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

Iladevi Cataract and IOL Research Center

Status: Completed

Conditions: Intraocular Pressure

Treatments: Device: phacoemulsifcation

Study type: Interventional

Funder types: Other

Identifiers

NCT00856141

IOP fluctuations

IOP set up

005-036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1. High fluidic parameters

Experimental group

Description:

Bottle height varied from 90-110cms, fixed aspiration flow rate 40cc/min, vacuum upto 650mmHg depending on the grade of cataract

Treatment:

Device: phacoemulsifcation

Device: phacoemulsifcation

2. Low fluidic parameters

Active Comparator group

Description:

Bottle height varied from 70-90cms, fixed aspiration flow rate of 25cc/min, vacuum upto 400mmHg, depending on the grade of cataract

Treatment:

Device: phacoemulsifcation

Device: phacoemulsifcation