IOP Changes Associated With SICS and Phako

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

Completed

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Key information

Conditions

Cataract Eye Diseases Glaucoma Lens Diseases Ocular Hypertension

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age over 40 requiring cataract surgery -

Exclusion criteria

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

Treatment and study plan

cataract surgery

Procedure

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

Primary outcomes

Intraocular pressure lowering

Time frame: 6 months

intraocular pressure measured with aplanation tonometry

Secondary outcomes

Angle anatomy

Time frame: 6 months

OCT changes in angle anatomy

Sponsors and collaborators

Lead sponsor

Robin, Alan L., M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Dec 30, 2015
Registry last updated: Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed