Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

Not Applicable

Completed

• Conditions: Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
• Interventions: Procedure: Microcoaxial Phacoemulsification

• Registration Number: NCT01664689
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-13
• Last Update Submitted: 2012-08-13
• Study First Posted: 2012-08-14
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DiscoVisc	Microcoaxial Phacoemulsification	microcoaxial phacoemulsification performed with discovisc
Healon 5	Microcoaxial Phacoemulsification	microcoaxial phacoemulsification using healon 5
Celoftal	Microcoaxial Phacoemulsification	microcoaxial phacoemulsification using celoftal

Primary Outcome Measures

Name	Time	Method
Corneal clarity on postoperative day 1	postoperative day 1

Secondary Outcome Measures

Name	Time	Method
Central corneal thickness on postoperative day 1 and week 1	day 1 and week 1

Trial Locations

Locations (1)

Iladevi Cataract & IOL Research Centre; 🇮🇳 Ahmedabad, Gujarat, India