RESUMO
PURPOSE: The ROCC study (randomized study comparing ranibizumab to sham in patients with macular edema secondary to central Retinal vein OCClusion [CRVO]) evaluated the short-term effect of intravitreal ranibizumab injections on best-corrected visual acuity (BCVA) and macular edema. DESIGN: Prospective, multicenter, randomized, double-masked, placebo-controlled trial. METHODS: In this 6-month trial, 32 patients with macular edema secondary to CRVO were randomized to receive monthly intravitreal ranibizumab (0.5 mg/0.05 mL) or sham injections for 3 consecutive months. If macular edema persisted, patients received further monthly injections. Primary outcome measures were BCVA and central macular thickness (CMT) at 6 months. RESULTS: Twenty-nine patients completed the study. After 3 months, BCVA improved by a mean +/- standard deviation (SD) of 16 +/- 14 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the ranibizumab group (n = 15), compared with a mean loss of 5 +/- 15 ETDRS letters in the sham group (n = 14; P = .001). The mean +/- SD change in CMT was -411 +/- 200 microm in the ranibizumab group and -86 +/- 165 microm with sham (P < .001). At 6 months, the mean +/- SD change in BCVA was 12 +/- 20 ETDRS letters in the ranibizumab group compared with -1 +/- 17 ETDRS letters in the sham group (P = .067). The mean +/- SD change in CMT was -304 +/- 194 microm with ranibizumab and -151 +/- 205 microm with sham (P = .05). Twelve patients (80%) in the ranibizumab group required more than 3 initial injections; mean +/- SD number of injections was 4.3 +/- 0.9 during the study. CONCLUSION: Monthly ranibizumab significantly increased BCVA and decreased macular edema, compared with sham, in patients with CRVO. Repeated consecutive injections are necessary to maintain initial positive results.
Assuntos
Inibidores da Angiogênese/administração & dosagem , Anticorpos Monoclonais/administração & dosagem , Edema Macular/tratamento farmacológico , Oclusão da Veia Retiniana/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Injeções , Edema Macular/etiologia , Edema Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ranibizumab , Oclusão da Veia Retiniana/complicações , Oclusão da Veia Retiniana/fisiopatologia , Retratamento , Resultado do Tratamento , Acuidade Visual/fisiologia , Corpo VítreoRESUMO
PURPOSE: To evaluate the incidence of posterior capsule opacification after implantation of two different intraocular lenses (IOLs), AcrySof and Stabibag, by comparing the neodymium:YAG (Nd:YAG) laser capsulotomy rates. METHODS: The medical records of 596 patients (705 eyes) who underwent phacoemulsification and posterior chamber IOL implantation using either AcrySof (n = 335) or Stabibag (n = 370) IOLs during a 1-year (1999) period were reviewed. Eyes with secondary cataract, combined procedures or operative complications, such as capsule tears, were excluded from the study. The subjects' age, sex, surgeon (two surgeons), and time for Nd:YAG laser capsulotomy were recorded. RESULTS: The mean follow-up was 23 months in both IOL groups. There were no statistically significant differences within the two IOL groups regarding sex distribution or surgeon. The mean age in the AcrySof group was 77.0 years compared to 79.2 years in the Stabibag group (p = 0.001). Nd:YAG laser capsulotomy was performed in 7.6% of patients in the Stabibag group compared to 2.7% in the AcrySof group (i.e. at a significantly higher rate) (p = 0.004). Survival analyses demonstrated that age and type of IOL were the only independent predictors of the incidence of capsulotomy. CONCLUSIONS: This study shows that the frequency of eyes with posterior capsule opacification needing capsulotomy was significantly higher in eyes with Stabibag IOLs compared to eyes with AcrySof IOLs.