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NCT02642211 Clinical Trial

IOP Changes Associated With SICS and Phako

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02642211
Other study ID # SICS_Phaco_1
Secondary ID
Status Completed
Phase Phase 0
First received December 19, 2015
Last updated January 5, 2016
Start date January 2014
Est. completion date September 2015

Study information
Verified date December 2015
Source Robin, Alan L., M.D.
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Completed
Enrollment 500
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:Age over 40 requiring cataract surgery -

Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Robin, Alan L., M.D.

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure lowering intraocular pressure measured with aplanation tonometry 6 months No
Secondary Angle anatomy OCT changes in angle anatomy 6 months No
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