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Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

NCT ID: NCT01664689

Last Updated: 2012-08-14

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-03-31

Brief Summary

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Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs

Detailed Description

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Conditions

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Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DiscoVisc

microcoaxial phacoemulsification performed with discovisc

Group Type ACTIVE_COMPARATOR

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Healon 5

microcoaxial phacoemulsification using healon 5

Group Type ACTIVE_COMPARATOR

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Celoftal

microcoaxial phacoemulsification using celoftal

Group Type ACTIVE_COMPARATOR

Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Interventions

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Microcoaxial Phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age related, uncomplicated senile cataracts

Exclusion Criteria

* presence of glaucoma,
* shallow anterior chamber (ACD \< 2.1mm),
* pupillary dilatation \< 6mm,
* extremely dense cataracts,
* posterior polar cataract,
* subluxated cataract,
* white mature cataract,
* diabetic retinopathy,
* high myopia (defined as AL \> 25mm),
* uveitis, or
* previous ocular trauma/surgery.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, India

Site Status

Countries

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India

Other Identifiers

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OVD12

Identifier Type: -

Identifier Source: org_study_id