Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

Phase 4

Completed

• Conditions: Corneal Edema; Intraocular Pressure

• Registration Number: NCT01387620
• Lead Sponsor: University of Sao Paulo

Brief Summary

This prospective study was performed to compare two ophthalmic viscosurgical devices, DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose 2% in terms of their overall clinical performance during phacoemulsification.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-02
• Status Verified: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-30
• Last Update Submitted: 2011-06-30
• Study First Posted: 2011-07-04
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Bilateral age-related cataract
• Grade 1-3 lens opacities classification system (LOCS III)
• Pupil dilatation greater than 7.0 mm

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Exclusion Criteria

• Black, brunescent, traumatic or subluxated cataract
• Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3)
• Glaucoma, uveitis
• Previous ocular surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Corneal endothelial cell count	6 months

Secondary Outcome Measures

Name	Time	Method
Central Corneal Thickness	7 days

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil