TRANSPLANTATION OF SUBRETINAL STEM CELL-DERIVED RETINAL PIGMENT EPITHELIUM FOR STARGARDT DISEASE: A Phase I Clinical Trial.

PURPOSE: To assess the safety of injecting human embryonic stem cell retinal pigment epithelial cell dose to treat Stargardt disease. METHODS: In this prospective, Phase I clinical trial, human embryonic stem cell retinal pigment epithelial cells in suspension were injected into the subretinal space in eyes with the worse best-corrected visual acuity (BCVA). After vitrectomy/posterior hyaloid removal, a partial retinal detachment was created and the human embryonic stem cell retinal pigment epithelial cells were administered. Phacoemulsification with intraocular lens implantation was performed in eyes with lens opacity. All procedures were optical coherence tomography-guided. The 12-month follow-up included retinal imaging, optical coherence tomography, visual field/electrophysiologic testing, and systemic evaluation. The main outcome was the absence of ocular/systemic inflammation or rejection, tumor formation, or toxicity during follow-up. RESULTS: The mean baseline BCVAs in the phacoemulsification and no phacoemulsification groups were similar (1.950 ± 0.446 and 1.575 ± 0.303, respectively). One year postoperatively, treated eyes showed a nonsignificant increase in BCVA. No adverse effects occurred during follow-up. Intraoperative optical coherence tomography was important for guiding all procedures. CONCLUSION: This surgical procedure was feasible and safe without cellular migration, rejection, inflammation, or development of ocular or systemic tumors during follow-up.

Higher-order aberrations of age-related cataract.

PURPOSE: To analyze higher-order aberrations induced by different types of lenticular opacities. SETTING: Federal University of São Paulo, São Paulo, Brazil. METHODS: One hundred thirty-eyes of 65 patients with bilateral cataract, classified according to the Lens Opacities Classification System III (LOCS III), had complete ophthalmic examinations, corneal topography (EyeSys Technologies), and wavefront analysis (LADARWave, Alcon Laboratories). Patients with cataracts that could not be measured by a Hartmann-Shack sensor or those with coexisting ocular disease were excluded. Higher-order aberrations were compared between the nuclear, cortical, and posterior subcapsular groups for statistical significance. RESULTS: One hundred five eyes of 65 patients were assessed. Twenty-eight eyes (23.33%) had predominantly nuclear opacification (NO1-NO6 and C1-2), and 13 (10.83%) had mainly cortical opacification (C1-4). Sixty-four eyes (65.83%) had a mixed pattern of LOCS III classification, which hindered the establishment of a correlation between the aberrometry and cataract type. Eighteen eyes that presented with dense posterior subcapsular cataract (P4-5) and 7 eyes with cortical C5 LOCS III classification were excluded. In eyes with nuclear opacification, the mean spherical aberration with a 6.0 mm pupil was 0.45 microm +/- 0.17 (SD) and the mean coma was 0.29 +/- 0.13 microm. In eyes with predominantly cortical cataract, the mean spherical aberration was 0.12 +/- 0.10 microm and the mean coma was 0.49 +/- 0.23 microm. The cortical cataract group had statistically significantly higher coma than the other groups (P<.001). The nuclear cataract group had statistically significantly higher spherical aberrations than the other groups (P<.001). CONCLUSIONS: Different types of early lenticular opacities induced different wavefront aberration profiles. Coma predominated in the cortical cataract group, and spherical aberration predominated in the nuclear cataract group.

Wavefront analysis and contrast sensitivity of aspheric and spherical intraocular lenses: a randomized prospective study.

PURPOSE: To compare visual performance, total and high order wavefront aberrations (coma, spherical aberration, and other terms), and contrast sensitivity in 120 eyes implanted with one monofocal aspheric intraocular lens (IOL) and two spherical IOLs. DESIGN: Randomized prospective study. METHODS: Sixty patients were randomized to receive three IOL types: Alcon AcrySofIQ (40 eyes), AcrySofNatural (40 eyes), and advanced medical optic (AMO)Sensar (40 eyes). Complete ophthalmologic examination including uncorrected visual acuity (UCVA), best-spectacle corrected visual acuity (BSCVA), corneal topography, and wavefront analysis were performed preoperatively, 30 days, and 90 days postoperatively. Pelli-Robson chart test and functional acuity contrast testing (FACT-Optec6500) were performed approximately 50 days after surgery. Statistical analyses were performed using analysis chi(2), analysis of variance (ANOVA), and multiple comparisons Tukey test. RESULTS: After 90 days, all eyes had postoperative BSCVA > or =20/32. The AcrySofIQ IOL showed statistically significant less induction of spherical aberration (P < .001) when compared with the AMOSensar and the AcrySofNatural IOLs. The AMOSensar presented significantly less spherical aberration then the AcrySofNatural (P < .05). The AcrySofIQ also had lower values of total and high-order aberration (HOA) (P < .05) when compared with the AMOSensar and the AcrySofNatural. The mean values of trefoil 9, coma, and HOA root mean square (RMS) decreased between one and three months (P < .001, P < .001, P = .023, P < .001, respectively) in all groups. Mean Pelli-Robson contrast sensitivity values in photopic condition were similar between the groups. The AcrySofIQ showed better results in 3cpd spatial frequency in mesopic condition using FACT-Optec 6500 (P = .008), although there were no statistical differences in photopic and mesopic with glare conditions.