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

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT00856141
First received: March 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Intraocular Pressure
Device: phacoemulsifcation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Vivo Evaluation of Dynamic IOP Measuring Device During Phacoemulsifcation: A Prospective Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • IOP fluctuation during each phase of surgery [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • comparison of IOP fluctuations between high and low parameters group [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • high aspiration flow rate,
  • high vacuum
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856141

Locations
India
Raghudeep Eye Clinic
Ahmedabad, Gujarat, India, 52
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Abhay R Vasavada, FRCS Iladevi Cataract and IOL Research Center
  More Information

Additional Information:
Publications:
Responsible Party: DR. SHETAL RAJ, ICIRC
ClinicalTrials.gov Identifier: NCT00856141     History of Changes
Other Study ID Numbers: 005-036, IOP set up, IOP fluctuations
Study First Received: March 4, 2009
Last Updated: March 4, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:
IOP measurement
IOP fluctuation
in-vivo IOP measuring device
intraocular pressure measurement

ClinicalTrials.gov processed this record on November 20, 2014