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Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

This study has been completed.
Information provided by (Responsible Party):
Iladevi Cataract and IOL Research Center Identifier:
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Central corneal thickness on postoperative day 1 and week 1 [ Time Frame: day 1 and week 1 ]

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


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01664689

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

Responsible Party: Iladevi Cataract and IOL Research Center Identifier: NCT01664689     History of Changes
Other Study ID Numbers: OVD12
Study First Received: August 10, 2012
Last Updated: August 13, 2012

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on July 24, 2017