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Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01664689
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
 Procedure: Microcoaxial Phacoemulsification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • Corneal clarity on postoperative day 1 [ Time Frame: postoperative day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central corneal thickness on postoperative day 1 and week 1 [ Time Frame: day 1 and week 1 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DiscoVisc
microcoaxial phacoemulsification performed with discovisc
 Procedure: Microcoaxial Phacoemulsification
Active Comparator: Healon 5
microcoaxial phacoemulsification using healon 5
 Procedure: Microcoaxial Phacoemulsification
Active Comparator: Celoftal
microcoaxial phacoemulsification using celoftal
 Procedure: Microcoaxial Phacoemulsification

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664689

Locations
India
Iladevi Cataract & IOL Research Centre
Ahmedabad, Gujarat, India, 380052
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
  More Information

No publications provided

Responsible Party: Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT01664689     History of Changes
Other Study ID Numbers: OVD12
Study First Received: August 10, 2012
Last Updated: August 13, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013