Corneal EdemaPhase 4NCT01387620
Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
A Phase 4 study testing Hyaluronic Acid and hydroxypropylmethylcellulose in people with Corneal Edema and Intraocular Pressure, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Corneal Edema, Intraocular Pressure
- What is being tested?
- Hyaluronic Acid and hydroxypropylmethylcellulose
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract
- Grade 1-3 lens opacities classification system (LOCS III)
- Pupil dilatation greater than 7.0 mm
Who cannot join
- Black, brunescent, traumatic or subluxated cataract
- Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3)
- Glaucoma, uveitis
- Previous ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification
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.
- Conditions
- Corneal Edema, Intraocular Pressure
- Being tested
- Hyaluronic Acid and hydroxypropylmethylcellulose
- Keywords
- Phacoemulsification, Corneal Edema, Corneal Endothelium, Viscoelastic Substances
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial cell count
Measured: 6 months
Secondary outcomes (1)
Central Corneal Thickness
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387620
- Sponsor's protocol ID
- USP - 0111 - 09
- Status last verified
- Dec 2010
- First submitted
- 28 Jun 2011
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification
- ClinicalTrials.gov ID
- NCT01387620
- Acronym / sponsor ID
- USP - 0111 - 09
- Conditions
- Corneal Edema, Intraocular Pressure
- Keywords
- Phacoemulsification, Corneal Edema, Corneal Endothelium, Viscoelastic Substances
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral age-related cataract
- Grade 1-3 lens opacities classification system (LOCS III)
- Pupil dilatation greater than 7.0 mm
Key exclusion criteria (4 listed)
- Black, brunescent, traumatic or subluxated cataract
- Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3)
- Glaucoma, uveitis
- Previous ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid and hydroxypropylmethylcelluloseHyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye. | Drug | – |
Primary outcome
Corneal endothelial cell count
Time frame: 6 months
1 secondary outcome
Central Corneal Thickness
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
- Derived from this study: PubMed 23018304Espindola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic Acid and hydroxypropylmethylcellulose in people with Corneal Edema and Intraocular Pressure, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal endothelial cell count (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01387620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.