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Completed

NCT Number: NCT00856141

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

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.

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Key information

Conditions

Intraocular Pressure

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raghudeep Eye Clinic

Ahmedabad, Gujarat, 52, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

phacoemulsifcation

Device

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

Primary outcomes

  1. IOP fluctuation during each phase of surgery

    Time frame: intra-operative

Secondary outcomes

  1. comparison of IOP fluctuations between high and low parameters group

    Time frame: intra-operative

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 5, 2009
Registry last updated
Mar 5, 2009

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.

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