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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856141

Enrollment

Registered

2009-03-05

Start date

2006-01-31

Completion date

2006-05-31

Last updated

2009-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Keywords

IOP measurement, IOP fluctuation, in-vivo IOP measuring device, intraocular pressure measurement

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.

Interventions

DEVICEphacoemulsifcation

A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
IOP fluctuation during each phase of surgery	intra-operative

Secondary

Measure	Time frame
comparison of IOP fluctuations between high and low parameters group	intra-operative

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026