IOP Changes Associated With SICS and Phako

Early Phase 1CompletedNCT02642211

Robin, Alan L., M.D.500 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

500

Conditions

Cataract Glaucoma

Interventions

cataract surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria:Age over 40 requiring cataract surgery - Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma \-

Outcomes

Primary Outcomes

Intraocular pressure lowering

intraocular pressure measured with aplanation tonometry

Time frame: 6 months

Secondary Outcomes

Angle anatomy

OCT changes in angle anatomy

Time frame: 6 months

Data from ClinicalTrials.gov

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