- Email: [email protected]
A Randomized Controlled Trial Comparing Everting Sutures with Everting Sutures and a Lateral Tarsal Strip for Involutional Entropion
A Randomized Controlled Trial Comparing Everting Sutures with Everting Sutures and a Lateral Tarsal Strip for Involutional Entropion Marius A. Scheepers, MBBCh, MRCOphth,1 Ravi Singh, MBBCh,1 James Ng, MBBS, MRCOphth,1 Doris Zuercher, MD,1 Andrew Gibson, MBBS, FRCOphth,1 Catey Bunce, MSc, DSc,3 Ken Fong, MBBS, MRCOphth, FRCOphth,1,2 Michel Michaelides, MBBS, FRCOphth,3 Jane Olver, FRCS, FRCOphth1 Objective: To determine whether there is a statistically significant difference in the surgical outcome of everting sutures (ES) alone versus everting sutures with a lateral tarsal strip (ES⫹LTS) in the treatment of involutional entropion. Design: Prospective randomized comparative trial. Participants: Sixty-three patients with primary involutional lower eyelid entropion were enrolled in the study. The age range was 54 to 94 years, with a mean age of 77 years. Baseline characteristics of the comparative groups were similar. Methods: Patients requiring primary surgical repair for involutional entropion were selected, and those providing informed consent were randomized for surgery. Thirty-six patients were randomized to ES alone, and 27 patients were randomized to ES⫹LTS. Patients were evaluated at 3 weeks and 6, 12, and 18 months postoperatively. Main Outcome Measures: Successful surgery was defined as a normal eyelid position at rest and inability to induce entropion on tetracaine provocation testing at or before the 18-month follow-up visit. Results: Eight patients were lost to follow-up (7 had ES alone). Of the 55 patients with complete follow-up data, there were 6 failed procedures in the patients who underwent ES alone and no failed procedures in the patients who underwent ES⫹LTS (P ⫽ 0.02). Conclusions: These data provide strong evidence that success rates at 18 months are higher in patients treated with ES⫹LTS procedure compared with ES alone. Financial Disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2010;117:352–355 © 2010 by the American Academy of Ophthalmology.
Involutional entropion is a common lower lid malposition. Without treatment the condition can cause ocular discomfort, epiphora, and corneal ulceration with the potential development of microbial keratitis and a subsequent risk of visual loss. The underlying pathogenesis of involutional entropion is multifactorial. The factors thought to be involved include horizontal eyelid laxity, vertical lower lid laxity secondary to inferior retractor laxity and dehiscence, migration of the preseptal orbicularis muscle over the pretarsal orbicularis muscle, and appositional pressure during forced eyelid closure over a shrunken tarsal plate.1– 4 Conservative treatment is likely to provide only temporary relief and includes the use of topical lubricants, taping of the lower lid, or botulinum toxin chemo-denervation.5 Surgery is, however, the mainstay of treatment and addresses the underlying anatomic pathology of the condition.6 Many surgical procedures with varying long-term success rates have been described for the treatment of entropion.1,4,6 –11 The use of everting sutures (ES) alone is advocated by many surgeons because of the advantages of being quick and relatively simple to perform, and anticoagulation treatment does not need to be omitted compared with more invasive eyelid procedures.7 Placement of ES rotates the eyelid mar-
352
© 2010 by the American Academy of Ophthalmology Published by Elsevier Inc.
gin anteriorly and tightens the inferior retractors. However, it has not been determined whether a horizontal eyelid tightening procedure in conjunction with ES significantly improves the success rate of treating involutional entropion. We have therefore conducted a prospective, randomized comparative trial assessing the relative efficacy of treating involutional entropion with ES and horizontal eyelid shortening using the lateral tarsal strip (LTS) procedure (ES⫹LTS) compared with ES alone. To the best of our knowledge, this is the first comparative randomized trial to evaluate the success rates of 2 entropioncorrecting procedures.
Materials and Methods From statistical analysis, the sample size calculation required 110 patients per treatment group to have 90% power to detect a significant difference between the 15% entropion recurrence rate reported by Wright et al7 for ES and the 2% entropion recurrence rate reported by Barnes et al6 for ES⫹LTS. We therefore designed a multicenter trial and set out to recruit in excess of 110 patients from 5 treatment centers, but lack of research staff resulted in 2 hospitals withdrawing from the study before commencing patient ISSN 0161-6420/10/$–see front matter doi:10.1016/j.ophtha.2009.06.056
Scheepers et al 䡠 EVS Compared with EVS⫹LTS enrollment. We were only able to recruit 63 patients after an 18-month time period, after which we decided to perform statistical analysis on the available data. Patients were recruited independently from other studies. Exclusion criteria included a history of previous lower lid surgery, patients with grade 4 medial canthal tendon laxity by the lateral distraction test (grade 4 laxity is where the lower lid punctum can be pulled laterally to the center of the pupil),12 and excessive horizontal eyelid laxity secondary to floppy eyelid syndrome. If the horizontal eyelid laxity exceeded 13 mm, the patient was excluded. Horizontal eyelid laxity was determined using the pinch test. This test is performed by grasping the lower lid skin over the central aspect of the lower lid tarsal plate and pulling the lower lid away from the globe. The distance between the globe and the posterior aspect of the lower lid is then measured and recorded as the horizontal eyelid laxity measurement.12 Institutional ethics committee approval was obtained, and patients were recruited with informed consent. Eligible patients were randomized to ES or ES⫹LTS by drawing an envelope from a box that contained 1 of the 2 randomization assignments, with half the patients randomized to ES and the other half to ES⫹LTS. For patients with bilateral disease, only the first eyelid operated on was entered into the study.
Surgical Methods Surgery was performed under local anesthesia in all patients. Local anesthesia included tetracaine eye drops in the conjunctival sac and subcutaneous infiltration of the lower eyelid with half-and-half by volume of lidocaine 2% with 1:200 000 epinephrine and bupivacaine 0.5%. For ES⫹LTS, the lateral canthus was also infiltrated down to the periosteum along with the lateral third of the upper eyelid.
Everting Sutures Technique Four ES (6-0 double-armed polyglactin) were inserted through the conjunctiva deep within the inferior fornix. The sutures were equally spaced within the lateral two thirds of the lower lid, as has been described.7,9,10 Each suture end is passed approximately 2 to 3 mm next to its fellow. The sutures emerge through the skin approximately 2 to 4 mm below the lash line where their ends are initially secured with bulldog clips (small clips used for holding suture thread) before being tied firmly and trimmed once all the sutures are placed. The aim is to induce a slight overcorrection of the entropion. Sutures are not placed in the medial one third of the lower lid where they may cause a punctal ectropion and epiphora. The sutures are left in situ to bury and create scarring as they dissolve, helping to create an adhesion between the tightened inferior retractors and inferior tarsal plate.
Lateral Tarsal Strip and Everting Sutures A lateral canthotomy and inferior cantholysis are initially performed. A “tarsal strip” is fashioned from the lateral lower eyelid by stripping the superior mucocutaneous junction tissue, debriding conjunctival epithelium posteriorly, excising the anterior lamella, and making a linear incision inferiorly to create a “tendon” of tarsal plate.8 The length of the fashioned tendon is determined by assessing the desired tension required to tighten the lower eyelid. After the creation of the LTS, the ES are performed in the fashion described previously, with the sutures being placed having taken into account the new lateral extent of the lower eyelid. The tarsal strip is attached to the internal lateral orbital rim with a double-armed 5-0 polyglactin suture by creating a slip knot at the tendon and passing the 2 suture ends through the internal orbital
portion of the lateral orbital rim periosteum.8 The aim is to slightly overcorrect the height of the eyelid by placing the suture slightly more superiorly than the lateral canthal angle while maintaining a posterior vector of tension. Just before tying this suture, lateral canthal reformation is achieved with a single buried 6-0 polyglactin suture. Deep buried 6-0 polyglactin suture is used to close the lateral canthal orbicularis muscle followed by skin closure with interrupted 7-0 polyglactin suture.
Postoperative Care Chloramphenicol ointment was instilled in the inferior conjunctival fornix and suture sites for both ES and ES⫹LTS, and paraffin gauze and a double eye pad were used for a firm dressing for 24 hours for ES⫹LTS. After both procedures, patients were asked to instil chloramphenicol 0.5% eye drops 4 times per day for 3 weeks according to standard departmental protocol for eyelid surgery. Patients were asked to take care not to pull on their lower lid when instilling the drops because it could increase the risk of dehiscence. The first postoperative review in the outpatient clinic was 3 weeks after surgery. Patients were then reviewed again at 6, 12, and 18 months postoperatively by an unmasked medical practitioner. All patients were followed up for a minimum of 18 months to ensure that late failures were detected.11 Successful surgery was defined as resolution of entropion confirmed with a tetracaine provocation test in the presence of a normal eyelid position.12 Surgical failure was defined as a recurrence of entropion at rest or after the tetracaine provocation test at or before the 18-month follow-up visit, or secondary ectropion that persisted for more than 2 months after surgery.
Statistical Methods Fisher’s exact test was used for statistical analysis.
Results Sixty-three patients were enrolled in the study (mean age 77 years, range 54 –94). Of the 63 patients, 8 had incomplete follow-up and were excluded from analysis. Of these 8 patients, 4 died before 18 months follow-up, 2 refused surgery after entry into the study, 1 requested to withdraw from the study after having had surgery, and 1 was lost to follow-up. Of the remaining 55 patients, 48 were reviewed by an ophthalmologist and 7 were reviewed by a general practitioner. Both the ES and ES⫹LTS group were similar with respect to age, gender, and eye operated (Table 1) (gender Fisher’s exact test ⫽ 1.000; laterality Fisher’s exact test ⫽ 0.298). In the ES group, 6 patients (21%) had a recurrence of their entropion at or before their 18-month follow-up visit compared with no recurrences seen in the ES⫹LTS group (P ⫽ 0.024). Surgery was performed by a variety of surgeons with differing Table 1. Baseline Characteristics Comparison
Age mean, yrs Male Female Left eye Right eye
ES
ESⴙLTS
77 14 15 13 16
78 13 13 8 18
ES ⫽ everting sutures; ES⫹LTS ⫽ everting sutures with lateral tarsal strip.
353
Ophthalmology Volume 117, Number 2, February 2010 Table 2. Comparison of Surgeon Grades Operating on Treatment Groups
Junior doctor Registrar Staff grade Fellow Consultant Total
ES
ESⴙLTS
6 4 2 13 4 29
5 6 1 11 3 26
ES ⫽ everting sutures; ES⫹LTS ⫽ everting sutures with lateral tarsal strip.
levels of experience, in similar proportions between the 2 treatment groups (Table 2). There was no statistically significant difference between the mean horizontal lid laxity (HLL) in the ES and ES⫹LTS groups (9.6 vs 9.5 mm, respectively). There was, however, a trend for the patients in the failed ES group to have a higher HLL (10.8 mm) than the group as a whole, although this was not statistically significant. Two patients from the ES group developed a suture-related granuloma that was treated without entropion recurrence. No cases of ectropion occurred in either treatment group. Figure 1 shows a preoperative and 3 weeks postoperative photograph of a patient who underwent ES⫹LTS surgery.
Our study confirms the findings of Barnes et al6 in a comparative randomized trial under the supervision of 1 principal surgeon with a uniform surgical technique performed by a number of surgeons with differing levels of experience, which may better reflect the comparative efficacy of these 2 procedures. The clinically and statistically significant higher success rate of ES⫹LTS compared with ES alone highlights the importance of addressing HLL when treating patients with entropion. Fixation of the tarsal strip to the orbital margin in the LTS procedure also prevents rotation of the lower lid at its lateral insertion, and this may further aid in preventing recurrent entropion. Although the 2 groups were comparable with respect to HLL, the average HLL was slightly higher in patients in the ES group who had a recurrence of their entropion, but the difference did not reach statistical significance. On the basis of our findings, it would be reasonable to address HLL when surgically managing entropion to reduce the risk of entropion recurrence. A larger study could better define the role of addressing HLL in the success or failure of entropion surgery. Furthermore, it would be useful to further investigate whether ES failures are more common in patients presenting with greater degrees of HLL. This information may suggest that one could perform ES for patients with a smaller degree of HLL and ES⫹LTS for those presenting with greater HLL.
Discussion Conclusions To the best of our knowledge, this is the first randomized comparative study comparing the relative efficacy of treating involutional entropion with ES alone or with ES⫹LTS. Everting sutures alone have been shown to be an effective, simple, and safe treatment for involutional entropion with a long-term recurrence rate of 15% (mean follow-up 31 months).7 The ES⫹LTS procedure has a variable success rate recorded in the literature. Barnes et al6 assessed ES⫹LTS and found a recurrence rate of 2% (mean follow-up 18 months), whereas Ho et al13 found a 9.4% recurrence rate when ES⫹LTS was performed as a primary procedure (at a mean follow-up of 2 years.)13 It is unclear why Ho et al found a higher recurrence rate, although differences in surgical technique or patient population may have been contributing factors. The number of sutures used for ES also was not stated.
Our study provides strong evidence that ES⫹LTS is more effective than ES alone for correcting involutional entropion. Addressing both the horizontal and the vertical lower eyelid laxity in patients with involutional entropion seems to have a more long-lasting effect on maintaining lower eyelid stability; however, for patients in whom performing LTS surgery is not practical, ES alone may be indicated because of its immediate effect, simplicity to perform, and relatively high success rate. The ES⫹LTS procedure should, however, be performed whenever possible to optimize the long-term treatment for involutional entropion. We think that ES⫹LTS is a quicker, technically less-demanding primary procedure with a reasonable success rate compared with formal inferior retractor placation ⫹ LTS. Failure of ES⫹LTS then allows formal inferior retractor placation to
Figure 1. Preoperative and 3 weeks postoperative photographs of a patient who underwent ES⫹LTS surgery.
354
Scheepers et al 䡠 EVS Compared with EVS⫹LTS be performed. Lateral tarsal strip alone was not investigated in our study, and determining whether LTS alone is as effective as ES⫹LTS is warranted in future randomized prospective studies. The recurrence rate in ES⫹LTS in our study was 0%, and previous studies of LTS alone had a recurrence rate of 14% to 22%,11,14 suggesting that the combined procedure may be more efficacious.
References 1. Collin JR, Rathbun JE. Involutional entropion: a review with evaluation of a procedure. Arch Ophthalmol 1978;96: 1058 – 64. 2. Jones LT. The anatomy of the lower eyelid and its relation to the cause and cure of entropion. Am J Ophthalmol 1960;49: 29 –36. 3. Dalgleish R, Smith JL. Mechanics and histology of senile entropion. Br J Ophthalmol 1966;50:79 –91. 4. Dryden RM, Leibsohn J, Wobig J. Senile entropion: pathogenesis and treatment. Arch Ophthalmol 1978;96:1883–5. 5. Steel DH, Hoh HB, Harrad RA, Collins CR. Botulinum toxin for the temporary treatment of involutional lower lid entropion: a clinical and morphological study. Eye 1997;11:472–5.
6. Barnes JA, Bunce C, Olver JM. Simple effective surgery for involutional entropion suitable for the general ophthalmologist. Ophthalmology 2006;113:92– 6. 7. Wright M, Bell D, Scott C, Leatherbarrow B. Everting suture correction of lower lid involutional entropion. Br J Ophthalmol 1999;83:1060 –3. 8. Olver JM. Surgical tips on the lateral tarsal strip. Eye 1998; 12:1007–12. 9. Quickert MH, Rathbun JE. Suture repair of entropion. Arch Ophthalmol 1971;85:304 –5. 10. Meadows AE, Reck AC, Gaston H, Tyers AG. Everting sutures in involutional entropion. Orbit 1999;18:177– 81. 11. Olver JM, Barnes JA. Effective small-incision surgery for involutional lower eyelid entropion. Ophthalmology 2000; 107:1982– 8. 12. Olver JM, Sathia PJ, Wright M. Lower eyelid medial canthal tendon laxity grading: an interobserver study of normal subjects. Ophthalmology 2001;108:2321–5. 13. Ho SF, Pherwani A, Elsherbiny SM, Reuser T. Lateral tarsal strip and Quickert sutures for lower eyelid entropion. Ophthal Plast Reconstr Surg 2005;21:345– 8. 14. Rougraff PM, Tse DT, Johnson TE, Feuer W. Involutional entropion repair with fornix sutures and lateral tarsal strip procedure. Ophthal Plast Reconstr Surg 2001;17:281–7.
Footnotes and Financial Disclosures Originally received: October 5, 2008. Final revision: June 14, 2009. Accepted: June 23, 2009. Available online: October 28, 2009. 1 2
3
Manuscript no. 2008-1188.
Charing Cross and Western Eye Hospitals, London, United Kingdom.
Department of Ophthalmology, University of Malaya, Kuala Lumpur, Malaysia.
Moorfields Eye Hospital, London, United Kingdom. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Correspondence: Jane Olver, FRCS, FRCOphth, Oculoplastic and Orbital Service, Western Eye Hospital, Imperial Healthcare NHS Trust, Marylebone Road, London, NW1 5YE, United Kingdom. E-mail: [email protected].
355
Involutional entropion is a common lower lid malposition. Without treatment the condition can cause ocular discomfort, epiphora, and corneal ulceration with the potential development of microbial keratitis and a subsequent risk of visual loss. The underlying pathogenesis of involutional entropion is multifactorial. The factors thought to be involved include horizontal eyelid laxity, vertical lower lid laxity secondary to inferior retractor laxity and dehiscence, migration of the preseptal orbicularis muscle over the pretarsal orbicularis muscle, and appositional pressure during forced eyelid closure over a shrunken tarsal plate.1– 4 Conservative treatment is likely to provide only temporary relief and includes the use of topical lubricants, taping of the lower lid, or botulinum toxin chemo-denervation.5 Surgery is, however, the mainstay of treatment and addresses the underlying anatomic pathology of the condition.6 Many surgical procedures with varying long-term success rates have been described for the treatment of entropion.1,4,6 –11 The use of everting sutures (ES) alone is advocated by many surgeons because of the advantages of being quick and relatively simple to perform, and anticoagulation treatment does not need to be omitted compared with more invasive eyelid procedures.7 Placement of ES rotates the eyelid mar-
352
© 2010 by the American Academy of Ophthalmology Published by Elsevier Inc.
gin anteriorly and tightens the inferior retractors. However, it has not been determined whether a horizontal eyelid tightening procedure in conjunction with ES significantly improves the success rate of treating involutional entropion. We have therefore conducted a prospective, randomized comparative trial assessing the relative efficacy of treating involutional entropion with ES and horizontal eyelid shortening using the lateral tarsal strip (LTS) procedure (ES⫹LTS) compared with ES alone. To the best of our knowledge, this is the first comparative randomized trial to evaluate the success rates of 2 entropioncorrecting procedures.
Materials and Methods From statistical analysis, the sample size calculation required 110 patients per treatment group to have 90% power to detect a significant difference between the 15% entropion recurrence rate reported by Wright et al7 for ES and the 2% entropion recurrence rate reported by Barnes et al6 for ES⫹LTS. We therefore designed a multicenter trial and set out to recruit in excess of 110 patients from 5 treatment centers, but lack of research staff resulted in 2 hospitals withdrawing from the study before commencing patient ISSN 0161-6420/10/$–see front matter doi:10.1016/j.ophtha.2009.06.056
Scheepers et al 䡠 EVS Compared with EVS⫹LTS enrollment. We were only able to recruit 63 patients after an 18-month time period, after which we decided to perform statistical analysis on the available data. Patients were recruited independently from other studies. Exclusion criteria included a history of previous lower lid surgery, patients with grade 4 medial canthal tendon laxity by the lateral distraction test (grade 4 laxity is where the lower lid punctum can be pulled laterally to the center of the pupil),12 and excessive horizontal eyelid laxity secondary to floppy eyelid syndrome. If the horizontal eyelid laxity exceeded 13 mm, the patient was excluded. Horizontal eyelid laxity was determined using the pinch test. This test is performed by grasping the lower lid skin over the central aspect of the lower lid tarsal plate and pulling the lower lid away from the globe. The distance between the globe and the posterior aspect of the lower lid is then measured and recorded as the horizontal eyelid laxity measurement.12 Institutional ethics committee approval was obtained, and patients were recruited with informed consent. Eligible patients were randomized to ES or ES⫹LTS by drawing an envelope from a box that contained 1 of the 2 randomization assignments, with half the patients randomized to ES and the other half to ES⫹LTS. For patients with bilateral disease, only the first eyelid operated on was entered into the study.
Surgical Methods Surgery was performed under local anesthesia in all patients. Local anesthesia included tetracaine eye drops in the conjunctival sac and subcutaneous infiltration of the lower eyelid with half-and-half by volume of lidocaine 2% with 1:200 000 epinephrine and bupivacaine 0.5%. For ES⫹LTS, the lateral canthus was also infiltrated down to the periosteum along with the lateral third of the upper eyelid.
Everting Sutures Technique Four ES (6-0 double-armed polyglactin) were inserted through the conjunctiva deep within the inferior fornix. The sutures were equally spaced within the lateral two thirds of the lower lid, as has been described.7,9,10 Each suture end is passed approximately 2 to 3 mm next to its fellow. The sutures emerge through the skin approximately 2 to 4 mm below the lash line where their ends are initially secured with bulldog clips (small clips used for holding suture thread) before being tied firmly and trimmed once all the sutures are placed. The aim is to induce a slight overcorrection of the entropion. Sutures are not placed in the medial one third of the lower lid where they may cause a punctal ectropion and epiphora. The sutures are left in situ to bury and create scarring as they dissolve, helping to create an adhesion between the tightened inferior retractors and inferior tarsal plate.
Lateral Tarsal Strip and Everting Sutures A lateral canthotomy and inferior cantholysis are initially performed. A “tarsal strip” is fashioned from the lateral lower eyelid by stripping the superior mucocutaneous junction tissue, debriding conjunctival epithelium posteriorly, excising the anterior lamella, and making a linear incision inferiorly to create a “tendon” of tarsal plate.8 The length of the fashioned tendon is determined by assessing the desired tension required to tighten the lower eyelid. After the creation of the LTS, the ES are performed in the fashion described previously, with the sutures being placed having taken into account the new lateral extent of the lower eyelid. The tarsal strip is attached to the internal lateral orbital rim with a double-armed 5-0 polyglactin suture by creating a slip knot at the tendon and passing the 2 suture ends through the internal orbital
portion of the lateral orbital rim periosteum.8 The aim is to slightly overcorrect the height of the eyelid by placing the suture slightly more superiorly than the lateral canthal angle while maintaining a posterior vector of tension. Just before tying this suture, lateral canthal reformation is achieved with a single buried 6-0 polyglactin suture. Deep buried 6-0 polyglactin suture is used to close the lateral canthal orbicularis muscle followed by skin closure with interrupted 7-0 polyglactin suture.
Postoperative Care Chloramphenicol ointment was instilled in the inferior conjunctival fornix and suture sites for both ES and ES⫹LTS, and paraffin gauze and a double eye pad were used for a firm dressing for 24 hours for ES⫹LTS. After both procedures, patients were asked to instil chloramphenicol 0.5% eye drops 4 times per day for 3 weeks according to standard departmental protocol for eyelid surgery. Patients were asked to take care not to pull on their lower lid when instilling the drops because it could increase the risk of dehiscence. The first postoperative review in the outpatient clinic was 3 weeks after surgery. Patients were then reviewed again at 6, 12, and 18 months postoperatively by an unmasked medical practitioner. All patients were followed up for a minimum of 18 months to ensure that late failures were detected.11 Successful surgery was defined as resolution of entropion confirmed with a tetracaine provocation test in the presence of a normal eyelid position.12 Surgical failure was defined as a recurrence of entropion at rest or after the tetracaine provocation test at or before the 18-month follow-up visit, or secondary ectropion that persisted for more than 2 months after surgery.
Statistical Methods Fisher’s exact test was used for statistical analysis.
Results Sixty-three patients were enrolled in the study (mean age 77 years, range 54 –94). Of the 63 patients, 8 had incomplete follow-up and were excluded from analysis. Of these 8 patients, 4 died before 18 months follow-up, 2 refused surgery after entry into the study, 1 requested to withdraw from the study after having had surgery, and 1 was lost to follow-up. Of the remaining 55 patients, 48 were reviewed by an ophthalmologist and 7 were reviewed by a general practitioner. Both the ES and ES⫹LTS group were similar with respect to age, gender, and eye operated (Table 1) (gender Fisher’s exact test ⫽ 1.000; laterality Fisher’s exact test ⫽ 0.298). In the ES group, 6 patients (21%) had a recurrence of their entropion at or before their 18-month follow-up visit compared with no recurrences seen in the ES⫹LTS group (P ⫽ 0.024). Surgery was performed by a variety of surgeons with differing Table 1. Baseline Characteristics Comparison
Age mean, yrs Male Female Left eye Right eye
ES
ESⴙLTS
77 14 15 13 16
78 13 13 8 18
ES ⫽ everting sutures; ES⫹LTS ⫽ everting sutures with lateral tarsal strip.
353
Ophthalmology Volume 117, Number 2, February 2010 Table 2. Comparison of Surgeon Grades Operating on Treatment Groups
Junior doctor Registrar Staff grade Fellow Consultant Total
ES
ESⴙLTS
6 4 2 13 4 29
5 6 1 11 3 26
ES ⫽ everting sutures; ES⫹LTS ⫽ everting sutures with lateral tarsal strip.
levels of experience, in similar proportions between the 2 treatment groups (Table 2). There was no statistically significant difference between the mean horizontal lid laxity (HLL) in the ES and ES⫹LTS groups (9.6 vs 9.5 mm, respectively). There was, however, a trend for the patients in the failed ES group to have a higher HLL (10.8 mm) than the group as a whole, although this was not statistically significant. Two patients from the ES group developed a suture-related granuloma that was treated without entropion recurrence. No cases of ectropion occurred in either treatment group. Figure 1 shows a preoperative and 3 weeks postoperative photograph of a patient who underwent ES⫹LTS surgery.
Our study confirms the findings of Barnes et al6 in a comparative randomized trial under the supervision of 1 principal surgeon with a uniform surgical technique performed by a number of surgeons with differing levels of experience, which may better reflect the comparative efficacy of these 2 procedures. The clinically and statistically significant higher success rate of ES⫹LTS compared with ES alone highlights the importance of addressing HLL when treating patients with entropion. Fixation of the tarsal strip to the orbital margin in the LTS procedure also prevents rotation of the lower lid at its lateral insertion, and this may further aid in preventing recurrent entropion. Although the 2 groups were comparable with respect to HLL, the average HLL was slightly higher in patients in the ES group who had a recurrence of their entropion, but the difference did not reach statistical significance. On the basis of our findings, it would be reasonable to address HLL when surgically managing entropion to reduce the risk of entropion recurrence. A larger study could better define the role of addressing HLL in the success or failure of entropion surgery. Furthermore, it would be useful to further investigate whether ES failures are more common in patients presenting with greater degrees of HLL. This information may suggest that one could perform ES for patients with a smaller degree of HLL and ES⫹LTS for those presenting with greater HLL.
Discussion Conclusions To the best of our knowledge, this is the first randomized comparative study comparing the relative efficacy of treating involutional entropion with ES alone or with ES⫹LTS. Everting sutures alone have been shown to be an effective, simple, and safe treatment for involutional entropion with a long-term recurrence rate of 15% (mean follow-up 31 months).7 The ES⫹LTS procedure has a variable success rate recorded in the literature. Barnes et al6 assessed ES⫹LTS and found a recurrence rate of 2% (mean follow-up 18 months), whereas Ho et al13 found a 9.4% recurrence rate when ES⫹LTS was performed as a primary procedure (at a mean follow-up of 2 years.)13 It is unclear why Ho et al found a higher recurrence rate, although differences in surgical technique or patient population may have been contributing factors. The number of sutures used for ES also was not stated.
Our study provides strong evidence that ES⫹LTS is more effective than ES alone for correcting involutional entropion. Addressing both the horizontal and the vertical lower eyelid laxity in patients with involutional entropion seems to have a more long-lasting effect on maintaining lower eyelid stability; however, for patients in whom performing LTS surgery is not practical, ES alone may be indicated because of its immediate effect, simplicity to perform, and relatively high success rate. The ES⫹LTS procedure should, however, be performed whenever possible to optimize the long-term treatment for involutional entropion. We think that ES⫹LTS is a quicker, technically less-demanding primary procedure with a reasonable success rate compared with formal inferior retractor placation ⫹ LTS. Failure of ES⫹LTS then allows formal inferior retractor placation to
Figure 1. Preoperative and 3 weeks postoperative photographs of a patient who underwent ES⫹LTS surgery.
354
Scheepers et al 䡠 EVS Compared with EVS⫹LTS be performed. Lateral tarsal strip alone was not investigated in our study, and determining whether LTS alone is as effective as ES⫹LTS is warranted in future randomized prospective studies. The recurrence rate in ES⫹LTS in our study was 0%, and previous studies of LTS alone had a recurrence rate of 14% to 22%,11,14 suggesting that the combined procedure may be more efficacious.
References 1. Collin JR, Rathbun JE. Involutional entropion: a review with evaluation of a procedure. Arch Ophthalmol 1978;96: 1058 – 64. 2. Jones LT. The anatomy of the lower eyelid and its relation to the cause and cure of entropion. Am J Ophthalmol 1960;49: 29 –36. 3. Dalgleish R, Smith JL. Mechanics and histology of senile entropion. Br J Ophthalmol 1966;50:79 –91. 4. Dryden RM, Leibsohn J, Wobig J. Senile entropion: pathogenesis and treatment. Arch Ophthalmol 1978;96:1883–5. 5. Steel DH, Hoh HB, Harrad RA, Collins CR. Botulinum toxin for the temporary treatment of involutional lower lid entropion: a clinical and morphological study. Eye 1997;11:472–5.
6. Barnes JA, Bunce C, Olver JM. Simple effective surgery for involutional entropion suitable for the general ophthalmologist. Ophthalmology 2006;113:92– 6. 7. Wright M, Bell D, Scott C, Leatherbarrow B. Everting suture correction of lower lid involutional entropion. Br J Ophthalmol 1999;83:1060 –3. 8. Olver JM. Surgical tips on the lateral tarsal strip. Eye 1998; 12:1007–12. 9. Quickert MH, Rathbun JE. Suture repair of entropion. Arch Ophthalmol 1971;85:304 –5. 10. Meadows AE, Reck AC, Gaston H, Tyers AG. Everting sutures in involutional entropion. Orbit 1999;18:177– 81. 11. Olver JM, Barnes JA. Effective small-incision surgery for involutional lower eyelid entropion. Ophthalmology 2000; 107:1982– 8. 12. Olver JM, Sathia PJ, Wright M. Lower eyelid medial canthal tendon laxity grading: an interobserver study of normal subjects. Ophthalmology 2001;108:2321–5. 13. Ho SF, Pherwani A, Elsherbiny SM, Reuser T. Lateral tarsal strip and Quickert sutures for lower eyelid entropion. Ophthal Plast Reconstr Surg 2005;21:345– 8. 14. Rougraff PM, Tse DT, Johnson TE, Feuer W. Involutional entropion repair with fornix sutures and lateral tarsal strip procedure. Ophthal Plast Reconstr Surg 2001;17:281–7.
Footnotes and Financial Disclosures Originally received: October 5, 2008. Final revision: June 14, 2009. Accepted: June 23, 2009. Available online: October 28, 2009. 1 2
3
Manuscript no. 2008-1188.
Charing Cross and Western Eye Hospitals, London, United Kingdom.
Department of Ophthalmology, University of Malaya, Kuala Lumpur, Malaysia.
Moorfields Eye Hospital, London, United Kingdom. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Correspondence: Jane Olver, FRCS, FRCOphth, Oculoplastic and Orbital Service, Western Eye Hospital, Imperial Healthcare NHS Trust, Marylebone Road, London, NW1 5YE, United Kingdom. E-mail: [email protected].
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