IOP Changes Associated With SICS and Phako
- Conditions
- CataractGlaucoma
- Interventions
- Procedure: cataract surgery
- Registration Number
- NCT02642211
- Lead Sponsor
- Robin, Alan L., M.D.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Age over 40 requiring cataract surgery -
inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MSICS cataract surgery Eyes undergoing manual small incision cataract surgery phako cataract surgery eyes receiving phakoemulsification for cataract surgery
- Primary Outcome Measures
Name Time Method Intraocular pressure lowering 6 months intraocular pressure measured with aplanation tonometry
- Secondary Outcome Measures
Name Time Method Angle anatomy 6 months OCT changes in angle anatomy