OBJECTIVE: To determine whether there is a statistically significant difference in the surgical outcome of everting sutures (ES) alone versus everting sutures with a lateral tarsal strip (ES+LTS) in the treatment of involutional entropion. DESIGN: Prospective randomized comparative trial. PARTICIPANTS: Sixty-three patients with primary involutional lower eyelid entropion were enrolled in the study. The age range was 54 to 94 years, with a mean age of 77 years. Baseline characteristics of the comparative groups were similar. METHODS:Patients requiring primary surgical repair for involutional entropion were selected, and those providing informed consent were randomized for surgery. Thirty-six patients were randomized to ES alone, and 27 patients were randomized to ES+LTS. Patients were evaluated at 3 weeks and 6, 12, and 18 months postoperatively. MAIN OUTCOME MEASURES: Successful surgery was defined as a normal eyelid position at rest and inability to induce entropion on tetracaine provocation testing at or before the 18-month follow-up visit. RESULTS: Eight patients were lost to follow-up (7 had ES alone). Of the 55 patients with complete follow-up data, there were 6 failed procedures in the patients who underwent ES alone and no failed procedures in the patients who underwent ES+LTS (P = 0.02). CONCLUSIONS: These data provide strong evidence that success rates at 18 months are higher in patients treated with ES+LTS procedure compared with ES alone. Copyright (c) 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
RCT Entities:
OBJECTIVE: To determine whether there is a statistically significant difference in the surgical outcome of everting sutures (ES) alone versus everting sutures with a lateral tarsal strip (ES+LTS) in the treatment of involutional entropion. DESIGN: Prospective randomized comparative trial. PARTICIPANTS: Sixty-three patients with primary involutional lower eyelid entropion were enrolled in the study. The age range was 54 to 94 years, with a mean age of 77 years. Baseline characteristics of the comparative groups were similar. METHODS:Patients requiring primary surgical repair for involutional entropion were selected, and those providing informed consent were randomized for surgery. Thirty-six patients were randomized to ES alone, and 27 patients were randomized to ES+LTS. Patients were evaluated at 3 weeks and 6, 12, and 18 months postoperatively. MAIN OUTCOME MEASURES: Successful surgery was defined as a normal eyelid position at rest and inability to induce entropion on tetracaine provocation testing at or before the 18-month follow-up visit. RESULTS: Eight patients were lost to follow-up (7 had ES alone). Of the 55 patients with complete follow-up data, there were 6 failed procedures in the patients who underwent ES alone and no failed procedures in the patients who underwent ES+LTS (P = 0.02). CONCLUSIONS: These data provide strong evidence that success rates at 18 months are higher in patients treated with ES+LTS procedure compared with ES alone. Copyright (c) 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Authors: Harrison Dermer; Daniella Lent-Schochet; Despoina Theotoka; Christian Paba; Abdullah A Cheema; Ryan S Kim; Anat Galor Journal: Drugs Date: 2020-04 Impact factor: 9.546