PURPOSE: To compare the efficacy and safety of phototherapeutic keratectomy (PTK) and amniotic membrane transplantation (AMT) for symptomatic relief in painful bullous keratopathy. METHODS:Twenty-five eyes of 25 patients with symptomatic bullous keratopathy and poor visual potential were randomized into 2 groups. In the PTK group (n = 13) after manual epithelial debridement, 100-microm excimer laser ablation was performed. In the AMT group (n = 12), the corneal epithelium was scraped and cryopreserved amniotic membrane with basement membrane side up was secured with 10-0 monofilament nylon sutures. All patients were followed up for at least 6 months. Outcome parameters included symptomatic relief, time taken for surface reepithelialization, change in corneal thickness, and complications. RESULTS: At 6-month follow-up, a significant decrease was seen in the symptom scores from the baseline level in both the PTK and AMT groups (P = 0.011 and 0.017, respectively) with no difference between the groups (P = 0.593). Complete epithelialization was noted 2 weeks postoperatively in 13 of 13 eyes in the PTK group as compared with 8 of 12 eyes in the AMT group (P = 0.023). However, this difference was not significant at the end of 3 weeks (P = 0.288). One eye in the AMT group developed Staphylococcus epidermidis keratitis. CONCLUSION: Both PTK and AMT are comparable in providing symptomatic relief in patients with bullous keratopathy and poor visual potential.
RCT Entities:
PURPOSE: To compare the efficacy and safety of phototherapeutic keratectomy (PTK) and amniotic membrane transplantation (AMT) for symptomatic relief in painful bullous keratopathy. METHODS: Twenty-five eyes of 25 patients with symptomatic bullous keratopathy and poor visual potential were randomized into 2 groups. In the PTK group (n = 13) after manual epithelial debridement, 100-microm excimer laser ablation was performed. In the AMT group (n = 12), the corneal epithelium was scraped and cryopreserved amniotic membrane with basement membrane side up was secured with 10-0 monofilament nylon sutures. All patients were followed up for at least 6 months. Outcome parameters included symptomatic relief, time taken for surface reepithelialization, change in corneal thickness, and complications. RESULTS: At 6-month follow-up, a significant decrease was seen in the symptom scores from the baseline level in both the PTK and AMT groups (P = 0.011 and 0.017, respectively) with no difference between the groups (P = 0.593). Complete epithelialization was noted 2 weeks postoperatively in 13 of 13 eyes in the PTK group as compared with 8 of 12 eyes in the AMT group (P = 0.023). However, this difference was not significant at the end of 3 weeks (P = 0.288). One eye in the AMT group developed Staphylococcus epidermidis keratitis. CONCLUSION: Both PTK and AMT are comparable in providing symptomatic relief in patients with bullous keratopathy and poor visual potential.