Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

Intraocular Pressure Clinical Trial

Official title:

Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387620
• Other study ID #: USP - 0111 - 09
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2011
• Last updated: June 30, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Bilateral age-related cataract

• Grade 1-3 lens opacities classification system (LOCS III)

• Pupil dilatation greater than 7.0 mm

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Edema
• Intraocular Pressure

Intervention

Drug:
• Hyaluronic Acid and hydroxypropylmethylcellulose
Hyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye.

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelial cell count		6 months	Yes
Secondary	Central Corneal Thickness		7 days	Yes