contact lens—Nguyen et al.
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ocular symptoms of chronic Stevens-Johnson syndrome. Am J Ophthalmol. 2014;158:49-54. Rosenthal P, Croteau A. Fluid-ventilated, gas-permeable scleral contact lens is an effective option for managing severe ocular surface disease and many corneal disorders that would otherwise require penetrating keratoplasty. Eye Cont Lens. 2005;31:130-4. van der Worp E, Bornman D, Ferreira DL, et al. Modern scleral contact lenses: a review. Cont Lens Ant Eye. 2014;37:240-50. Rathi VM, Mandathara PS, Taneja M, et al. Scleral lens for keratoconus: technology update. Clin Ophthalmol. 2015;9:2013-8. Stason WB, Razavi M, Jacobs DS, et al. Clinical benefits of the Boston ocular surface prosthesis. Am J Ophthalmol. 2010;149:54-61. Theophanous C, Irvine JA, Parker P, et al. Use of prosthetic replacement of the ocular surface ecosystem scleral lenses in patients with ocular chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2015;21:2180-4. Ling JD, Gire A, Pflugfelder SC. PROSE therapy used to minimize corneal trauma in patients with corneal epithelial defects. Am J Ophthalmol. 2013;155:615-9. Samini DB, Chiu GB, Burnstine MA. PROSE scleral lens: a novel aid for staged eyelid reconstruction. Ophthal Plast Reconstr Surg. 2014;30:119-21. Patel SV, Hodge DO, Bourne WM. Corneal endothelium and postoperative outcomes 15 years after penetrating keratoplasty. Am J Ophthalmol. 2005;139:311-9. Sejpal K, Yu F, Aldave AJ. The Boston keratoprosthesis in the management of corneal limbal stem cell deficiency. Cornea. 2011;30:1187-94. Schornack MM. Limbal stem cell disease: management with scleral lenses. Clin Exp Optom. 2011;94:592-4. Sindt CW. Tangible™ Hydra-PEG: a novel custom contact lens coating technology designed to improve patient comfort and satisfaction (white paper) 2016 Retrieved July 19, 2017, from 〈http://docs.wixstatic.com/ugd/dd2daf_6d730c1482f6450396c734 d74c3017b6.pdf〉. Weyns M, Koppen C, Tassignon MJ. Scleral contact lenses as an alternative to tarsorrhaphy for the long-term management of
combined exposure and neurotrophic keratopathy. Cornea. 2013;32: 359-61. 17. Pullum KW, Whiting MA, Buckley RJ. Scleral contact lenses: the expanding role. Cornea. 2005;24:269-77. 18. Ko L, Maurice D, Ruben M. Fluid exchange under scleral contact lenses in relation to wearing time. Br J Ophthalmol. 1970;54: 486-9.
Footnotes and Disclosure: Clara C. Chan has received honoraria from Alcon Labs Inc (Fort Worth, TX), Allergan (Parsippany, NJ), Bausch & Lomb (Rochester, NY), and Tearscience (Morrisville, NC). Vishakha Thakrar has received honoraria from Johnson & Johnson Vision Care (Jacksonville, FL), Alcon Labs Inc (Fort Worth, TX), Allergan (Parsippany, NJ), and Blanchard Contact Lens Inc (Manchester, NH). Michael T.B. Nguyen has no financial disclosures. From the *Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ont; †Vaughan Family Vision Care, Vaughan, Ont; ‡Kensington Eye Institute, Toronto, Ont; § Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont. Originally received Jan. 21, 2017. Final revision Jul. 21, 2017. Accepted Jul. 26, 2017. Correspondence to Clara C. Chan, MD, Department of Ophthalmology and Vision Sciences, University of Toronto, 600 Sherbourne Street, Suite 601, Toronto, Ont. M4X1W4; [email protected]
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