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CME With Different Fluidic Parameters

NCT01385852 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-06-06

No results posted yet for this study

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

Conditions

  • Cystoid Macular Edema Following Cataract Surgery

Interventions

PROCEDURE

microcoaxial phacoemulsification

conventional longitudinal ultrasound

Sponsors & Collaborators

  • Iladevi Cataract and IOL Research Center

    lead OTHER

Principal Investigators

  • ABHAY R VASAVADA, MS, FRCS · ILADEVI CATARACT AND RESEARCH CENTER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-02-28
Completion
2011-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385852 on ClinicalTrials.gov