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Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

Primary Purpose

Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Microcoaxial Phacoemulsification
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Iladevi Cataract & IOL Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

DiscoVisc

Healon 5

Celoftal

Arm Description

microcoaxial phacoemulsification performed with discovisc

microcoaxial phacoemulsification using healon 5

microcoaxial phacoemulsification using celoftal

Outcomes

Primary Outcome Measures

Corneal clarity on postoperative day 1

Secondary Outcome Measures

Central corneal thickness on postoperative day 1 and week 1

Full Information

First Posted
August 10, 2012
Last Updated
August 13, 2012
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01664689
Brief Title
Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DiscoVisc
Arm Type
Active Comparator
Arm Description
microcoaxial phacoemulsification performed with discovisc
Arm Title
Healon 5
Arm Type
Active Comparator
Arm Description
microcoaxial phacoemulsification using healon 5
Arm Title
Celoftal
Arm Type
Active Comparator
Arm Description
microcoaxial phacoemulsification using celoftal
Intervention Type
Procedure
Intervention Name(s)
Microcoaxial Phacoemulsification
Primary Outcome Measure Information:
Title
Corneal clarity on postoperative day 1
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
Central corneal thickness on postoperative day 1 and week 1
Time Frame
day 1 and week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India

12. IPD Sharing Statement

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Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

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