A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years.

SIGNIFICANCE: Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial. PURPOSE: This study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone. METHODS: Children (mean age, 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (prescribed 1 h/d, 5 d/wk [n = 92], or continued spectacle correction alone [n = 90]) in a multicenter randomized clinical trial. Before enrollment, children wearing spectacles were required to have at least 16 weeks of wear or no improvement in amblyopic-eye VA (<0.1 logMAR) for at least 8 weeks. Outcome was change in amblyopic-eye VA from baseline to 4 weeks (primary) and 8 weeks (secondary) assessed by masked examiner. RESULTS: A total of 182 children with anisometropic (63%), strabismic (16%; <5∆ near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200; mean, 20/63) were enrolled. After 4 weeks, mean amblyopic VA improved by 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference, 0.5 lines; 95.1% confidence interval [CI], 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement, 1.3 vs. 1.0 logMAR lines with spectacles alone; adjusted difference, 0.3 lines; 98.4% CI, -0.2 to 0.8 lines) were inconclusive because the CI included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines. CONCLUSIONS: In 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA for 4 weeks but not 8 weeks. Future work is required to determine if modifications to the contrast increment algorithm or other aspects of the game or its implementation could enhance the treatment effect.

A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age.

PURPOSE: To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation. DESIGN: Prospective randomized clinical trial (RCT). METHODS: One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as "failed" if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up. RESULTS: Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%-26%) of 41 assigned to glasses and four (9%; 95% CI: 3%-22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%-18%; P = .72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%-43%) assigned to glasses and 27% (95% CI: 17%-42%) assigned to observation. CONCLUSIONS: In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.

Comparison of EX-PRESS Shunt and Trabeculectomy With Mitomycin-C in Congenital and Juvenile Glaucoma.

PURPOSE: To compare efficacy and safety of EX-PRESS mini glaucoma shunt (Alcon) and trabeculectomy with mitomycin-C (MMC) in the management of pediatric glaucoma. METHODS: The authors retrospectively reviewed patients from a single pediatric ophthalmology practice with either congenital or juvenile glaucoma who underwent surgical treatment with either trabeculectomy or EX-PRESS shunt insertion with MMC. Postoperative intraocular pressure at 6, 18, and 36 months, medication requirements, visual acuities, postoperative interventions, complications, and noncompliance with medications or follow-up was reviewed. RESULTS: A total of 42 cases of glaucoma with either trabeculectomy or EX-PRESS shunt were identified for review (n trabeculectomy=25, n EX-PRESS=17). At 6 months, 62.5% of trabeculectomies and 94.1% of EX-PRESS shunts met criteria for success (P=0.0281). At 18 months, 38.1% of trabeculectomies and 81.3% of EX-PRESS shunts met criteria for success (P=0.0178). At 36 months, trabeculectomies had a success rate of 33.3% versus 66.7% for EX-PRESS shunts (P=0.321). The average decrease in medications postoperatively was 0.375 and 1.63 for trabeculectomy and EX-PRESS shunt, respectively (P=0.06). Preoperative visual acuities compared with postoperative best-corrected visual acuities before additional surgery demonstrated a slight average worsening of 0.11 logMAR in trabeculectomy patients and an average improvement of 0.56 logMAR in EX-PRESS shunt patients (P=0.0037). CONCLUSIONS: In this review, patients with pediatric glaucoma managed with EX-PRESS shunt with MMC compared with trabeculectomy with MMC appear to have better intraocular pressure control, better visual acuities, and fewer complications and reoperations.

Cyclosporin as an adjunct to glaucoma filtration surgery.

PURPOSE: Current adjunctive therapies to glaucoma surgery have unreliable effects, are toxic, and have numerous late complications associated with their use. This study examined whether topical cyclosporin (CsA) prolongs bleb survival after glaucoma filtration surgery. METHODS: Anesthetized white New Zealand rabbits underwent glaucoma filtration surgery with a drainage tube. Cyclosporin (2%), applied intraoperatively or as topical treatment following glaucoma filtration surgery, was compared with intraoperative mitomycin C (MMC) and an untreated control group. RESULTS: The bleb remained elevated for 15.1 +/- 3.2 days in the untreated control group, 12.2 +/- 2.1 days after intraoperative cyclosporin, and 27.5 +/- 1.7 days after intraoperative mitomycin C (P < 0.001). When topical treatment with cyclosporin followed intraoperative mitomycin C, bleb survival significantly decreased to 19.2 +/- 4.6 days (P = 0.003). Intraocular pressure (IOP) remained significantly reduced in the mitomycin C-treated group longer than in either the control or cyclosporine-treated groups. CONCLUSIONS: In comparison with mitomycin C, neither intraoperative nor postoperative treatment with cyclosporin was associated with a decrease in intraocular pressure or prolonged bleb survival. Contrary to the initial hypothesis, topical treatment with cyclosporin actually mitigated the beneficial effects of mitomycin C on bleb survival. Clinical implications of these findings for patients with functioning blebs deserve further study.

Randomized trial of treatment of amblyopia in children aged 7 to 17 years.

OBJECTIVE: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years. METHODS: At 49 clinical sites, 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group (2-6 hours per day of prescribed patching combined with near visual activities for all patients plus atropine sulfate for children aged 7 to 12 years) or an optical correction group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (> or =2 lines) by 24 weeks were considered responders. RESULTS: In the 7- to 12-year-olds (n = 404), 53% of the treatment group were responders compared with 25% of the optical correction group (P<.001). In the 13- to 17-year-olds (n = 103), the responder rates were 25% and 23%, respectively, overall (adjusted P = .22) but 47% and 20%, respectively, among patients not previously treated with patching and/or atropine for amblyopia (adjusted P = .03). Most patients, including responders, were left with a residual visual acuity deficit. CONCLUSIONS: Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years, although most patients who are initially treated with optical correction alone will require additional treatment for amblyopia. For patients aged 7 to 12 years, prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated. For patients 13 to 17 years, prescribing patching 2 to 6 hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated but appears to be of little benefit if amblyopia was previously treated with patching. We do not yet know whether visual acuity improvement will be sustained once treatment is discontinued; therefore, conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study we are conducting on the patients who responded to treatment.

Finite element model of cornea deformation.

Cornea surgeons have observed that changes in cornea curvature can follow cataract surgery and cause astigmatism. The placement of surgical incisions has been shown to influence these curvature changes. Though empirical data has been collected about this phenomenon, a biomechanical model has not been employed in predicting post-surgical outcomes. This work implemented an incised finite element model of the eye to investigate factors influencing corneal shape after surgery. In particular, the effects of eye muscle forces and intra-ocular pressure were simulated. Cornea shape change was computed via finite element analysis, and the resulting change in cornea curvature was measured by fitting quadratic curves to the horizontal and vertical meridians of the cornea. Results suggest that these two sources of deforming force counteract each other and contribute to astigmatism in perpendicular directions.

Cyclosporin-augmented laser peripheral iridoplasty.

BACKGROUND AND OBJECTIVE: Almost all patients develop iritis following argon laser peripheral iridoplasty. Numerous adverse effects, particularly elevated intraocular pressure (IOP) and reduced microbial resistance, complicate therapy with topical corticosteroids. An immunomodulator, such as cyclosporin A (CsA), avoids these undesirable effects, yet may suppress ocular inflammation. MATERIALS AND METHODS: Argon laser peripheral iridoplasty was performed on anesthetized rabbits with pigmented iris epithelium. Rabbits were randomly assigned to the untreated control, CsA (2%), or dexamethasone (0.1%) groups. Postoperative inflammation was documented by digital photography, IOP, and protein in aqueous humor. RESULTS: Iris injection, aqueous flare, and fibrin decreased most rapidly in the control group, as did protein in aqueous humor. Decreases in IOP of 49% to 58% were similar in all three groups. There were no differences in conjunctival congestion between the CONCLUSION: Neither treatment with antiinflammatory drugs that inhibit phagocytosis (e.g., topical steroids) nor treatment with anti-inflammatory drugs that suppress T-lymphocytes (e.g., topical sA) significantly attenuated inflammation following iridoplasty.

Intraocular lens implantation during infancy: perceptions of parents and the American Association for Pediatric Ophthalmology and Strabismus members.

BACKGROUND: To determine whether a randomized clinical trial, the Infant Aphakia Treatment Study, comparing intraocular lens (IOL) implantation with contact lens (CL) correction for infants with a unilateral congenital cataract (UCC), is feasible by (1) ascertaining whether American Association for Pediatric Ophthalmology and Strabismus (AAPOS) members have equipoise regarding these two treatments and (2) evaluating the willingness of parents to agree to randomization. METHODS: All AAPOS members were surveyed in August 1997 and again in June 2001 regarding their use of CLs and IOL implants to correct infants vision after unilateral cataract surgery. In addition, a pilot study was begun in March 2002 to evaluate the safety of IOL implantation during infancy and the willingness of parents to randomize their children with a UCC to either IOL implantation or CL correction. RESULTS: In 1997, 89% of the 260 respondents reported that in the previous year they had treated at least one infant with a UCC, but only 4% had implanted an IOL in an infant <7 months old. Silsoft (Bausch & Lomb, Rochester, NY) CL correction was the preferred treatment choice for 84% of the respondents. In 2001, 21% of the 279 respondents had implanted an IOL in an infant. On a scale from 1 to 10 with 1 strongly favoring an IOL implant and 10 strongly favoring a CL, the median score was 7.5. Sixty-one percent of the respondents indicated that they would be willing to randomize children with a UCC to one of these two treatments. The main concerns about IOL implantation were poor predictability of power changes, postoperative complications, inflammation, and technical difficulty of surgery. The main concerns about CL correction were poor compliance, high lens loss rate, high cost, and keratitis. In our pilot study, 30 infants <7 months of age were evaluated at nine clinical centers for a visually significant UCC. Of 24 infants eligible for randomization, the parents of 17 (71%) agreed to randomization. CONCLUSIONS: Although most AAPOS members still favor CL correction after cataract surgery for a UCC, five times as many had implanted an IOL in an infant in 2001 compared with the number in 1997. Parents were almost equally divided in their preference for IOL implant versus CL correction. Given the relative equipoise of AAPOS members regarding these treatments and the willingness of more than two thirds of parents to agree to randomization, it seems likely that a randomized clinical trial comparing these two treatments could indeed be conducted.

Prospective analysis of pediatric pseudophakia: myopic shift and postoperative outcomes.

PURPOSE: Limited data exist about long-term refractive changes in eyes of children with intraocular lens (IOL) implantation. Information of postoperative results should allow more accurate predictions for IOL power implantation in children. Data regarding IOL complications, including secondary membranes, myopic shift, stereopsis, and pseudophakic glaucoma should also be reported. METHODS: In a prospective study, the refractive errors of all pediatric patients between 12 months and 18 years who had cataract surgery and IOL implantation were evaluated at 4 weeks, 3 months, 6 months, 1 year, and every 6 months thereafter. All patients were followed for a minimum of 3 years. RESULTS: Fifty-two eyes of 42 patients met inclusion criteria. Forty-two eyes had developmental cataracts. There were 10 bilateral cases. Of the 52 eyes, 85% had 20/40 vision or better. Visual acuity of 20/30 or better was achieved in 95% of bilateral eyes. In unilateral cataracts, visual acuity was 20/50 or better in 74% of eyes. Mean follow-up time was 5.45 years with a range of 3 to 10.5 years. Mean follow-up by age group ranged between 4.38 and 6.35 years. Children operated on at 12 months to 2 years of age had a mean myopic shift of -5.96 D; children operated on at 3 and 4 years of age had a -3.66 D shift; children operated on at 5 and 6 years of age had a shift of -3.40 D; children operated on at 7 and 8 years of age had a shift of -2.03 D; children operated on at 9 and 10 years of age had a mean shift of -1.88 D; children operated on at 11 to 14 years of age had a shift of -0.97 D; children operated on at 15 to 18 years of age had -0.38 D shift. No cases of pediatric pseudophakic glaucoma were observed. Secondary membrane occurred in 72% of eyes when the capsule was left intact. The operated eye showed a greater mean myopic shift than the nonoperated eye. No statistically significant difference in refractive change was found comparing amblyopic to nonamblyopic eyes or traumatic to nontraumatic cataracts. CONCLUSIONS: The greatest rate of refractive growth or change occurred between 1 and 3 years of age. After age 3 years, the rate of refractive growth followed a more linear trend. Based on this study, we have provided a guide for selecting IOL power in pediatric cataract cases using current formulas with the understanding that new formulas will need to be devised to better predict IOL power in children.