Anterior ciliary sclerotomy for treatment of presbyopia: a prospective controlled study.

PURPOSE: To examine the safety and efficacy of anterior ciliary sclerotomy to restore accommodation in the presbyopic eye. DESIGN: Prospective nonrandomized comparative single-center clinical trial. PARTICIPANTS: Nine presbyopic subjects with no prior ocular surgery except corneal refractive procedures were enrolled. METHODS: One eye from each subject was chosen, in consultation with the patient, to undergo anterior ciliary sclerotomy. The contralateral eye of each subject served as a control. Examinations were performed preoperatively, and at 1 day, 1 week, 1 month, and 6 months after surgery. MAIN OUTCOME MEASURES: (1) Accommodative amplitude, measured by two methods, (2) Jaeger reading vision at 14 inches wearing best distance correction, (3) manifest refraction, (4) assessment of operative complications. RESULTS: For the nine study eyes, there was no statistically significant change between the average accommodative amplitude at the preoperative visit (1.11 diopter [D]) and the 1-month postoperative visit (1.19 D, P = 0.55) nor at the 6-month postoperative visit (1.31 D, P = 0.21) in the study eyes. There was no significant difference between the study and control eyes' change in accommodative amplitude at 6 months (P = 0.43). Logarithm of the minimum angle of resolution equivalent of Jaeger reading vision in the study eyes at 14 inches wearing best distance correction showed no statistically significant change from the preoperative visit (0.53 [20/70]) at the 1-month postoperative visit (0.41 [20/50], P = 0.07) or at the 6-month postoperative visit (0.48 [20/60], P = 0.22). There was no significant change in manifest refraction spherical equivalent in the study eyes at 1 and 6 months postoperatively. One eye experienced a perforation of the anterior chamber during surgery. A second eye experienced mild postoperative anterior segment ischemia manifested by sectoral iris akinesis. CONCLUSIONS: Anterior ciliary sclerotomy does not restore accommodation in presbyopic eyes and can cause significant complications.