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NCT00856141 Clinical Trial

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

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00856141
Other study ID # 005-036
Secondary ID IOP set upIOP fl
Status Completed
Phase N/A
First received March 4, 2009
Last updated March 4, 2009
Start date January 2006
Est. completion date May 2006

Study information
Verified date March 2009
Source Iladevi Cataract and IOL Research Center
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 2006
Est. primary completion date March 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
India Raghudeep Eye Clinic Ahmedabad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

References & Publications (5)

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. Epub 2006 Dec 18. — View Citation

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. — View Citation

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. — View Citation

Khng C, Packer M, Fine IH, Hoffman RS, Moreira FB. Intraocular pressure during phacoemulsification. J Cataract Refract Surg. 2006 Feb;32(2):301-8. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary IOP fluctuation during each phase of surgery intra-operative Yes
Secondary comparison of IOP fluctuations between high and low parameters group intra-operative Yes
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