NCT00856141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
Last Updated

March 5, 2009

Status Verified

March 1, 2009

Enrollment Period

2 months

First QC Date

March 4, 2009

Last Update Submit

March 4, 2009

Conditions

Intraocular Pressure

Keywords

IOP measurementIOP fluctuationin-vivo IOP measuring deviceintraocular pressure measurement

Outcome Measures

Primary Outcomes (1)

  • IOP fluctuation during each phase of surgery

    intra-operative

Secondary Outcomes (1)

  • comparison of IOP fluctuations between high and low parameters group

    intra-operative

Study Arms (2)

1. High fluidic parameters

EXPERIMENTAL

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

Device: phacoemulsifcation

2. Low fluidic parameters

ACTIVE COMPARATOR

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

Device: phacoemulsifcation

Interventions

phacoemulsifcationDEVICE

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

Also known as: high aspiration flow rate,, high vacuum
1. High fluidic parameters

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing phacoemulsification for uncomplicated senile cataracts
  • Cataracts from grade 1 to 3

You may not qualify if:

  • presence of glaucoma,
  • diabetic retinopathy,
  • retinal vascular disease,
  • high myopia (defined as AL \> 25mm),
  • uveitis,
  • previous ocular trauma or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raghudeep Eye Clinic

Ahmedabad, Gujarat, 52, India

Location

Related Publications (5)

  • 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.

    PMID: 12757089BACKGROUND

  • 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.

    PMID: 17222793BACKGROUND

  • 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.

    PMID: 16565009BACKGROUND

  • 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.

    PMID: 16286613BACKGROUND

  • 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.

    PMID: 10209431BACKGROUND

Study Officials

  • Abhay R Vasavada, FRCS

    Iladevi Cataract and IOL Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

January 1, 2006

Primary Completion

March 1, 2006

Study Completion

May 1, 2006

Last Updated

March 5, 2009

Record last verified: 2009-03

Locations

IN(1)