CataractPhase 4NCT00763360

To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

A Phase 4 study testing DisCoVisc®, Healon and Amvisc Plus in people with Cataract, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery. Read more about this study

Who is it for?: Ages 49 years and older
Conditions the study is for: Cataract
What is being tested?: DisCoVisc®, Healon and Amvisc Plus
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 1 siteUnited States
Study dates: May 2008to Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 49 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients able to understand and sign a document of informed consent;
Patients aged ≥49 years with age-related cataract formation;
Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
Patients that have healthy eyes excluding the formation of cataract.

Who cannot join

pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
Iris atrophy in the operative eye;
Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;

Show all 19Show fewer

Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
Patients 48 years of age or younger;
Proliferative diabetic retinopathy in the operative eye;
Uncontrolled diabetes mellitus;
Marfan's Syndrome;
An ocular disease and/or condition that may compromise results;
A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
Lens for the correction of astigmatism may be performed;
Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
A non-functional fellow eye;
Participation in any other clinical study within the 30 days before surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Call Center
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

Conditions: Cataract
Being tested: DisCoVisc®, Healon, Amvisc Plus
Keywords: Cataract
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DisCoVisc®Device
Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
HealonDrug
Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
Amvisc PlusDrug
Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Study groups in NCT00763360
Study group	Role	What they receive
DisCoVisc®	Experimental	DisCoVisc® Ophthalmic Viscosurgical Device Receives: Device: DisCoVisc®
Healon	Active comparator	Healon Receives: Drug: Healon
Amvisc Plus	Active comparator	Amvisc Plus Receives: Drug: Amvisc Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

Endothelial Cell Count Change From Baseline
Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
Measured: one month
Investigator Reported Space Maintenance
Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.
Measured: During surgical procedure

Secondary outcomes (2)

Change in Corneal Thickness
Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
Measured: 1 month
Corneal Clarity
Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Sep 2010

First posted30 Sep 2008 (estimated)
Study startMay 2008
Primary completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763360
Sponsor's protocol ID: AUS-S-07-01
Status last verified: Dec 2011
First submitted: 26 Sep 2008
Last updated: 24 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.
ClinicalTrials.gov ID: NCT00763360
Acronym / sponsor ID: AUS-S-07-01
Conditions: Cataract
Keywords: Cataract
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Sep 2010 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 24 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
DisCoVisc®	Experimental	Device: DisCoVisc®DisCoVisc® Ophthalmic Viscosurgical Device
Healon	Active comparator	Drug: HealonHealon
Amvisc Plus	Active comparator	Drug: Amvisc PlusAmvisc Plus

Who may qualify

Ages: 49 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients able to understand and sign a document of informed consent;
Patients aged ≥49 years with age-related cataract formation;
Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
Patients that have healthy eyes excluding the formation of cataract.

Key exclusion criteria (19 listed)

pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
Iris atrophy in the operative eye;
Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;

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
DisCoVisc®Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure	Device	DisCoVisc®
HealonInjection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure	Drug	Healon
Amvisc PlusInjection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure	Drug	Amvisc Plus

Primary outcome

Endothelial Cell Count Change From Baseline
Time frame: one month
Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
Investigator Reported Space Maintenance
Time frame: During surgical procedure
Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.

2 secondary outcomes

Change in Corneal Thickness
Time frame: 1 month
Corneal Clarity
Time frame: 2 weeks

Results and safety

Results posted to the registry on 24 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DisCoVisc®	61	61
Healon	60	58
Amvisc Plus	63	63

Primary outcome: Endothelial Cell Count Change From Baseline

Time frame: one month. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	DisCoVisc® n = 57	Healon n = 58	Amvisc Plus n = 61
Value	-7.91 (16.49)	-5.11 (19.41)	-4.92 (13.89)

Population analysed: Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.

Primary outcome: Investigator Reported Space Maintenance

Time frame: During surgical procedure. Number. Unit: participants

Measure	DisCoVisc® n = 61	Healon n = 58	Amvisc Plus n = 61
Capsulorhexis - full chamber maintained	59	26	61
Capsulorhexis - working space maintained	2	26	1
Capsulorhexis - shallow	0	5	1
Capsulorhexis - flat	0	1	0
Hydrodissection - full chamber maintained	52	10	45
Hydrodissection - working space maintained	8	22	10
Hydrodissection - shallow	1	16	6
Hydrodissection - flat	0	10	2

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DisCoVisc®	0 of 61 (0%)	0 of 61 (0%)	Not reported
Healon	0 of 60 (0%)	0 of 60 (0%)	Not reported
Amvisc Plus	0 of 63 (0%)	0 of 63 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

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Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
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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 DisCoVisc®, Healon and Amvisc Plus in people with Cataract, run by Alcon Research at 1 site in United States.

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 4 inclusion and 19 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 24 Jan 2012. 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Endothelial Cell Count Change From Baseline (time frame: one month). The study lists 2 primary outcomes in all. 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 NCT00763360.

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 24 Jan 2012.