Set up for in-Vivo Measurement of Dynamic Intraocular Pressure (IOP)

March 4, 2009 updated by: Iladevi Cataract and IOL Research Center

In Vivo Evaluation of Dynamic IOP Measuring Device During Phacoemulsifcation: A Prospective Randomised Clinical Trial

In this modern era, surgeons prefer to perform emulsification through small micro incisions. To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion systems.We believe that this sustained rise in the IOP during micro-incision phacoemulsification for a substantial period could be detrimental to the ocular structures. Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging concern.

Conventional systems for measuring IOP generate an isolated graph of continuous pressure recording. Interpretation of the IOP fluctuations from these graphs requires a two step superimposition approach to characterize the IOP changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study was to describe a new setup for intra-operative monitoring of IOP in a clinical setting and validate it by correlating IOP differences arising with different phacoemulsification parameters in eyes undergoing microincision coaxial phacoemulsification.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 52
        • Raghudeep Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing phacoemulsification for uncomplicated senile cataracts
  • Cataracts from grade 1 to 3

Exclusion Criteria:

  • presence of glaucoma,
  • diabetic retinopathy,
  • retinal vascular disease,
  • high myopia (defined as AL > 25mm),
  • uveitis,
  • previous ocular trauma or surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. High fluidic parameters
Bottle height varied from 90-110cms, fixed aspiration flow rate 40cc/min, vacuum upto 650mmHg depending on the grade of cataract
Device: phacoemulsifcation
A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
Other Names:
  • low flow rate
  • low vacuum
  • low bottle height
Active Comparator: 2. Low fluidic parameters
Bottle height varied from 70-90cms, fixed aspiration flow rate of 25cc/min, vacuum upto 400mmHg, depending on the grade of cataract
Device: phacoemulsifcation
A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
Other Names:
  • low flow rate
  • low vacuum
  • low bottle height

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP fluctuation during each phase of surgery
Time Frame: intra-operative
intra-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
comparison of IOP fluctuations between high and low parameters group
Time Frame: intra-operative
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iladevi Cataract and IOL Research Center

Investigators

  • Principal Investigator: Abhay R Vasavada, FRCS, Iladevi Cataract and IOL Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

March 5, 2009

Last Update Submitted That Met QC Criteria

March 4, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 005-036
  • IOP set up
  • IOP fluctuations

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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