R. Doyle Stulting

Risk factors and prognosis for corneal ectasia after LASIK

PURPOSE To review cases of corneal ectasia after laser in situ keratomileusis (LASIK), identify preoperative risk factors, and evaluate methods and success rates of visual rehabilitation for these cases. DESIGN Retrospective nonrandomized comparative trial. PARTICIPANTS Ten eyes from seven patients identified as developing corneal ectasia after LASIK, 33 previously reported ectasia cases, and two control groups with uneventful LASIK and normal postoperative courses: 100 consecutive cases (first control group), and 100 consecutive cases with high myopia (> 8 diopters [D]) preoperatively (second control group). METHODS Retrospective review of preoperative and postoperative data for each case compared with that of previously reported cases and cases with uneventful postoperative courses. MAIN OUTCOME MEASURES Preoperative refraction, topographic features, residual stromal bed thickness (RSB), time to the development of ectasia, number of enhancements, final best-corrected visual acuity (BCVA), and method of final correction. RESULTS Length of follow-up averaged 23.4 months (range, 6-48 months) after LASIK. Mean time to the development of ectasia averaged 16.3 months (range, 1-45 months). Preoperative refraction averaged -8.69 D compared with -5.37 D for the first control group (P = 0.005). Preoperatively, 88% of ectasia cases met criteria for forme fruste keratoconus, compared with 2% of the first control group (P < 0.0000001) and 4% of the second control group (P = 0.0000001). Seven eyes (70%) had RSB <250 microm, as did 16% of eyes in the first control group and 46% of the second control group. The mean RSB for ectasia cases (222.8 microm) was significantly less than that for the first control group (293.6 micro m, P = 0.0004) and the second control group (256.5 microm; P = 0.04). Seven eyes (70%) had enhancements. Only 10% of eyes lost more than one line of BCVA, and all patients eventually achieved corrected vision of 20/30 or better. One case required penetrating keratoplasty (10%), while all others required rigid gas-permeable contact lenses for correction. CONCLUSIONS Significant risk factors for the development of ectasia after LASIK include high myopia, forme fruste keratoconus, and low RSB. All patients had at least one risk factor other than high myopia, and significant differences remained even when controlling for myopia. Multiple enhancements were common among affected cases, but their causative role remains unknown. We did not identify any patients who developed ectasia without recognizable preoperative risk factors.

Complications of laser in situ keratomileusis for the correction of myopia

OBJECTIVE To determine the incidence and severity of complications from laser in situ keratomileusis (LASIK) for the correction of myopia by experienced and inexperienced surgeons. DESIGN Prospective, observational clinical study. PARTICIPANTS Fourteen surgeons and 1062 eyes of 574 myopic patients who desired surgical correction of myopia ranging from -2.00 to -22.50 diopters (D; mean, -7.57 D) and astigmatism no greater than 4.00 D participated in this study. INTERVENTION Myopia was corrected with LASIK. Astigmatism was corrected with arcuate keratotomy at the same time as the initial procedure or subsequently. MAIN OUTCOME MEASURES Primary outcome measures were change in best spectacle-corrected visual acuity (BSCVA) and the incidence of complications. RESULTS Eyes were followed for a mean of 9.5 months after their last surgical procedure (range, 2 weeks-21 months). Three hundred eighty-one eyes (36%) underwent 468 enhancement procedures 3 months or more after the initial treatment. There were 27 (2.1%) intraoperative and 40 (3.1%) postoperative complications. Laser ablation was not performed during the initial treatment of 17 (1.6%) eyes because of intraoperative complications. Seventy-four eyes gained 2 or more lines of BSCVA, while 50 eyes lost 2 or more lines of BSCVA. Only three eyes lost two or more lines of BSCVA to a level worse than 20/40. One eye with a flap buttonhole (BSCVA 20/50) also had an epiretinal membrane. The second eye (BSCVA 20/60) had a flap buttonhole that may have been related to a previous corneal transplant. The third eye (-22.50 D before surgery) had a rhegmatogenous retinal detachment develop, reducing BSCVA from 20/60 to 20/200. The incidence of intraoperative complications decreased from 3.1% during the first 3 months to 0.7% during the last 9 months of the study (P = 0.02). CONCLUSIONS LASIK is acceptably safe for the correction of myopia. Although complications occur in approximately 5% of cases, these rarely lead to visual loss of more than two Snellen lines and postoperative acuity below 20/40. Flap buttonholes were more likely to cause loss of BSCVA than free or incomplete flaps (P = 0.02); flap buttonholes may be more likely in eyes that have undergone previous surgery. Complication rates can be reduced as the surgical team gains experience.

Risk Factors for Corneal Graft Failure and Rejection in the Collaborative Corneal Transplantation Studies

PURPOSE To evaluate comprehensively the magnitude of suspected risk factors for corneal graft failure from any cause, failure from rejection, and immunologic reaction in patients at high risk for graft failure after corneal transplantation. METHODS The records of the 457 participants in the Collaborative Corneal Transplantation Studies were reviewed. All participants had at least two quadrants of stromal vascularization and/or a history or previous graft rejection. Patients were followed for 2 to 5 years. Characteristics of the patient, study eye, donor, donor-recipient histocompatibility, and surgical procedure were examined for their association with the graft outcomes of failure from any cause, rejection failure, and immunologic reaction. Multivariate survival analysis techniques were used to estimate rates of graft outcome events and to estimate the magnitude of risk factors. RESULTS Many apparent risk factors did not maintain their association with graft outcomes after adjustment for other risk factors. Young recipient age, the number of previous grafts, history of previous anterior segment surgery, preoperative glaucoma, quadrants of anterior synechiae, quadrants of stromal vessels, a primary diagnosis of chemical burn, and blood group ABO incompatibility were among the strongest risk factors identified for graft failure. Donor and corneal preservation characteristics had little influence on graft outcome. CONCLUSIONS Risk of graft failure varies substantially, even within a high-risk population. The number of risk factors present should be considered by the patient and surgeon when contemplating transplantation and planning follow-up.

Acyclovir for the Prevention of Recurrent Herpes Simplex Virus Eye Disease

BACKGROUND Long-term treatment with antiviral agents has been shown to prevent recurrences of genital and orofacial herpes simplex virus (HSV) disease, but it is uncertain whether prophylactic treatment can prevent recurrences of ocular HSV disease. METHODS We randomly assigned 703 immunocompetent patients who had had ocular HSV disease within the preceding year to receive 400 mg of acyclovir or placebo orally twice daily. The study outcomes were the rates of development of ocular or nonocular HSV disease during a 12-month treatment period and a 6-month observation period. RESULTS The cumulative probability of a recurrence of any type of ocular HSV disease during the 12-month treatment period was 19 percent in the acyclovir group and 32 percent in the placebo group (P<0.001). Among the 337 patients with a history of stromal keratitis, the most common serious form of ocular HSV disease, the cumulative probability of recurrent stromal keratitis was 14 percent in the acyclovir group and 28 percent in the placebo group (P=0.005). The cumulative probability of a recurrence of nonocular (primarily orofacial) HSV disease was also lower in the acyclovir group than in the placebo group (19 percent vs. 36 percent, P<0.001). There was no rebound in the rate of HSV disease in the six months after treatment with acyclovir was stopped. CONCLUSIONS After the resolution of ocular HSV disease, 12 months of treatment with acyclovir reduces the rate of recurrent ocular HSV disease and orofacial HSV disease. Long-term antiviral prophylaxis is most important for patients with a history of HSV stromal keratitis, since it can prevent additional episodes and potential loss of vision.

Keratoconus and Corneal Ectasia After LASIK

From Gordon Binder Weiss Vision Institute, San Diego, Calif (Binder); Minnesota Eye Consultants, Minneapolis, Minn (Lindstrom); Emory University, Atlanta, Ga (Stulting); Ophthalmic Consultants of Long Island, Rockville Centre, NY (Donnenfeld); Tufts New England Medical Center, Boston, Mass (Wu); Wilmer Ophthalmological Institute, Johns Hopkins University School of Medicine, Baltimore, Md (McDonnell); and Cornea Genetic Eye Institute, Cedars Sinai Medical Center, Los Angeles, Calif (Rabinowitz).

Dissatisfaction after multifocal intraocular lens implantation

PURPOSE: To analyze the reasons for patient dissatisfaction after phacoemulsification with multifocal intraocular lens (IOL) implantation and the outcomes after intervention. SETTING: Emory Eye Center, Atlanta, Georgia, USA. METHODS: This retrospective review comprised eyes of patients dissatisfied with visual outcomes after multifocal IOL implantation. Outcomes analyzed included type of visual complaint, treatment modality for each complaint, and degree of clinical improvement after intervention. RESULTS: Thirty‐two patients (43 eyes) reported unwanted visual symptoms after multifocal IOL implantation, including in 28 eyes (65%) with an AcrySof ReSTOR IOL and 15 (35%) with a ReZoom IOL. Thirty patients (41 eyes) reported blurred vision, 15 (18 eyes) reported photic phenomena, and 13 (16 eyes) reported both. Causes of blurred vision included ametropia (12 eyes, 29%), dry eye syndrome (6 eyes, 15%), posterior capsule opacification (PCO) (22 eyes, 54%), and unexplained etiology (1 eye, 2%). Causes of photic phenomena included IOL decentration (2 eyes, 12%), retained lens fragment (1 eye, 6%), PCO (12 eyes, 66%), dry‐eye syndrome (1 eye, 2%), and unexplained etiology (2 eyes, 11%). Photic phenomena attributed to PCO also caused blurred vision. Thirty‐five eyes (81%) had improvement with conservative treatment. Five eyes (12%) did not have improvement despite treatment combinations. Three eyes (7%) required IOL exchange. CONCLUSIONS: Complaints of blurred vision and photic phenomena after multifocal IOL implantation were effectively managed with appropriate treatment. Few eyes (7%) required IOL exchange. Neodymium:YAG capsulotomy should be delayed until it has been determined that IOL exchange will not be necessary.

Herpetic Eye Disease Study: A Controlled Trial of Topical Corticosteroids for Herpes Simplex Stromal Keratitis

PURPOSE To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis. METHODS The authors performed a randomized, double-masked, placebo-controlled, multicenter clinical trial of 106 patients with active herpes simplex stromal keratitis who had not received any corticosteroids for at least 10 days before study enrollment. Patients were assigned to the placebo group (n = 49) or the steroid group (topical prednisolone phosphate; n = 57); both regimens were tapered over 10 weeks. Both groups received topical trifluridine. Visual acuity assessment and slit-lamp biomicroscopy were performed weekly for 10 weeks, every other week for an additional 6 weeks or until removal from the trial, and at 6 months after randomization. RESULTS The time to treatment failure (defined by specific criteria as persistent or progressive stromal keratouveitis or an adverse event) was significantly longer in the steroid group compared with the placebo group. Compared with placebo, corticosteroid therapy reduced the risk of persistent or progressive stromal keratouveitis by 68%. The time from randomization to resolution of stromal keratitis and uveitis was significantly shorter in the steroid group compared with the placebo group even though both groups included patients who were removed from the study and treated with topical corticosteroids according to best medical judgment. Nineteen (33%) of the steroid-treated patients and 11 (22%) of the placebo-treated patients completed the 10 weeks of protocol therapy and had stable, noninflamed corneas after 16 weeks. At 6 months after randomization, no clinically or statistically significant differences in visual outcome or recurrent herpetic eye disease were identified between the steroid and placebo groups. CONCLUSIONS The topical corticosteroid regimen used in this study was significantly better than placebo in reducing persistence or progression of stromal inflammation and in shortening the duration of herpes simplex stromal keratitis. Postponing steroids during careful observation for a few weeks delayed resolution of stromal keratitis but had no detrimental effect as assessed by visual outcome at 6 months.

Validation of the Ectasia Risk Score System for Preoperative Laser in Situ Keratomileusis Screening

PURPOSE To validate the Ectasia Risk Score System for identifying patients at high risk for developing ectasia after laser in situ keratomileusis (LASIK). DESIGN Retrospective case-control study. METHODS Fifty eyes that developed ectasia and 50 control eyes with normal postoperative courses after LASIK were analyzed and compared using the previously described Ectasia Risk Score System, which assigns points in a weighted fashion to the following variables: topographic pattern, predicted residual stromal bed (RSB) thickness, age, preoperative corneal thickness (CT), and manifest refraction spherical equivalent (MRSE). RESULTS In this series, 46 (92%) eyes with ectasia were correctly classified as being at high risk for the development of ectasia, while three (6%) controls were incorrectly classified as being at high risk for ectasia (P < 1 x 10(-10)). Significantly more eyes were classified as high risk by the ectasia risk score than by traditional screening parameters relying on abnormal topography or RSB thickness less than 250 micro (92% vs 50%; P < .00001). There was no difference in the sensitivity or specificity of the Ectasia Risk Score System in the population from which it was derived and this independent population of ectasia cases and controls. CONCLUSIONS The Ectasia Risk Score System is a valid and effective method for detecting eyes at risk for ectasia after LASIK and represents a significant improvement over previously utilized screening strategies.

Results of Phase III Excimer Laser Photorefractive Keratectomy for Myopia

OBJECTIVE The purpose of the study is to determine safety and efficacy outcomes of excimer laser photorefractive keratectomy (PRK) for the treatment of mild-to-moderate myopia. DESIGN A prospective, multicenter, phase III clinical trial. PARTICIPANTS A total of 701 eyes of 701 patients were entered in the study; 612 eyes were examined at 2 years after surgery. INTERVENTION Intervention was photorefractive keratectomy using the Summit ExciMed UV200LA excimer laser (Summit Technology, Inc., Waltham, MA). The treatment zone diameter used was 4.5 mm in 251 eyes (35.8%) and 5 mm in 450 eyes (64.2%). Attempted corrections ranged from 1.50 to 6.00 diopters (D). MAIN OUTCOME MEASURES Predictability and stability of refraction, uncorrected and spectacle-corrected visual acuity, refractive and keratometric astigmatism, corneal haze, contrast sensitivity, subjective reported problems of glare and halo, and patient satisfaction were the parameters measured. RESULTS At 2 years, 407 (66.5%) eyes achieved 20/20 or better uncorrected visual acuity and 564 (92.5%) eyes achieved 20/40 or better visual acuity. Three hundred thirty-six (54.9%) eyes were within 0.5 D and 476 (77.8%) eyes were within 1.0 D of attempted correction. Stability of refraction improved with time; 86.8% of eyes were stable within 1.0 D from 6 to 12 months, 94% were stable from 12 to 18 months, and 96.3% were stable from 18 to 24 months. There was no evidence of progressive or late myopic or hyperopic refractive shifts. One hundred fourteen (18.6%) eyes gained 2 or more lines of spectacle-corrected visual acuity, whereas 42 (6.9%) eyes lost 2 or more lines; however, of the latter, 32 (76.2%) had spectacle-corrected visual acuity of 20/25 or better and 39 (92.9%) eyes had 20/40 or better. Four hundred forty-two (72.2%) corneas were clear, 138 (22.5%) showed trace haze, 20 (3.3%) mild haze, 9 (1.5%) moderate haze, and 3 (0.5%) marked haze. On patient questionnaires, 87 (29.7%) patients reported worsening of glare from preoperative baseline; 133 (50.1%) reported worsening of halo symptoms from baseline. CONCLUSIONS Photorefractive keratectomy appears effective for myopic corrections of -1.50 to -6.00 D. Uncorrected visual acuity is maximized in most eyes by 3 months, although some patients require between 6 months and 1 year to attain their best postoperative uncorrected visual acuity and some may require from 1 to 2 years for stabilization of refraction. Refraction stabilizes progressively without evidence of late myopic or hyperopic refractive shifts. Optical sequelae of glare and halo occur in some patients treated with a 4.5- or 5-mm treatment zone.

Herpetic Eye Disease Study: A Controlled Trial of Oral Acyclovir for Herpes Simplex Stromal Keratitis

PURPOSE To evaluate the efficacy of oral acyclovir in treating stromal keratitis caused by herpes simplex virus (HSV) in patients receiving concomitant topical corticosteroids and trifluridine. METHODS The authors performed a randomized, double-masked, placebo-controlled, multicenter trial in 104 patients with HSV stromal keratitis without accompanying HSV epithelial keratitis. Sample size was chosen so that a 5%, one-tailed test would have an 80% chance of detecting a doubling of the median time to treatment failure. Patients were randomized to receive a 10-week course of either oral acyclovir (400 mg 5 times daily, n = 51) or placebo (n = 53). All patients also received a standard regimen of topical prednisolone phosphate and trifluridine. Ophthalmologic examinations were performed weekly during the 10-week treatment period, every 2 weeks for an additional 6 weeks, and at 6 months after entry into the trial. RESULTS The median time to treatment failure (defined as worsening or no improvement of stromal keratitis or an adverse event) was 84 days (95% confidence interval, 69-93 days) for the acyclovir group and 62 days (95% confidence interval, 57-90 days) for the placebo group. By 16 weeks, 38 patients (75%) in the acyclovir group and 39 patients (74%) in the placebo group had failed treatment. Also by that time, the keratitis had resolved with trial medications, and there was no subsequent worsening in nine patients (18%) in the acyclovir group and ten (19%) in the placebo group. None of these results were significantly different between the two groups. However, visual acuity improved over 6 months in significantly more patients in the acyclovir group than in the placebo group. CONCLUSION There was no statistically or clinically significant beneficial effect of oral acyclovir in treating HSV stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine with regard to time to treatment failure, proportion of patients who failed treatment, proportion of patients whose keratitis resolved, time to resolution, or 6-month best-corrected visual acuity. Visual acuity improved over 6 months in more patients in the acyclovir group than in the placebo group.