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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraocular Pressure

Intervention / Treatment
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* Device: phacoemulsifcation
* Device: phacoemulsifcation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOP measurement, IOP fluctuation, in-vivo IOP measuring device, intraocular pressure measurement