Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL

NCT ID: NCT00855491

Last Updated: 2009-03-04

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

Detailed Description

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We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

Conditions

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Posterior Capsule Opacification

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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1. MYOPIA

axial length \> 26.00 mm

Group Type EXPERIMENTAL

Phaco

Intervention Type PROCEDURE

AcrySof Single-Piece IOL

2. Emmetropia

emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm

Group Type ACTIVE_COMPARATOR

Phaco

Intervention Type PROCEDURE

AcrySof Single-Piece IOL

Interventions

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Phaco

AcrySof Single-Piece IOL

Intervention Type PROCEDURE

Other Intervention Names

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emmetropic eyes normal axial length

Eligibility Criteria

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Inclusion Criteria

* local residency and presence of a cataract in an otherwise normal eye.
* Patients older than 50 years
* a dilated pupil after mydriasis
* Patients with retinochoroidal atrophy, retinal laser prophylaxis,
* hypertension

Exclusion Criteria

* nondilating pupil after maximal dilation;
* pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
* previous intraocular surgery;
* previous surgery for glaucoma;
* uveitis
* diabetes mellitus
* Patients who did not give consent preoperatively
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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ALPESH SHAH, MS

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

Other Identifiers

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03-009

Identifier Type: -

Identifier Source: org_study_id

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