CClinicalTrials.gg
CompletedNCT01387620Updated Jul 4, 2011

Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%

A Phase 4 interventional study of Hyaluronic Acid and hydroxypropylmethylcellulose in Corneal Edema and Intraocular Pressure, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-07-04.

Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Corneal Edema
  • Intraocular Pressure

Browse trials for

Keywords

  • Phacoemulsification
  • Corneal Edema
  • Corneal Endothelium
  • Viscoelastic Substances
03

In context

Corneal Edema

45 studies on the registry are indexed under Corneal Edema; 7 are open to participants now.

This study's enrollment of 39 is close to the median of 42 across 37 interventional studies indexed under Corneal Edema.

Browse Corneal Edema studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Interventions

  • DrugHyaluronic Acid and hydroxypropylmethylcellulose

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

06

What researchers measure

Primary outcomes

  1. Corneal endothelial cell count

    Time frame: 6 months

Secondary outcomes

  1. Central Corneal Thickness

    Time frame: 7 days

07

Study locations

1 site
  • University of São Paulo
    São Paulo, 05403-000, Brazil
08

References and documents

Publications

  • 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. PubMed 23018304 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01387620
Lead sponsor
University of Sao Paulo
First posted
Jul 4, 2011
Start date
Jun 2009
Primary completion
Feb 2010
Completion
Dec 2010
Last update
Jul 4, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion