Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedAugust 14, 2012
August 1, 2012
5 months
August 10, 2012
August 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Corneal clarity on postoperative day 1
postoperative day 1
Secondary Outcomes (1)
Central corneal thickness on postoperative day 1 and week 1
day 1 and week 1
Study Arms (3)
DiscoVisc
ACTIVE COMPARATORmicrocoaxial phacoemulsification performed with discovisc
Healon 5
ACTIVE COMPARATORmicrocoaxial phacoemulsification using healon 5
Celoftal
ACTIVE COMPARATORmicrocoaxial phacoemulsification using celoftal
Interventions
Eligibility Criteria
You may qualify if:
- Age related, uncomplicated senile cataracts
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iladevi Cataract & IOL Research Centre
Ahmedabad, Gujarat, 380052, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 14, 2012
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
August 14, 2012
Record last verified: 2012-08