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Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

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ClinicalTrials.gov Identifier: NCT01664689
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Iladevi Cataract and IOL Research Center

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

Condition or disease Intervention/treatment Phase
Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery Procedure: Microcoaxial Phacoemulsification Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Corneal clarity on postoperative day 1 [ Time Frame: postoperative day 1 ]

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


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664689


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

Responsible Party: Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT01664689     History of Changes
Other Study ID Numbers: OVD12
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases