CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
microcoaxial phacoemulsificationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01385852
NCT01385852Phase 4Completed

Impact of Different Fluidic Parameters on Development of Cystoid Macular Edema Following Phacoemulsification

Iladevi Cataract and IOL Research Center·interventional·Posted Jun 30, 2011·Updated Jun 6, 2012

In Brief

A Phase 4 clinical trial evaluating microcoaxial phacoemulsification for Cystoid Macular Edema Following Cataract Surgery. Completed, enrolled 150 participants across 1 site.

Detailed Summary

Understanding and modulating fluid parameters is an important, but often overlooked aspect of phacoemulsification. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. The investigators found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability. Based on the results of this study, the investigators decided to take it further and study the impact of using high parameters (and thus, higher chamber instability) on macular edema and thickness following surgery, in an otherwise uncomplicated surgery. Higher fluid parameters during phacoemulsification predisposes the eye to increased macular thickness

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2011
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago

Interventions

microcoaxial phacoemulsificationprocedure

conventional longitudinal ultrasound