NCT01387620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
Last Updated

July 4, 2011

Status Verified

December 1, 2010

Enrollment Period

8 months

First QC Date

June 28, 2011

Last Update Submit

June 30, 2011

Conditions

Corneal EdemaIntraocular Pressure

Keywords

PhacoemulsificationCorneal EdemaCorneal EndotheliumViscoelastic Substances

Outcome Measures

Primary Outcomes (1)

  • Corneal endothelial cell count

    6 months

Secondary Outcomes (1)

  • Central Corneal Thickness

    7 days

Interventions

Hyaluronic Acid and hydroxypropylmethylcelluloseDRUG

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

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23018304DERIVED

MeSH Terms

Conditions

Corneal Edema

Interventions

Hyaluronic AcidHypromellose Derivatives

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCelluloseGlucansBiopolymersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 4, 2011

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Study Completion

December 1, 2010

Last Updated

July 4, 2011

Record last verified: 2010-12

Locations

BR(1)