PURPOSE: To determine the outcomes of a modified amniotic membrane transplantation (AMT) suturing technique for pain and discomfort relief in patients with symptomatic bullous keratopathy (BK). DESIGN: Randomized, double-blind controlled clinical trial. METHODS: setting: Ankara Research and Training Hospital 1st and 2nd Eye Clinics, Ankara, Turkey. study population: This prospective study included 39 eyes (39 patients) with BK presenting with intractable pain or discomfort and poor visual potential. intervention: Patients were randomly assigned into two groups: in group 1 (21 patients), patients underwent a modified AMT suturing technique; a groove was prepared by vacuum trephine on the recipient cornea and the edges of the punch-shaped amniotic membrane (AM) were sutured to this groove with the basement membrane side up. In group 2 (18 patients), patients underwent the standard AMT suturing to the cornea. main outcome measure: During a mean follow-up of 27.3 +/- 8.5 months (standard deviation) (range, 12 to 36 months), epithelial healing, persistence of AM, pain relief, and visual changes were analyzed and were compared between groups. RESULTS: The mean age (P = .15), the mean follow-up (P = .73), and the mean preoperative visual acuity (P = .53) were similar in both groups. With the modified suturing technique, the postoperative visual acuity was better (P = .03), epithelialization time was shorter (P < .001), and the AM remained longer (P < .001). Successful epithelialization was achieved in 20 eyes (95.3%) in group 1, and in 16 eyes (88.9%) in group 2 (P = .586). The pain scores of patients in group 1 remained stable (P = .223) over time, however increased from the first week to the third month postoperatively in group 2 (P = .046). CONCLUSIONS: The modified AMT suturing technique has a similar epithelialization rate to standard AMT suturing to cornea. Though technically more demanding, shorter epithelialization time, longer persistence of AM, andstable pain scores in the postoperative period makes this a promising method for the treatment of symptomatic BK.
RCT Entities:
PURPOSE: To determine the outcomes of a modified amniotic membrane transplantation (AMT) suturing technique for pain and discomfort relief in patients with symptomatic bullous keratopathy (BK). DESIGN: Randomized, double-blind controlled clinical trial. METHODS: setting: Ankara Research and Training Hospital 1st and 2nd Eye Clinics, Ankara, Turkey. study population: This prospective study included 39 eyes (39 patients) with BK presenting with intractable pain or discomfort and poor visual potential. intervention: Patients were randomly assigned into two groups: in group 1 (21 patients), patients underwent a modified AMT suturing technique; a groove was prepared by vacuum trephine on the recipient cornea and the edges of the punch-shaped amniotic membrane (AM) were sutured to this groove with the basement membrane side up. In group 2 (18 patients), patients underwent the standard AMT suturing to the cornea. main outcome measure: During a mean follow-up of 27.3 +/- 8.5 months (standard deviation) (range, 12 to 36 months), epithelial healing, persistence of AM, pain relief, and visual changes were analyzed and were compared between groups. RESULTS: The mean age (P = .15), the mean follow-up (P = .73), and the mean preoperative visual acuity (P = .53) were similar in both groups. With the modified suturing technique, the postoperative visual acuity was better (P = .03), epithelialization time was shorter (P < .001), and the AM remained longer (P < .001). Successful epithelialization was achieved in 20 eyes (95.3%) in group 1, and in 16 eyes (88.9%) in group 2 (P = .586). The pain scores of patients in group 1 remained stable (P = .223) over time, however increased from the first week to the third month postoperatively in group 2 (P = .046). CONCLUSIONS: The modified AMT suturing technique has a similar epithelialization rate to standard AMT suturing to cornea. Though technically more demanding, shorter epithelialization time, longer persistence of AM, and stable pain scores in the postoperative period makes this a promising method for the treatment of symptomatic BK.