Macular Hole Surgery With Inner Limiting Membrane Peeling, Endodrainage, and Heavy Silicone Oil Tamponade

Macular Hole Surgery With Inner Limiting Membrane Peeling, Endodrainage, and Heavy Silicone Oil Tamponade

Macular Hole Surgery With Inner Limiting Membrane Peeling, Endodrainage, and Heavy Silicone Oil Tamponade ANNELIES SCHURMANS, JOACHIM VAN CALSTER, AND...

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Macular Hole Surgery With Inner Limiting Membrane Peeling, Endodrainage, and Heavy Silicone Oil Tamponade ANNELIES SCHURMANS, JOACHIM VAN CALSTER, AND PETER STALMANS ● PURPOSE:

To evaluate the anatomical and functional outcomes in macular hole (MH) patients who underwent vitrectomy with inner limiting membrane (ILM) peeling, endodrainage, and heavy silicone oil (HSO) endotamponade. ● DESIGN: A retrospective case series with 54 consecutive eyes from 53 patients with idiopathic stage 3 or 4 MHs. ● METHODS: Surgery with infracyanine green-assisted ILM peeling and endodrainage was performed. Patients who were phakic underwent a simultaneous phacoemulsification. At the end of the operation, a HSO tamponade was used in all cases. The patient maintained a face-up position for 24 hours postoperatively. The HSO was removed two to three months after initial surgery. Optical coherence tomography was performed preoperatively and postoperatively to determine the MH stage and the anatomical closure rate. ● RESULTS: The mean follow-up time was 6.6 months (range, 3.6 to 18.2 months). The overall median duration between the first symptoms and the surgery was four months (range, two to 37 months). The overall anatomical closure success rate after one surgery was 100%. The median preoperative visual acuity (VA) was 20/200 (range, 20/40 to 20/600) and increased to 20/50 (range, 20/20 to 20/300) postoperatively. The median increase in VA was five lines (mean, 4.8 lines; range, –3 to 12 lines). Of all 54 eyes, 30 (55 %) eyes had a final VA of 20/50 or better. ● CONCLUSIONS: These findings indicate that surgery for MH with ILM peeling, endodrainage, and HSO endotamponade appears to induce a high incidence of anatomical closure with good visual outcome. (Am J Ophthalmol 2009;147:495–500. © 2009 by Elsevier Inc. All rights reserved.)

M

ACULAR HOLES (MHS) ARE A CAUSE OF DETERI-

orated central vision in the elderly, and they show a strong female predominance. The prevalence of MHs is 3.3 in 1,000. Since the description of pars plana vitrectomy (PPV) for idiopathic holes by Kelly and See accompanying Editorial on page 381. Accepted for publication Sep 2, 2008. From the Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium. Inquiries to Peter Stalmans, Department of Ophthalmology, University Hospitals Leuven, Capucijnenvoer 33, B3000 Leuven, Belgium; e-mail: [email protected] 0002-9394/09/$36.00 doi:10.1016/j.ajo.2008.09.003

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Wendel in 1991,1 many new techniques have been developed to facilitate surgery and improve results. The current surgical approach consists of a PPV with removal of the vitreoretinal foveal traction. To improve cell migration for MH closure after surgery, a smooth template must be provided. A gas or silicone oil bubble is generally used, but postoperative positioning is required. This postoperative face-down positioning is sometimes a challenge for the patient. Heavy silicone oil (HSO) has been designed to overcome the disadvantages of silicone oil and gas tamponades because they are heavier-than-water tamponade agents. Because of their increased density, they provide a good tamponade of both the inferior and posterior pole in normal head posturing, making postoperative face-down positioning no longer necessary.

METHODS IN THIS RETROSPECTIVE STUDY, 53 CONSECUTIVE CON-

senting patients (54 eyes) with stage 3 or 4 MHs were operated on between November 1, 2004 and January 1, 2006. Inclusion criteria were the presence of idiopathic stage 3 or 4 MHs, as determined by indirect ophthalmoscopy and optical coherence tomography (OCT) imaging. Exclusion criteria were preproliferative and proliferative diabetic retinopathy, age-related macular degeneration, high myopia, traumatic MH, and previous retinal detachment (RD) surgery. MH size was measured and recorded with OCT imaging using standard OCT 2 or Stratus OCT software (Humphrey-Zeiss, San Leandro, California, USA). Staging of the MH in all patients was done using Gass classification modified by OCT imaging.2 Stage 3 holes have no retinal tissue on the bottom of the MH and an operculum with incomplete posterior vitreous detachment (PVD). In stage 4 MHs, a complete PVD is present. At present, two types of HSO are available: Oxane HD (Bausch & Lomb, St Louis, Missouri, USA) and Densiron 68 (Fluoron, Neu-Ulm, Germany). Details of both their chemical and physical properties are listed in Table 1. There are publications describing some intraocular inflammation and stickiness with the use of OxaneHD,3 and therefore we obtained Densiron68 HSO. The surgery was conducted similarly by two surgeons (P.S. and J.V.C.). Only two eyes (4%) were operated on

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TABLE 1. Properties of Heavy Silicone Oils

TABLE 2. Conversion Table for Snellen Best-Corrected Visual Acuity to Line Score

Properties of Densiron68a Physical Properties Viscosity [mPas at 25 C] 1400 Density [g/cm3 at 25 C] 1.06 Solubility in water nonmiscible Refractive index 1.3870 Properties of OxaneHDb Physical Properties Viscosity [cSt] 3800, [mPas at 25 C] 3300 Density [g/cm3 at 25 C] 1.03 Refractive index 1.40 Volatility ⬍0.1% Surface tension ⬎ 40mN/m RMN3 volume 11.9% a Densiron68 is chemically and physiologically inert and does not contain any low molecular, particularly cyclical, siloxanes - is free from ionic compounds and do not contain any separable fluoride. Densiron68 is a homogeneous mix of polydimethyl siloxane (CH3)3SiO-[Si(CH3)2O]n-Si(CH3)3 (69.5%) and perfluorohexyloctane (F6H8) (30.5%). b OxaneHD is a mixture of silicone oil (Oxane 5700, Bausch & Lomb) and mixed fluorinated and hydrocarbinated olifin (RMN3), this mixture is homogeneous and stable in the presence of water, air or perfluorocarbon.

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LogMAR

Line Score

20/20 20/25 20/30 20/40 20/50 20/60 20/80 20/100 20/120 20/160 20/200 20/250 20/300 20/400 20/600

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4

16 15 14 13 12 11 10 9 8 7 6 5 4 3 2

BCVA ⫽ best-corrected visual acuity; logMAR ⫽ logarithm of the minimal angle resolution.

the hole. Patients were examined on postoperative day 1 and 2, week 2, and every two months thereafter. Follow-up time was at least 3.6 months, and the mean follow-up time was 6.6 months. The removal of HSO was performed two to three months after the initial surgery, similar to the procedure used in our center with normal silicone oil.5 The removal of HSO was done through the pars plana was done via active suction (550 mm Hg). Preoperative data, including the age and gender of the patient, duration of the MH, stage and size of the MH by OCT imaging, lens status of the patient, unilaterality or bilaterality of the MH, and best-corrected visual acuity (BCVA), were recorded. Intraoperative data, including any concurrent surgical procedures, ease of the ILM peel, presence or absence of ERM, and any other intraoperative complications, were noted. Postoperative data, including anatomical macular status by OCT imaging, BCVA, and reading ability, were recorded. All postoperative complications attributable to surgery and postoperative intraocular pressure (IOP) were recorded. Snellen visual acuity (VA) was determined using a Snellen chart. Acuity was then converted to a logarithm of the minimal angle resolution algorithm to convert into a line score to record the number of lines gained or lost after surgery (Table 2). Data were tabulated using Microsoft Excel (Microsoft Corp, Redmond, Washington, USA).

under local anesthesia; the other 52 (96%) were performed under general anesthesia. All eyes underwent a complete PPV with vitreous base shaving. A 20-gauge vitrectomy was performed in the first 45 cases. Nine patients underwent 23-gauge sutureless vitrectomy. If no PVD was present, elevation of the posterior hyaloid was induced via suction of the vitrectome. An epiretinal membrane (ERM) was removed, if present. Infracyanine green 0.5% 0.2 ml (osmolarity of 309 mOsm/kg)4 was injected into all eyes, and a peeling of the inner limiting membrane (ILM) was performed with intraocular end-gripping forceps (DORC, Zuidland, The Netherlands). Endodrainage of the MH was performed under perfluorocarbon liquid (PFCL) with a 30-gauge blunt-tipped needle mounted on a backflush hand piece.5 This endodrainage technique allowed the surgeon either to close the MH peroperatively or reduce the size of larger MHs to increase the chances of complete closure postoperatively. All patients received 360 degrees endolaser treatment at the vitreous base to prevent postoperative RD. Concurrent phacoemulsification and implantation of a one-piece acrylic posterior chamber lens implant (Acreos Adapt; Bausch & Lomb) were performed in all patients except those already pseudophakic. A PFCL to air exchange was performed at the end of the surgery, and HSO was injected under air until digital normotension was achieved. After surgery, the patients were positioned their backs facing up for 24 hours. Imaging of the MH using ophthalmoscopy and OCT on the first postoperative day was done to confirm closure of 496

Snellen BCVA

RESULTS FIFTY-FOUR EYES OF 53 CONSECUTIVE ELIGIBLE PATIENTS

with follow-up of at least 3.6 months were recruited, and all were included in the final analysis. No patient was lost OF

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TABLE 3. Detailed Patient Data Macular Hole Surgery With Heavy Silicone Oil Case No.

Age/Gender

Duration MH (mos)

Hole Size (␮m)

Eye

Preoperative VA

Also Phaco

FU (mos)

Postoperative VA

Lines of Improvement

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54

72 F 74 M 64 F 69 F 61 F 71 F 74 F 71 F 77 F 59 F 60 F 78 F 69 F 60 F 75 F 65 F 79 F 63 F 69 F 72 F 63 F 67 M 71 M 63 F 66 M 69 F 69 M 66 F 71 F 72 F 61 F 71 F 71 M 60 F 63 F 82 M 61 M 67 F 75 F 63 M 76 F 64 F 74 M 72 F 80 F 76 F 69 M 51 M 71 F 58 M 71 F 75 F 71 M 67 F

37 2 3 4 3 6 8 N/A 10 6 25 6 5 3 6 4 2 3 7 N/A N/A 16 2 4 4 5 N/A 9 3 N/A 4 4 13 4 N/A 6 3 3 13 5 15 4 3 5 N/A N/A 6 3 3 5 N/A 4 6 3

797 797 703 1047 750 609 880 516 646 609 604 891 483 797 1406 797 563 684 1172 938 492 523 539 885 984 703 797 938 1127 1313 328 469 797 469 609 523 609 328 563 516 750 375 703 1078 750 375 797 984 586 402 984 563 469 750

OD OS OS OS OD OS OD OD OD OS OD OD OD OD OD OD OD OD OS OS OD OS OD OD OD OD OS OS OS OS OD OS OD OD OD OD OD OS OD OD OD OS OS OS OD OD OS OS OD OS OD OS OS OS

20/400 20/50 20/160 20/200 20/600 20/60 20/100 20/200 20/120 20/40 20/60 20/160 20/100 20/160 20/600 20/400 20/300 20/400 20/400 20/200 20/300 20/100 20/200 20/400 20/40 20/160 20/300 20/300 20/600 20/400 20/200 20/200 20/120 20/60 20/160 20/60 20/100 20/40 20/250 20/160 20/600 20/50 20/600 20/250 20/120 20/200 20/400 20/60 20/300 20/160 20/60 20/160 20/300 20/300

Before Yes Yes Before Yes Before Before Before Yes Yes Yes Before Yes Before Yes Before Yes Yes Yes Yes Yes Yes Yes Yes Yes Before Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Before Before Yes Before Yes Before Before Before Yes Yes Yes Yes Yes Yes Yes Yes Yes

6.7 4.0 5.0 7.9 4.8 7.6 6.2 5.0 7.6 7.0 6.4 10.3 4.4 6.7 5.6 6.7 6.1 5.5 4.3 9.4 5.1 3.9 5.1 4.6 8.1 4.1 5.4 5.7 4.4 18.2 5.7 10.7 5.5 4.3 9.1 3.9 11.3 5.2 5.2 4.7 6.1 5.9 7.9 4.6 11.7 8.3 4.5 8.0 17.5 3.7 9.2 4.2 3.6 5.2

20/50 20/33 20/33 20/60 20/120 20/50 20/50 20/33 20/80 20/20 20/60 20/40 20/25 20/100 20/160 20/30 20/300 20/60 20/100 20/60 20/80 20/60 20/40 20/60 20/80 20/40 20/25 20/120 20/250 20/33 20/30 20/160 20/80 20/20 20/40 20/40 20/40 20/33 20/50 20/50 20/160 20/40 20/30 20/50 20/80 20/50 20/40 20/33 20/300 20/60 20/40 20/33 20/100 20/60

9 2 6 5 6 1 3 8 2 3 0 6 6 2 5 9 0 8 6 5 6 2 7 8 ⫺3 6 11 4 3 10 8 1 2 5 6 2 4 1 7 5 5 1 12 7 2 6 10 2 0 4 2 7 5 7

F ⫽ female; FU ⫽ follow-up; M ⫽ male; MH ⫽ macular hole; mos ⫽ months; N/A ⫽ not available; OD ⫽ right eye; OS ⫽ left eye; VA ⫽ visual acuity.

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in follow-up. An uneven gender distribution was found: 39 patients (40 eyes) were female, and 14 patients (14 eyes) were male (male to female distribution of 1/2.8). The median age of the patients was 69 years (range, 51 to 82 years). We included only stage 3 and 4 MHs, as determined by OCT imaging.6 The average MH size was 717 ␮m (range, 328 to 1406 ␮m). The median MH duration was four months (range, two to 37 months), although nine durations (16%) were not recorded. Six (14%) chronic MHs, which were defined as those with a duration greater than 12 months, were present. Six patients (11%) had a bilateral MH, and 48 patients (89%) had a unilateral MH. We treated 31 (57%) right eyes and 23 (43%) left eyes. Thirty-seven eyes (69%) were treated by one surgeon (P.S.), and 17 (31%) were treated by the other (J.V.C.) Concurrent phacoemulsification and implantation of a posterior chamber one-piece acrylic lens implant was performed in 39 eyes (72%) before the PPV. The other 15 eyes (28%) were already pseudophakic. The last nine eyes were operated on with a 23-gauge system (17%); all 45 other eyes (83%) underwent a 20-gauge vitrectomy. Endodrainage was not performed in four cases that exhibited a very small MH diameter (Cases 9, 10, 14, and 29; Table 3). In each of the 54 eyes, HSO was injected as an endotamponade. The HSO was removed after a median period of 83 days (2.7 months), with a range between 48 and 156 days. A subchoroidal swelling, which was regressed at day 1 postoperative, occurred during the vitrectomy of two eyes (Case 7 during oil removal and Case 29 during the initial vitrectomy; Table 3). In three eyes, one or more iatrogenic retinal tears developed at the vitreous base and were successfully treated intraoperatively. Postoperatively, 18 eyes (33%) developed a transient IOP rise on the first postoperative day, and these rises were easily treated with topical antiglaucoma therapy. During follow-up after initial surgery, no silicone oil bubbles were found in the anterior chamber and no visible emulsification was noticed. In one patient (Case 11; Table 3), a secondary vitreous wash was necessary to remove retained oil. In one eye, an intravitreal injection of triamcinolone (4 mg) was administered for cystoid macular edema 45 days after removal of the HSO (Case 46; Table 3). There was doubt about the closure of the MH on OCT in one eye (Case 32; Table 3). Therefore, a SF6-gas tamponade was used in that case after removal of the HSO. The only patient with decreased VA after surgery complained of a green scotoma (Case 25; Table 3). Red-free photographs showed autofluorescence in his posterior pole. Follow-up ranged from 3.6 to 18.2 months (mean, 6.6 months; median, 5.6 months). Postoperative anatomical foveal aspect showed MH closure in all 54 eyes (100%). Median preoperative VA was Snellen 20/200 (range, 20/40 to 20/600) and median postoperative VA was Snellen 20/50 (range, 20/20 to 20/300). At the last follow-up, the median line improvement was five lines (mean, 4.8 lines; 498

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range, –3 to 12 lines). Forty-six eyes (85%) had improvement of two or more VA lines after surgery. Four eyes (7%) had a final VA within one line of the preoperative VA. Only one eye lost three lines of VA after surgery (Case 25; Table 3). For all the 54 eyes, 30 (55%) had a final VA of 20/50 or better. Although the follow-up was short (at least 3.6 months), no reopening of the MH was seen in any of the 54 eyes. No persistent IOP rise was recorded after removal of the HSO. No patient developed a RD afterwards. In the group that underwent concurrent cataract extraction, the mean lines of improvement were 4.5 (range, –3 to 11 lines). The mean line improvement in the 15 eyes that had a previous phacoemulsification was 5.1 (range, zero to 12 lines).

DISCUSSION IN THIS STUDY OF 54 EYES WITH IDIOPATHIC STAGE 3 OR 4

MHs treated with surgery and HSO tamponade, a primary anatomical closure rate of 100% was achieved. The primary anatomical success rate is similar to our previous study, in which normal silicone oil was used as an endotamponade.5 For classic MH surgery, a gas tamponade is used as a temporary endotamponade. With this gas tamponade, the patients are required to remain positioned face-down for three to 14 days postoperatively.7,8 The use of the HSO tamponade eliminates the need to position patients face-down postoperatively, and it produces a similar anatomical and visual outcome. The studies with gas and no positioning postoperatively to date9 –11 had a MH closure rate of 92%, 90%, and 88%, respectively. Therefore, we justify the use of HSO to obtain that 100% closure rate. Experience with the mixture of perfluorohexyloctane and silicone oil arises from the treatment of complex RDs and proliferative vitreoretinopathy (PVR) cases.2 The efficacy and safety of HSO tamponade was shown by Wong and associates.12–15 Rizzo and associates have already reported the successful treatment of two persistent MHs with HSO.16 Because silicone oil is an important content (69.5%) of HSO, its cataractogenous effect on the crystalline lens is probably similar to normal silicone oil. To prevent cataract formation attributable to HSO endotamponade, a concurrent phacoemulsification was performed in all phakic eyes. The technical possibility of complete shaving of the vitreous base in a pseudophakic patient was also a reason for a concurrent phacoemulsification. At the time of HSO removal, a posterior capsulotomy was made during surgery. There was no significant difference in the number of lines of improvement between the patients who underwent previous cataractextraction (mean, 5.1 lines improvement) and the patients who underwent a simultaneous cataract removal (mean, 4.5 lines improvement). This indicates OF

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that postoperative visual improvement is mainly attributable to MH closure rather than the cataract surgery. We did not encounter any serious ocular or systemic adverse effects. Previous reports of inflammatory reactions and stickiness after HSO use were not found in our 54 eyes.3,15 The injection and removal of Densiron68 was straightforward in our 54 eyes and no stickiness or other preoperative problems were noted. Postoperative retained oil droplets were seen in one patient (Case 11; Table 3). At present, ocular side effects of HSO endotamponade are poorly investigated, and further investigations are necessary. An international, multicentered, randomized, and controlled clinical trial comparing the safety and efficacy of HSO tamponade with that of normal silicone oil is currently running in Europe (HSO study). The peeling of the inner limiting membrane has been established by many authors as a safe procedure that produces good and stable functional and anatomical results.7,17 Although the safety of using infracyanine green 0.5% 0.2 ml (osmolarity of 309 mOsm/kg) at the level of the retinal pigment epithelium was demonstrated earlier,4 we note that one patient developed a scotoma after surgery that was likely attributable to infracyanine green toxicity

during surgery. We did not perform microperimetry on all our patients to determine the presence of paracentral scotomata. The peroperatively endodrainage of the MH is not a widely used technique. Our excellent results with endodrainage in combination with normal silicone oil and heavy oil tamponade, have convinced us to continue to use this technique. We realize that Jumper and Sato studied the postoperative closure of MHs with OCT with the use of a gas tamponade and without peroperative endodrainage.18,19 The mean number of lines of improvement in VA in our current study series was 4.8 (median, five lines), and 46 eyes (85%) had an improvement of two or more lines after surgery. Our functional results are similar to studies using gas or normal silicone oil as a tamponade agent.5,7 In summary, infracyanine-assisted ILM peeling, endodrainage, and HSO endotamponade in idiopathic stage 3 or 4 MHs appear to provide a promising anatomical closure rate and a good visual outcome. This procedure permits maximal patient comfort, since no face-down positioning is required. Moreover, the use of HSO allows a close follow-up using ophthalmoscopy and OCT beginning on the first postoperative day.

THE AUTHORS INDICATE NO FINANCIAL SUPPORT OR FINANCIAL CONFLICT OF INTEREST. INVOLVED IN DESIGN AND conduct of study (A.S., P.S.); data collection (A.S., P.S., J.V.C.); management, analysis, and interpretation of data (A.S., P.S.); and preparation, review, and approval of manuscript (A.S., P.S., J.V.C.). Approval of our Institutional Review Board (Ethics Committee of the University Hospitals Leuven IRB) was waived. This study adheres to the Declaration of Helsinki and HIPAA regulations.

REFERENCES 1. Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol 1991;109:654 – 659. 2. Tognetto D, Minutola D, Sanguinetti G, Ravalico G. Anatomical and functional outcomes after heavy silicone oil tamponade in vitreoretinal surgery for complicated retinal detachment: a pilot study. Ophthalmology 2005; 112:1574. 3. Theelen T, Tilanus MA, Klevering BJ. Intraocular inflammation following endotamponade with high-density silicone oil. Graefes Arch Clin Exp Ophthalmol 2004;242:617– 620. 4. Stalmans P, van Aken EH, Veckeneer M, Feron EJ, Stalmans I. Toxic effect of indocyanine green on retinal pigment epithelium related to osmotic effects of the solvent. Am J Ophthalmol 2002;134:282–285. 5. van De Moere A, Stalmans P. Anatomical and visual outcome of macular hole surgery with infracyanine greenassisted peeling of the internal limiting membrane, endodrainage, and silicone oil tamponade. Am J Ophthalmol 2003;136:879 – 887. 6. Azzolini C, Patelli F, Brancato R. Correlation between optical coherence tomography data and biomicroscopic interpretation of idiopathic macular hole. Am J Ophthalmol 2001;132:348 –355. 7. Haritoglou C, Reiniger IW, Schaumberger M, Gass CA, Priglinger SG, Kampik A. Five-year follow-up of macular

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18. Jumper JM, Gallemore RP, McCuen BW II, Toth CA. Features of macular hole closure in the early postoperative period using optical coherence tomography. Retina 2000;20:232–237. 19. Sato H, Kawasaki R, Yamashita H. Observation of idiopathic full-thickness macular hole closure in early postoperative period as evaluated by optical coherence tomography. Am J Ophthalmol 2003;136:185–187.

16. Rizzo S, Belting C, Genovesi-Ebert F, Cresti F, Vento A, Martini R. Successful treatment of persistent macular holes using “heavy silicone oil” as intraocular tamponade. Retina 2006;26:905–908. 17. Brooks HL Jr. Macular hole surgery with and without internal limiting membrane peeling. Ophthalmology 2000; 107:1939 –1948; discussion 1948 –1949.

AJO History of Ophthalmology Series The Earliest Fundus Visualization of Living Eyes

O

n November 12, 1704, in a presentation to the French Royal Academy of Sciences, Dr Jean Méry noted his observation that if a cat is immersed in water its retinal vessels became visible. On March 20, 1709, Philippe de La Hire pointed out that this was attributable to the abolition of the corneal refraction. Méry’s experiment of eye immersion for fundus visualization was repeated and

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supplemented later in humans in 1845 by Adolf Kussmaul; in 1851 by Johann Nepomuk Czermak, for the construction of the orthoscope; and in 1891 by Oswald Gerloff, for the earliest successful fundus photography. Provided by Robert F. Heitz, MD, PhD, of the Cogan Ophthalmic History Society.

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