Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

NCT ID: NCT01387620

Last Updated: 2011-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Corneal Edema Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo - Fellow

Locations

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University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Espindola RF, Castro EF, Santhiago MR, Kara-Junior N. A clinical comparison between DisCoVisc and 2% hydroxypropylmethylcellulose in phacoemulsification: a fellow eye study. Clinics (Sao Paulo). 2012 Sep;67(9):1059-62. doi: 10.6061/clinics/2012(09)13.

Reference Type DERIVED
PMID: 23018304 (View on PubMed)

Other Identifiers

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USP - 0111 - 09

Identifier Type: -

Identifier Source: org_study_id

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