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

Not Applicable

Completed

• Conditions: Intraocular Pressure
• Interventions: Device: phacoemulsifcation

• Registration Number: NCT00856141
• Lead Sponsor: Iladevi Cataract and IOL Research Center

Brief Summary

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.

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2006-03
• Study Completion: 2006-05
• Status Verified: 2009-03
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Last Update Submitted: 2009-03-04
• Study First Posted: 2009-03-05
• Last Update Posted: 2009-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. High fluidic parameters	phacoemulsifcation	Bottle height varied from 90-110cms, fixed aspiration flow rate 40cc/min, vacuum upto 650mmHg depending on the grade of cataract
2. Low fluidic parameters	phacoemulsifcation	Bottle height varied from 70-90cms, fixed aspiration flow rate of 25cc/min, vacuum upto 400mmHg, depending on the grade of cataract

Primary Outcome Measures

Name	Time	Method
IOP fluctuation during each phase of surgery	intra-operative

Secondary Outcome Measures

Name	Time	Method
comparison of IOP fluctuations between high and low parameters group	intra-operative

Trial Locations

Locations (1)

Raghudeep Eye Clinic; 🇮🇳 Ahmedabad, Gujarat, India