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

NCT ID: NCT00856141

Last Updated: 2009-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-05-31

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.

Conditions

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Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1. High fluidic parameters

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

Group Type EXPERIMENTAL

phacoemulsifcation

Intervention Type DEVICE

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

2. Low fluidic parameters

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

Group Type ACTIVE_COMPARATOR

phacoemulsifcation

Intervention Type DEVICE

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

Interventions

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phacoemulsifcation

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

Intervention Type DEVICE

phacoemulsifcation

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

Intervention Type DEVICE

Other Intervention Names

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high aspiration flow rate, high vacuum low flow rate low vacuum low bottle height

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role lead

Responsible Party

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ICIRC

Principal Investigators

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Abhay R Vasavada, FRCS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract and IOL Research Center

Locations

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Raghudeep Eye Clinic

Ahmedabad, Gujarat, India

Site Status

Countries

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India

References

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Grinbaum A, Blumenthal M, Assia E. Comparison of intraocular pressure profiles during cataract surgery by phacoemulsification and extracapsular cataract extraction. Ophthalmic Surg Lasers Imaging. 2003 May-Jun;34(3):182-6.

Reference Type BACKGROUND
PMID: 12757089 (View on PubMed)

Georgescu D, Payne M, Olson RJ. Objective measurement of postocclusion surge during phacoemulsification in human eye-bank eyes. Am J Ophthalmol. 2007 Mar;143(3):437-40. doi: 10.1016/j.ajo.2006.11.017. Epub 2006 Dec 18.

Reference Type BACKGROUND
PMID: 17222793 (View on PubMed)

Khng C, Packer M, Fine IH, Hoffman RS, Moreira FB. Intraocular pressure during phacoemulsification. J Cataract Refract Surg. 2006 Feb;32(2):301-8. doi: 10.1016/j.jcrs.2005.08.062.

Reference Type BACKGROUND
PMID: 16565009 (View on PubMed)

Moorhead LC, Gardner TW, Lambert HM, O'Malley RE, Willis AW, Meharg LS, Moorhead WD. Dynamic intraocular pressure measurements during vitrectomy. Arch Ophthalmol. 2005 Nov;123(11):1514-23. doi: 10.1001/archopht.123.11.1514.

Reference Type BACKGROUND
PMID: 16286613 (View on PubMed)

Joos KM, Kay MD, Pillunat LE, Harris A, Gendron EK, Feuer WJ, Steinwand BE. Effect of acute intraocular pressure changes on short posterior ciliary artery haemodynamics. Br J Ophthalmol. 1999 Jan;83(1):33-8. doi: 10.1136/bjo.83.1.33.

Reference Type BACKGROUND
PMID: 10209431 (View on PubMed)

Other Identifiers

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IOP set up

Identifier Type: -

Identifier Source: secondary_id

IOP fluctuations

Identifier Type: -

Identifier Source: secondary_id

005-036

Identifier Type: -

Identifier Source: org_study_id

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