Long-term Follow-up of a Phase 1/2a Clinical Trial of a Stem Cell-Derived Bioengineered Retinal Pigment Epithelium Implant for Geographic Atrophy.

PURPOSE: To report long-term results from a phase 1/2a clinical trial assessment of a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant in patients with advanced geographic atrophy (GA). DESIGN: A single-arm, open-label phase 1/2a clinical trial approved by the United States Food and Drug Administration. PARTICIPANTS: Patients were 69-85 years of age at the time of enrollment and were legally blind in the treated eye (best-corrected visual acuity [BCVA], ≤ 20/200) as a result of GA involving the fovea. METHODS: The clinical trial enrolled 16 patients, 15 of whom underwent implantation successfully. The implant was administered to the worse-seeing eye with the use of a custom subretinal insertion device. The companion nonimplanted eye served as the control. The primary endpoint was at 1 year; thereafter, patients were followed up at least yearly. MAIN OUTCOME MEASURES: Safety was the primary endpoint of the study. The occurrence and frequency of adverse events (AEs) were determined by scheduled eye examinations, including measurement of BCVA and intraocular pressure and multimodal imaging. Serum antibody titers were collected to monitor systemic humoral immune responses to the implanted cells. RESULTS: At a median follow-up of 3 years, fundus photography revealed no migration of the implant. No unanticipated, severe, implant-related AEs occurred, and the most common anticipated severe AE (severe retinal hemorrhage) was eliminated in the second cohort (9 patients) through improved intraoperative hemostasis. Nonsevere, transient retinal hemorrhages were noted either during or after surgery in all patients as anticipated for a subretinal surgical procedure. Throughout the median 3-year follow-up, results show that implanted eyes were more likely to improve by > 5 letters of BCVA and were less likely to worsen by > 5 letters compared with nonimplanted eyes. CONCLUSIONS: This report details the long-term follow-up of patients with GA to receive a scaffold-based stem cell-derived bioengineered RPE implant. Results show that the implant, at a median 3-year follow-up, is safe and well tolerated in patients with advanced dry age-related macular degeneration. The safety profile, along with the early indication of efficacy, warrants further clinical evaluation of this novel approach for the treatment of GA. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Survival of an HLA-mismatched, bioengineered RPE implant in dry age-related macular degeneration.

Cell-based therapies face challenges, including poor cell survival, immune rejection, and integration into pathologic tissue. We conducted an open-label phase 1/2a clinical trial to assess the safety and preliminary efficacy of a subretinal implant consisting of a polarized monolayer of allogeneic human embryonic stem cell-derived retinal pigmented epithelium (RPE) cells in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration. Postmortem histology from one subject with very advanced disease shows the presence of donor RPE cells 2 years after implantation by immunoreactivity for RPE65 and donor-specific human leukocyte antigen (HLA) class I molecules. Markers of RPE cell polarity and phagocytosis suggest donor RPE function. Further histologic examination demonstrated CD34+ structures beneath the implant and CD4+, CD68+, and FoxP3+ cells in the tissue. Despite significant donor-host HLA mismatch, no clinical signs of retinitis, vitreitis, vasculitis, choroiditis, or serologic immune response were detected in the deceased subject or any other subject in the study. Subretinally implanted, HLA-mismatched donor RPE cells survive, express functional markers, and do not elicit clinically detectable intraocular inflammation or serologic immune responses even without long-term immunosuppression.

One-Year Follow-Up in a Phase 1/2a Clinical Trial of an Allogeneic RPE Cell Bioengineered Implant for Advanced Dry Age-Related Macular Degeneration.

Purpose: To report 1-year follow-up of a phase 1/2a clinical trial testing a composite subretinal implant having polarized human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells on an ultrathin parylene substrate in subjects with advanced non-neovascular age-related macular degeneration (NNAMD). Methods: The phase 1/2a clinical trial included 16 subjects in two cohorts. The main endpoint was safety assessed at 365 days using ophthalmic and systemic exams. Pseudophakic subjects with geographic atrophy (GA) and severe vision loss were eligible. Low-dose tacrolimus immunosuppression was utilized for 68 days in the peri-implantation period. The implant was delivered to the worst seeing eye with a custom subretinal insertion device in an outpatient setting. A data safety monitoring committee reviewed all results. Results: The treated eyes of all subjects were legally blind with a baseline best-corrected visual acuity (BCVA) of ≤ 20/200. There were no unexpected serious adverse events. Four subjects in cohort 1 had serious ocular adverse events, including retinal hemorrhage, edema, focal retinal detachment, or RPE detachment, which was mitigated in cohort 2 using improved hemostasis during surgery. Although this study was not powered to assess efficacy, treated eyes from four subjects showed an increased BCVA of >5 letters (6-13 letters). A larger proportion of treated eyes experienced a >5-letter gain when compared with the untreated eye (27% vs. 7%; P = not significant) and a larger proportion of nonimplanted eyes demonstrated a >5-letter loss (47% vs. 33%; P = not significant). Conclusions: Outpatient delivery of the implant can be performed routinely. At 1 year, the implant is safe and well tolerated in subjects with advanced dry AMD. Translational Relevance: This work describes the first clinical trial, to our knowledge, of a novel implant for advanced dry AMD.

Phase 2 study of hyper-CMAD with liposomal vincristine for patients with newly diagnosed acute lymphoblastic leukemia.

Liposomal vincristine is designed to reduce neurotoxicity and increase dose intensity delivery, and has been approved as salvage therapy in relapsed/refractory acute lymphoblastic leukemia (ALL). Our aim was to evaluate the response rate, toxicities, and outcome of adults with newly diagnosed ALL who received liposomal vincristine, rather than regular vincristine in combination with intensive chemotherapy (Hyper-CMAD). In a single-center, phase 2 study, patients ≥18 years with newly-diagnosed B-cell ALL were eligible to receive hyper-CMAD alternating with high-dose methotrexate and cytarabine. Rituximab was administered in CD20 positive ALL. Tyrosine kinase inhibitors (imatinib or dasatinib) were added in Philadelphia chromosome-positive (Ph-positive) ALL. Thirty-one patients were enrolled, median follow-up of 59 months (0.3-70). Thirteen patients (42%) had CD20 positive ALL, and 21 (68%) had Ph-positive ALL. Thirty (97%) achieved complete remission (CR). All 26 patients with abnormal karyotype achieved complete cytogenetic response (CCyR), and 27/30 (90%) achieved negative minimal residual disease status by multicolor flow cytometry. Of 20 evaluable Ph-positive ALL patients, major molecular response (MMR) was achieved in 19 patients (95%); complete molecular response (CMR) in 14 (70%). Grade 3/4 peripheral neuropathy was observed in five (16%) with all grade peripheral neuropathy in 21 (68%). With a median follow-up of 59 months, 21 (68%) patients are alive. The 5-year CR duration and survival rates were 73% and 61%, respectively. Ten (32%) patients died: one, sepsis on C1D10; four, unknown; one, post-transplant complications; four, relapse. Hyper-CMAD with liposomal vincristine is safe and demonstrated high response and survival rates in newly diagnosed ALL.

Metallic intraocular foreign body as detected by magnetic resonance imaging without complications- A case report.

PURPOSE: To describe a case and present unique images of a metallic intraocular foreign body that was identified in a 12-year-old male patient who underwent routine magnetic resonance imaging (MRI) to assess neurodevelopmental delay. OBSERVATIONS: We present MRI and diagnostic imaging of a metallic intraocular foreign body in a young patient with no known history of trauma or reason for the existence of metal in the eye area. Computed tomography scan was performed to confirm the presence of the intraocular foreign body, followed by optical coherence tomography and electroretinogram to assess visual status. It was determined that no surgical intervention was currently required as no visual impairment or ocular toxicity was identified. The patient continues to be monitored. CONCLUSIONS AND IMPORTANCE: This case presentation highlights the novel imaging features of a metallic intraocular foreign body, unexpectedly detected with MRI.

Low-dose ranibizumab as primary treatment of posterior type I retinopathy of prematurity.

OBJECTIVE: The aim of this study was to evaluate the visual and structural outcomes of eyes that received ranibizumab as treatment for retinopathy of prematurity (ROP). METHODS: This was a retrospective case series of infants who received a 0.2 mg (0.02 mL) intravitreal injection of ranibizumab as the primary treatment for type 1 ROP. Outcome measures included regression or recurrence of ROP, complications of treatment, and assessment of visual acuity and refractive error. RESULTS: Forty-two eyes of 21 infants (13 male) were included. Mean gestational age and birth weight were 24.6 ± 1.3 weeks and 613 ± 91 g, respectively. Mean age at injection was 37.4 ± 2.2 weeks postmenstrual age, and mean follow-up period was 10.1 ± 7 months. Active neovascularization regressed rapidly, and anatomical outcomes were favourable in all eyes. Twelve eyes of 6 infants received supplemental laser photocoagulation at a mean post-menstrual age (PMA) of 72.0 ± 27.3 weeks when vascularization had not advanced beyond zone II. Visual acuity was measurable in 28 of 42 eyes. Mean visual acuity was 0.94 ± 0.36 logMAR. Mean spherical equivalent was +1.00. There were no ocular or systemic complications in these patients and no cicatricial complications were observed with no progression to stage 4 or 5 disease. CONCLUSIONS: A single intravitreal dose of 0.2 mg (0.02 mL) ranibizumab showed favourable anatomical and functional outcomes in eyes with type 1 ROP.

Evaluation of outer retinal tubulations in eyes switched from intravitreal ranibizumab to aflibercept for treatment of exudative age-related macular degeneration.

PURPOSE: To evaluate the changes of outer retinal tubulations (ORTs) as seen on spectral-domain optical coherence tomography (SD OCT) in eyes with neovascular age-related macular degeneration (AMD) where treatment was switched from intravitreal ranibizumab to intravitreal aflibercept. METHODS: This was a prospective study of eyes diagnosed with neovascular AMD and previously treated with >6 intravitreal ranibizumab injections and switched to aflibercept, conducted at a single centre (Department of Ophthalmology at Pitié Salpetriere Hospital, Paris VI University) from January to July 2015. Before and after treatment was switched from ranibizumab to aflibercept, SD-OCT was used to evaluate the presence of ORTs. Additional assessments in this patient group included best-corrected visual acuity (BCVA), fluorescein angiography (FA), indocyanine green angiography (ICGA). Changes in pigment epithelium detachments (PED), presence of intraretinal cysts, and presence of subretinal fluid (SRF) were also noted. RESULTS: Twenty-four eyes of 24 consecutive patients (15 female/nine male, mean age 70 years) diagnosed with neovascular AMD and previously treated with >6 intravitreal ranibizumab injections and switched to aflibercept were included in the analysis. After receiving aflibercept, patients were followed for a mean of 6.1 months. Prior to treatment switch, 97 % of eyes showed ORTs, while after treatment switch to aflibercept, at the end of the study period, 75 % had ORTs (p = 0.219). Changes in BCVA (LogMAR) were not statistically significant (1.16 ± 0.44 to 1.18 ± 1.06, p = 0.12), however, a significant reduction in central macular thickness (CMT) (from 406 µm ± 112 to 263 µm ± 68, p = 0.001), PED (from 70.8 % to 41.7 % , p = 0.016), presence of intraretinal cysts (from 83.3 % to 33.3 %, p = 0.002) and SRF (from 91.7 % to 25 %, p = 0.001 ) were noted. CONCLUSION: After switching from ranibizumab treatment to aflibercept, ORTs remained present in 75 % of eyes, and significant reductions in CMT, PED, and SRF, and presence of intraretinal cysts were observed.

Ocular Applications of Dipyridamole: A Review of Indications and Routes of Administration.

Dipyridamole was introduced decades ago as a treatment for angina, subsequently found to inhibit platelet aggregation. It is most commonly used, and approved for use in thromboembolism prevention, following surgery. Some of its recognized effects such as adenosine uptake inhibition, elevation of cAMP and cGMP levels, vasodilation, and tissue perfusion are important in various ocular disorders. For this reason, dipyridamole represents an interesting candidate as a therapeutic target for the treatment of eye disorders affecting different ocular structures. The aim of this article is to review the evidence and current understanding of the mechanisms by which dipyridamole exerts its effects on different ocular tissues, discuss the role of dipyridamole in clinical practice, and highlight areas of use and routes of administration.

Laser-assisted subepithelial keratectomy and photorefractive keratectomy for post-penetrating keratoplasty myopia and astigmatism in adults.

PURPOSE: To evaluate whether laser-assisted subepithelial keratectomy (LASEK) and photorefractive keratectomy (PRK) achieve effective targeted correction and the extent of post-treatment corneal haze after corneal transplantation. SETTING: Nonhospital surgical facility, Calgary, Alberta, Canada. DESIGN: Evidence-based manuscript. METHODS: This study evaluated visual acuity, refractive error correction, and potential complications after LASEK or PRK to eliminate refractive error differences after penetrating keratoplasty in adults. A Nidek EC-5000 or Technolas 217 excimer laser was used in all treatments. RESULTS: At last follow-up (mean 20.50 months post laser), the mean spherical equivalent (SE) decreased from -2.71 diopters (D) ± 4.17 (SD) to -0.54 ± 3.28 D in the LASEK group and from -4.87 ± 3.90 D to -1.82 ± 3.34 D in the PRK group. The mean preoperative uncorrected distance visual acuity (UDVA) was 1.63 ± 0.53 and 1.45 ± 0.64, respectively, and the mean postoperative UDVA, 0.83 ± 0.54 and 0.90 ± 0.55, respectively. The improvement in SE and UDVA was statistically significant in both groups (P < .01). The mean haze (0 to 3 scale) at the last follow-up was 0.46 ± 0.708 in the LASEK group and 0.58 ± 0.776 in the PRK group. CONCLUSIONS: The UDVA improved and refractive errors were effectively reduced after LASEK or PRK in eyes with previous PKP. There was no significant difference in the change in SE, UDVA, or corrected distance visual acuity between LASEK and PRK. Some patients had evidence of corneal haze, although the difference between the groups was not significant.

Severe retinopathy of prematurity associated with FZD4 mutations.

PURPOSE: To determine whether mutations in the FZD4 gene are a risk factor for developing severe ROP. METHODS: Three Canadian tertiary care centers recruited premature infants prospectively and retrospectively, and assigned affectation status based on the maximum degree of severity of ROP recorded in both eyes. Mutation screening of the FZD4 gene was performed using direct sequencing. All sequence changes were evaluated for functional significance. RESULTS: Two novel FZD4 mutations (Ala370Gly or Lys203Asn) were identified in two infants from the severe ROP group (n=71). No mutation was detected in the mild to no ROP group (n=33), and the two novel mutations were absent in 173 random Caucasian samples. Mutation Ala370Gly was also found in one sibling and one parent of the affected infant, but no signs of familial exudative vitreoretinopathy (FEVR), a condition with phenotypic overlap with ROP known to be caused by FZD4 mutations, were present in either family member. CONCLUSIONS: Mutations in the FZD4 gene in this group of premature infants supports a role for the FZD4 pathway in the development of severe ROP and accounts for approximately 3% of severe ROP in Caucasian premature infants.

Surgical outcomes of primary foldable intraocular lens implantation in children: understanding posterior opacification and the absence of glaucoma.

PURPOSE: To evaluate visual and stereoscopic performance after pediatric cataract extraction with intraocular lens (IOL) implantation performed by the same surgeon over 24 years and to review the complications. SETTING: The Alberta Children's Hospital, Calgary, Alberta, Canada. METHODS: This retrospective review comprised children aged 1 month to 18 years who had small-incision cataract extraction with foldable posterior chamber IOL implantation from 1995 to 2008. RESULTS: The postoperative follow-up was 6 months to 12 years. Posterior capsule opacification (PCO) requiring secondary surgical membranectomy developed in 22.7% of the children. Younger children developed PCO more often than older children. The PCO rate was 70.8% in children younger than 1 year and decreased steadily to 6.1% in children older than 7 years. The mean onset of PCO was 6.1 months postoperatively. Other complications were vitreous tags (12.0%), IOL dislocation (4.7%), and loose corneal sclera sutures (2.7%). Of the eyes in which vision could be recorded, 89.5% had improved corrected visual acuity, with no eye losing acuity. Stereopsis was present in 35% of testable children preoperatively and 91% postoperatively. CONCLUSIONS: Cataract surgery in children younger than 2 years should be considered a 2-stage procedure in view of the higher incidence of PCO. Secondary glaucoma decreased significantly when surgery was performed after 30 days of age and the eye was left pseudophakic after surgery. Further improvements in IOL design, surgical instrumentation, and implantation techniques will continue to improve the ability to visually rehabilitate children.

Long-term outcomes of photorefractive keratectomy and laser-assisted subepithelial keratectomy in children.

PURPOSE: To assess the long-term refractive, visual acuity, binocular vision, and quality-of-life outcomes of photorefractive keratectomy (PRK) and laser-assisted subepithelial keratectomy (LASEK) in children. SETTING: Non-hospital surgical facility with follow-up in a hospital clinical setting. METHODS: In this retrospective review, 56 eyes of 39 patients had PRK or LASEK under general anesthesia. Patients were examined preoperatively and postoperatively at 2 and 6 months and 1 year and then annually for a minimum of 3.5 years. Recorded variables included demographics, refractive error, best corrected visual acuity (BCVA), stereopsis, corneal haze, and quality of life. RESULTS: The mean age at surgery was 6.5 years (range 1.0 to 17.4 years). At the final postoperative examination (mean 5.15 years), the mean spherical equivalent was -1.73 diopters (D) in all patients, -3.20 D in PRK patients, and -1.37 D in LASEK patients. Refraction and corneal clarity were stable over the long term in all eyes. In 28 eyes that were measurable preoperatively, visual acuity improved by a mean of 1.6 lines (range 0 to 7 lines). Seven patients (18%) had measurable stereopsis before surgery and 19 (49%), after PRK or LASEK. No patient had reduced BCVA or loss of binocular fusion postoperatively. On a quality-of-life questionnaire, no family recorded negative opinions of the procedure or negative social or functional outcomes postoperatively. CONCLUSION: Photorefractive keratectomy and LASEK were effective and stable surgical alternative treatments in children with refractive errors who were unable to tolerate or who failed conventional methods of treatment.

Laser-assisted subepithelial keratectomy for anisometropic amblyopia in children: outcomes at 1 year.

PURPOSE: To assess the refractive, visual acuity, and binocular results of laser-assisted subepithelial keratectomy (LASEK) for anisomyopia, anisohyperopia, and anisoastigmatia in children with various levels of amblyopia secondary to the anisometropic causes. SETTING: Nonhospital surgical facility with follow-up in a hospital clinic setting. METHODS: This retrospective review was of 53 children with anisometropia who had LASEK to correct the refractive difference between eyes. All LASEK procedures were performed using general anesthesia. Patients were divided into 3 groups according to their anisometropia as follows: myopic difference greater than 3.00 diopters (D), astigmatic difference greater than 1.50 D, and hyperopic difference greater than 3.50 D. The children were followed for at least 1 year, and their refractive status, visual acuity, and binocular vision were assessed and recorded at 2 and 6 months as well as 1 year. RESULTS: The mean age at treatment was 8.4 years (range 10 months to 16 years). The mean preoperative anisometropic difference was 6.98 D in the entire group, 9.48 D in the anisomyopic group, 3.13 D in the anisoastigmatic group, and 5.50 D in the anisohyperopic group. One year after LASEK, the mean anisometropic difference decreased to 1.81 D, 2.43 D, 0.74 D, and 2.33 D, respectively, and 54% of all eyes were within +/-1.00 D of the fellow eye, 68% were within +/-2.00 D, and 80% were within +/-3.00 D. Preoperative visual acuity and binocular vision could be measured in 33 children. Postoperatively, 63.6% of children had an improvement in best corrected visual acuity (BCVA) and the remainder had no noted change. No patient had a reduction in BCVA or a loss in fusional ability after LASEK. Of the 33 children, 39.4% had positive stereopsis preoperatively and 87.9% had positive stereopsis 1 year after LASEK. CONCLUSION: Laser-assisted subepithelial keratectomy is an effective surgical alternative to improve visual acuity in anisometropic children unable to tolerate conventional methods of treatment or in whom these methods fail.

Paediatric pseudophakia: analysis of intraocular lens power and myopic shift.

BACKGROUND: At the Alberta Children's Hospital, the authors have been performing paediatric cataract extraction with intraocular lens (IOL) implant for over 10 years. The authors examined the amount of myopic shift that occurs in various age groups and cataract types, in order to evaluate the success of predicting the appropriate power of IOL to implant. METHODS: This study is a retrospective review children undergoing small incision posterior chamber foldable IOL implantation between age 1 month and 18 years, from 1995 to 2005. 163 eyes of 126 patients underwent surgery. All patients were followed for a minimum of 6 months postoperatively. The children were divided into four groups at time of surgery: Group A: 1-24 months, Group B: 25-48 months, Group C: 49-84 months, Group D: 85 months-18 years. RESULTS: The mean target refraction for the groups were: Group A: +6.37 D, Group B: +4.66 D, Group C: +1.95 D, and Group D: +0.97 D. Children under 4 years experienced the most myopic shift and the largest mean rate of refractive change per year. Mean change Group A: -5.43 D, Group B: -4.16 D, Group C: -1.58 D, Group D: -0.71 D. Eighty-nine per cent of patients with unilateral cataracts had a postoperative refraction within 3.00 D of the fellow eye at last follow-up visit (mean=3.16 years). CONCLUSIONS: The rate of myopic shift is high in children under age 4 years at time of surgery, shifting as much as -12.00 D. The mean postoperative target refraction should probably be increased from previous literature recommendations. The patient's age at time of cataract surgery and the refractive power of fellow eye are all factors to consider when deciding what power IOL to surgically implant in a paediatric patient.

Trachoma control in Southern Zambia--an international team project employing the SAFE strategy.

PURPOSE: To determine the prevalence of trachoma and to measure the impact of the SAFE strategy (World Health Organization GET 2020 strategy) for treating trachoma in the Gwembe District of Southern Zambia. DESIGN: This is an observational study of the introduction of the SAFE strategy employing a collaborative approach and its impact on trachoma in the area. PARTICIPANTS: Three thousand eight hundred ninety two persons in communities at 26 well sites in the Gwembe district of Southern Zambia were included in this study. METHODS: New, clean water wells were drilled under local supervision for each of 26 identified villages. All people living in villages near the wells were screened for trachoma and then treated with antibiotic if required. Education on personal and environmental hygiene was provided by trained volunteers. Patients affected by trichiasis and corneal scarring received surgery, locally if possible. Attempts to control fly populations by cleaning villages, penning livestock, and digging latrines were undertaken. This was performed under advisement and consultation with local villagers and government officials. Data was collected on variables normally associated with trachoma and others relating to demographics, water quality, environment and hygiene. MAIN OUTCOME MEASURES: Prevalence of trachoma in the area at two years post introduction of SAFE strategy. RESULTS: The overall prevalence of trachoma in the area was 47% in 2001; however, the prevalence was 55% among children under 10 years. At two years post intervention, the overall prevalence of trachoma reduced to 7.6%, and decreased to 10.6% in children under 10 years, and 5.9% among adults. CONCLUSIONS: Continued monitoring and risk factors will need to continue to be addressed in order to sustain this trachoma control project in this area of Zambia.

Refractive laser surgery in children with coexisting medical and ocular pathology.

PURPOSE: To report the visual, refractive, and functional outcomes of photorefractive keratectomy (PRK) and of laser-assisted subepithelial keratectomy in a group of children with significant refractive error and underlying medical conditions or ocular pathology who were noncompliant with traditional management. SETTING: Nonhospital surgical facility and a hospital clinic. METHODS: This case series comprised 5 individual cases of anisometropic amblyopia and/or high myopia. Underlying medical and ocular conditions were as follows: upper eyelid hemangioma with oblique myopic astigmatism, Pelizaeus-Merzbacher leukodystrophy with nystagmus, Klippel-Trenaunay-Weber syndrome with glaucoma, incontinentia pigmenti with unilateral optic nerve atrophy, and Goldenhar syndrome with unilateral optic nerve hypoplasia. Photorefractive keratectomy or LASEK was performed in 6 eyes of 5 patients. Age range at the time of surgery was 1.0 to 7.0 years. All procedures were performed under general anesthesia. RESULTS: Best corrected visual acuity improved by 2 lines in 2 patients and 1 line in 2 patients by 6 months after surgery. Stereopsis and/or fusional status improved in 3 patients. Amblyopia treatment compliance improved in 1 patient. Alignment improved without strabismus surgery in 2 cases. A functional vision survey demonstrated a positive effect on the ability of all 5 children to function in their environment. CONCLUSION: During the period of visual cortical plasticity, refractive surgery, by eliminating the refractive component of amblyopia and by promoting fusional ability, provides considerable improvement in children, even those with underlying medical conditions associated with ocular pathology.

Laser-assisted subepithelial keratectomy in children.

PURPOSE: To evaluate whether laser-assisted subepithelial keratectomy (LASEK) achieves effective targeted myopic correction with less post-treatment corneal haze than observed with photorefractive keratectomy (PRK) in children who fail traditional forms of treatment for myopic anisometropic amblyopia and high myopia. SETTING: Nonhospital surgical facility with follow-up in a hospital clinic setting. METHODS: This prospective study comprised 36 eyes of 25 patients. The mean patient age at treatment was 8.27 years (range 1.0 to 17.4 years). Patients were divided into 3 groups: those with myopic anisometropic amblyopia (13 patients/13 eyes), those with bilateral high myopia (11 patients/22 eyes), and those with high myopia post-penetrating keratoplasty (1 patient/1 eye). All patients were treated with LASEK under general anesthesia using the Visx 20/20 B excimer laser and a multizone, multipass ablation technique. Although the myopia was as high as -22.00 diopters (D) spherical equivalent (SE) in some eyes, no eye was treated for more than -19.00 D SE. RESULTS: At 1 year, the mean SE decreased from -8.03 D to -1.19 D. Forty-four percent of eyes were within +/-1.0 D of the targeted correction; 78% of eyes had clear corneas with no haze. In the entire group, the mean best corrected visual acuity improved from 20/80 to 20/50. A functional-vision survey demonstrated a positive effect on the patients' ability to function in their environments after LASEK. CONCLUSIONS: Laser-assisted subepithelial keratectomy in children represents another method of providing long-term resolution of bilateral high myopia and myopic anisometropic amblyopia with minimal post-laser haze. The reduction in post-laser haze with LASEK compared to that with the standard PRK technique may represent an advantage in treating these complex patients.