NCT02642211

IOP Changes Associated With SICS and Phako

An Evaluation of Intraocular Pressure Reduction Following Phacoemulsification and Manual Small Incision Cataract Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Robin, Alan L., M.D. · Individual
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification

Detailed description

Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1 randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (ASOCT) were performed at baseline and at 1, 3 and 6 months follow up.

Conditions

• Cataract
• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	cataract surgery	Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-12-30
• Last updated: 2016-01-07