Clinical trial NCT00856141: Set up for in-Vivo Measurement of Dynamic Intraocular Pressure (IOP)
Official title: In Vivo Evaluation of Dynamic IOP Measuring Device During Phacoemulsifcation: A Prospective Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Keywords: IOP measurement
IOP fluctuation
in-vivo IOP measuring device
intraocular pressure measurement
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: IOP fluctuation during each phase of surgery
timeFrame: intra-operative
Secondary outcomes:
measure: comparison of IOP fluctuations between high and low parameters group
timeFrame: intra-operative
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Raghudeep Eye Clinic
state: Gujarat
Study officials:
affiliation: Iladevi Cataract and IOL Research Center
name: Abhay R Vasavada, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1016/j.jcrs.2005.08.062.
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. doi: 10.1001/archopht.123.11.1514.
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. doi: 10.1136/bjo.83.1.33.