Purpose
To evaluate the complications of cosmetic wide conjunctivectomy and postoperative topical mitomycin C application with or without bevacizumab injection.
Design
Cross-sectional cohort study.
Methods
Medical records of 1713 consecutive subjects who received cosmetic wide conjunctivectomy plus postoperative topical mitomycin C by a single surgeon at a single center with or without bevacizumab injection from November 2007 to May 2010 were reviewed. A telephone interview was conducted with 557 of the subjects who could be contacted and agreed to participate in the study. Complications, recurrences, and patient satisfaction were the main outcome measures.
Results
A total of 1713 consecutive patients underwent cosmetic wide conjunctivectomy to treat conjunctival hyperemia. Ocular diagnoses in the medical records at the time of surgery included hyperemia (8.8%), pterygium (14.0%), dry eye (3.5%), pinguecula (1.5%), and conjunctival disorder (23.3%). For the remaining 48.9% of subjects, the diagnosis was not mentioned, or the surgical procedure was for cosmetic purposes. Patients were followed for a mean of 10.9 months (range, 0-30.3 months). The overall complication rate was 82.9%, of which 55.6% were considered severe (fibrovascular conjunctival tissue proliferation, 43.8%; scleral thinning, 4.4%; scleral thinning with calcified plaques, 6.2%; intraocular pressure elevation, 13.1%; diplopia, 3.6%; and recurrence of hyperemic conjunctiva, 28.1%).
Conclusions
Cosmetic wide conjunctivectomy plus postoperative topical mitomycin C with or without bevacizumab injection has a high rate of complications and reoperations.
Regional conjunctivectomy with postoperative mitomycin C has been reported as a new surgical treatment for chronic conjunctival hyperemia. After wide excision of the medial and/or lateral conjunctiva and Tenon capsule, topical 0.02% mitomycin C is used 4 times daily for 2 to 5 days postoperatively. The goal of the procedure is to create a more cosmetically acceptable, whitened conjunctiva. Recently, the author of the cited publication has added the injection of bevacizumab during the procedure to improve outcomes and reduce the likelihood of recurrences.
Regional conjunctivectomy has become a popular cosmetic procedure in East Asia. A single clinic in South Korea has performed the procedure on more than 1800 patients. An eye-whitening procedure termed I-BRITE, which involves surgical intervention in conjunction with the use of mitomycin C, is also being offered in the United States ( www.boxerwachler.com/whiteeyes ). Although a high patient satisfaction rate without the development of permanent complications has obeen reported for regional conjunctivectomy with postoperative mitomycin C, others have observed a high rate of complications in patients who have undergone this procedure. In fact, some ophthalmologists have expressed concern about the procedure, focusing on the costs and potential risks of the use of an antimetabolite (mitomycin C) combined with an extensive conjunctival excision for cosmetic purposes.
On March 4, 2011, the Korean Ministry of Health & Welfare issued an order to discontinue the procedure under Article 59 of the Medical Service Act. Litigation continues between patients who claim damages from complications of the procedure. The practitioner has also filed litigation against the Ministry of Health & Welfare, demanding cancellation of the order. As of this date, the order remains in force.
The current study was undertaken to provide a comprehensive, unbiased evaluation of the complication rate and patient satisfaction of cosmetic regional conjunctivectomy with postoperative mitomycin C with or without bevacizumab injection and to provide accurate information to practitioners, as well as to the public.
Methods
Cosmetic eye-whitening surgery was assessed through a retrospective review of medical records, telephone survey, and systematic review of the relevant medical literature. This study was approved by the institutional review board of the Korean National Evidence-Based Healthcare Collaborating Agency (NECAIRB10-005) and adhered to the tenets of the Declaration of Helsinki.
Patient Medical Records and Follow-Up Investigation
This study was carried out under the direction of The Committee for New Health Technology Assessment, formed by the Ministry of Health & Welfare in accordance with Article 54 of the Medical Services Act, to review the safety and efficacy of new health technologies. The committee members comprise 20 professionals in the field of health and medicine, including experts in internal medicine, external medicine, dentistry, Korean Traditional Medicine, and other fields. Medical records were obtained according to Article 61, Section 1 of the Medical Services Act, which allows the Minister of Health & Welfare to review medical records and to obtain testimony from relevant persons to obtain/confirm facts related to medical procedures when concern has been raised about their safety and efficacy.
A committee composed of 5 ophthalmologists, a family medicine doctor, and a plastic surgeon was appointed by the South Korea Ministry of Health & Welfare to oversee the investigation. A data collection form was created by the committee to be used during telephone interviews and medical record reviews ( Supplementary Figure , available at AJO.com ). Four reviewers independently extracted data from the medical records. Disagreements were resolved by discussion among the reviewers until consensus was obtained. A total of 557 of the 1713 subjects (32%) who underwent the procedure could be reached by telephone and agreed to be interviewed by trained researchers using the data collection form. Multiple responses for each question were allowed. Thus, percentages of responses may total more than 100%.
On the basis of discussions with the Committee for New Health Technology and its subcommittee, eye-whitening surgery was assessed using the complication and reoperation rates. Many complications that had an overlapping spectrum were defined as follows by the subcommittee and The Korean Ophthalmological Society was consulted to confirm a diagnosis: severe fibrous proliferation on conjunctiva: excessive fibrotic response after surgery; calcified sclera: deposition of calcium to dead sclera; scleromalacia: melting or separation of devitalized sclera tissue; sclera necrosis: inflammation in association with devitalized sclera; sclera ischemia: absence of nutrition-providing blood vessels present in sclera with no signs of melting; scleritis: inflammation of the sclera without necrosis; symblepharon: attachment of the bulbar conjunctiva to tarsal conjunctiva; subconjunctival adhesion: attachment of tissues without symblepharon; muscle adhesion: adhesion of muscle and its surrounding tissues without symblepharon. The following complications were considered severe: fibrous proliferation, calcification, scleromalacia, scleral necrosis, scleral ischemia, scleritis, diplopia, strabismus, intraocular pressure elevation, glaucoma, cataract, symblepharon, and muscle adhesion to the remaining conjunctiva. The number of reoperations for each patient was defined as the maximum number of procedures carried out in 1 quadrant of the conjunctiva.
Patient satisfaction was evaluated using a 5-point subjective satisfaction scale, measuring satisfaction with eye whitening and improvement in dry eye according to medical records or telephone interviews.
SPSS statistical software (version 20.0; SPSS Inc, Chicago, Illinois, USA) was used for data analysis.
Results
Medical Record Reviews
The medical records of 1818 medical patients who were reported to have undergone regional conjunctivectomy by a single surgeon at a single clinic in Korea from November 23, 2007 to May 20, 2010 were reviewed. A total of 105 patients were discovered not to have received eye-whitening surgery, so they were excluded from further consideration. The remaining 1713 patients (94.2%) were the subjects for this study. The records were defined as complete if the questions in the data collection form (Supplementary Figure) were all answered. Among the 1713 patients, records were complete for 1351 of the subjects (78.9%). Of the 1713 patients, 594 were male (34.7%) and 1119 were female (65.3%). The mean age of the patients was 39.2 years (range, 22-77 years) and the mean follow-up period was 325.5 days (range, 0-908 days). The recorded indications for surgery were conjunctival hyperemia in 151 patients (8.8%), pterygium in 240 patients (14.0%), dry eyes in 60 patients (3.5%), pingecula in 25 patients (1.5%), unspecified conjunctival disorders in 399 patients (23.3%), requested by the patient in 118 patients (6.9%), and not recorded in 720 patients (42.0%). Preexisting conditions that were recorded include pterygium (9.1%, 156/1713), glaucoma (0.7%, 12/1713), chronic hyperemic conjunctiva (5.3%, 91/1713), and dry eye (2.8%, 48/1713). The remainder of the patients (82.1%, 1406/1713) had no underlying ophthalmic disease documented in the medical record.
The mean number of eye-whitening surgical procedures was 1.4 per patient (range, 1-7). Surgery was performed once on 1225 patients (71.5%), twice on 332 patients (19.4%), 3 times on 102 patients (6.0%), 4 times on 40 patients (2.3%), and 5 or more times on 3 patients (0.2%). The number of procedures performed on 10 patients (0.6%) was uncertain.
After wide excision of the conjunctiva, subconjunctival injection of bevacizumab 0.03-0.1 mL (practitioner’s opinion) was carried out on the remaining conjunctival tissue intraoperatively on 350 patients (20.4%) after September 2009. Bevacizumab was also injected postoperatively 1 to 5 times in 63.4% (222/350) of the patients and was used up to a maximum of 25 times in the remaining patients.
Complications were documented in the medical records an average of 88.2 days after surgery (range, 0-730 days) in 1420 patients (82.9%), with 952 patients (55.6%) demonstrating severe complications ( Table 1 , Figure ). Surgical intervention was required for the management of postoperative complications in 483 patients (34.0%). The indications and frequency for secondary surgical procedures are shown in Table 2 .
| Severe Complications | Patient N (%) | Other Complications | Patient N (%) |
|---|---|---|---|
| Fibroproliferation | 751 (43.8) | Dry eyes | 555 (32.4) |
| Scleromalacia | 75 (4.4) | Ocular hyperemia | 530 (30.9) |
| Scleral necrosis | 1 (0.1) | Conjunctival granuloma | 326 (19.0) |
| Scleritis | 3 (0.2) | Irritation | 163 (9.5) |
| Sclera calcification | 107 (6.2) | Discomfort in eye a | 197 (11.5) |
| Diplopia | 61 (3.6) | Pain | 118 (6.9) |
| Strabismus | 26 (1.5) | Conjunctivitis | 32 (1.9) |
| IOP elevation | 225 (13.1) | Decreased visual acuity | 72 (4.2) |
| Glaucoma | 14 (0.8) | Headache | 26 (1.5) |
| Cataract | 4 (0.2) | Increased eye secretions | 304 (17.7) |
| Symblepharon | 1 (0.1) | Subconjunctival hemorrhage | 118 (6.9) |
| Muscle adhesion | 1 (0.1) | Blister | 16 (0.9) |
| Adhesion | 32 (1.9) | Inflammation | 12 (0.7) |
| Conjunctival pigmentation | 108 (6.3) | Corneal edema | 7 (0.4) |
| Keratitis | 21 (1.2) | Floaters | 6 (0.4) |
| Other (edema, epiphora, etc) | 187 (10.9) |
| Indication for Reoperation | Patient N (%) |
|---|---|
| Fibroproliferation | 291 (17.0) |
| Ocular hyperemia | 50 (3.9) |
| Dry eye | 3 (0.2) |
| Calcification | 36 (2.1) |
| Strabismus, diplopia, and adhesion | 10 (0.6) |
| No regeneration of epithelial cells | 1 (0.1) |
| Scleromalacia | 8 (0.5) |
| Retinal degeneration | 1 (0.1) |
| Other (desired by patient, dissatisfaction, etc) | 22 (1.3) |
| Reason not mentioned | 153 (8.9) |
A total of 5714 quadrants underwent cosmetic eye-whitening surgery, and 945 quadrants (16.5%) underwent reoperation for hyperemia attributable to conjunctival tissue regeneration.
Patient satisfaction was documented to be 96.4% in the medical records of 411 patients by the surgeon at the last outpatient visit (mean, 2.46 months postoperatively). We were not able to assess the satisfaction rate of the remaining 1302 patients, as the level of satisfaction was not documented in the medical record.
Follow-Up Investigation by Telephone
In an attempt to determine the satisfaction rate for regional conjunctivectomy, we attempted to contact all 1713 patients by telephone. Of these patients, 557 (32.5%) were contacted and agreed to participate in the telephone survey follow-up investigation. The remainder (67.5%) either had changed their telephone number (21.4%), did not receive our calls (30.2%), or declined to participate in our survey (15.9%).
Of the 557 patients participating in the telephone survey, 209 (37.5%) were male and 348 (62.5%) were female. The mean age was 29.9 years (range, 20-77 years). Of these patients, 323 (58.0%) had no underlying ophthalmic disease. Pterygium (60 patients, 10.8%), pinguecula (8 patients, 1.4%), chronic conjunctival hyperemia (31 patients, 5.6%), dry eye (100 patients, 18.0%), glaucoma (3 patients, 0.5%), cataract (5 patients, 0.9%), strabismus (6 patients, 1.1%), and conjunctivitis (24 patients, 4.3%) were reported by the remaining patients. Twenty-three patients (4.1%) had previously undergone surgery for pterygium, and 2 patients (0.4%) had previously undergone eye-whitening surgery at a different hospital.
The indications reported for surgery in subjects available for telephone interview were conjunctival hyperemia (446 patients, 80.1%), dry eyes (139 patients, 25.0%), and pterygium (64 patients, 11.5%).
The average number of eye-whitening surgeries conducted on the 557 patients who agreed to the telephone survey was 1.6 (range, 1-6). Surgery was performed once on 355 patients (63.7%), twice on 125 patients (22.4%), 3 times on 45 patients (8.1%), 4 times on 18 patients (3.2%), and 5 times or more on 9 patients (1.6%). The exact number of surgery was not recorded in the medical records of 5 patients (0.9%).
A total of 387 patients (69.5%) whom we surveyed by telephone experienced postoperative complications ( Table 3 ), with 33.6% (187/557) of the patients experiencing major complications. The complication rate for regional conjunctivectomy with bevacizumab injection was 61.8%, and the complication rate for surgery without bevacizumab injection was 70.6% ( P = .001, χ 2 test). The complications arose at various time points, from immediately after surgery to 2 years postoperatively. Complications were reported most frequently at 4 months after surgery (49.6%), and 82.1% of the complications occurred within 1.5 years after surgery.
| Complication | Patient N (%) |
|---|---|
| Fibroproliferation | 154 (39.8) |
| Scleromalacia | 4 (0.5) |
| Scleral necrosis | 1 (0.3) |
| Calcification | 18 (4.7) |
| Strabismus | 12 (3.1) |
| IOP elevation | 6 (1.6) |
| Corneal ulcer | 1 (0.3) |
| Dry eyes | 29 (7.5) |
| Irritation | 67 (17.3) |
| Discomfort in eye a | 111 (28.7) |
| Diplopia | 17 (4.4) |
| Glaucoma | 1 (0.3) |
The reoperation rate attributable to postoperative complications was 34.5% (192 of 557 patients). The reasons for reoperations are shown in Table 4 . A total of 1824 quadrants underwent cosmetic eye-whitening surgery and 351 quadrants (19.2%) were reoperated because of conjunctival tissue regeneration.
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