CataractsPhase 3NCT00732225

DisCoVisc Comparative Evaluation

A Phase 3 study testing DisCoVisc, DuoVisc and BioVisc in people with Cataracts, 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

A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery. Read more about this study

Who is it for?: Ages 49 years and older
Conditions the study is for: Cataracts
What is being tested?: DisCoVisc, DuoVisc and BioVisc
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: 1 siteUnited States
Study dates: May 2007to Feb 2008
Phase: Phase 3
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

Unilateral operable cataracts

Who cannot join

Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
Intraocular Pressure (IOP) > 21
History of ocular inflammation
Systemic or ocular diseases affecting corneal endothelium

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

Conditions: Cataracts
Being tested: DisCoVisc, DuoVisc, BioVisc, Healon5, Amvisc Plus
Keywords: DisCoVisc OVD, Ophthalmic Viscosurgical Device
Medical subject headings: Cataract

What participants receive

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

DisCoViscDevice
DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
DuoViscDevice
DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
BioViscDevice
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Healon5Device
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Amvisc PlusDevice
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Study groups in NCT00732225
Study group	Role	What they receive
DisCoVisc	Active comparator	Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) Receives: Device: DisCoVisc
DuoVisc	Active comparator	Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) Receives: Device: DuoVisc
BioVisc	Active comparator	Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) Receives: Device: BioVisc
Healon5	Active comparator	AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) Receives: Device: Healon5
Amvisc Plus	Active comparator	Bausch \& Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) Receives: Device: Amvisc Plus

What is being measured

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

Percent Loss of Endothelial Cells
Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.
Measured: 2 months following surgery

Secondary outcomes (7)

Aqueous Signs - Corneal Edema
Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:
0 - None
1. - Mild, slight localized or generalized edema
2. - Moderate, significant localized or generalized edema
3. - Severe, advanced localized or generalized edema
Measured: 1 day after surgery
Aqueous Signs - Aqueous Flare
Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:
0-None: No visible flare when compared with the normal eye.
1. Mild: Flare visible against dark papillary background but not visible against iris background.
2. Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.
3. Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.
Measured: 1 day following surgery
Aqueous Signs - Aqueous Cells
Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:
0 - None
1. - 1 to 5 cells
2. - 6 to 15 cells
3. - 16 to 30 cells
4. - >30 cells
Measured: 1 day following surgery
Intraocular Pressure (IOP)
Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.
Measured: 1 day following surgery
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.
Measured: Time of Surgery
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification
Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance
Measured: Time of Surgery
Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion
Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance
Measured: Time of Surgery

Timeline

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

May 2007Feb 2008

First posted11 Aug 2008 (estimated)
Study startMay 2007
Primary completionFeb 2008

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 CataractsStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00732225
Sponsor's protocol ID: M07-015
Status last verified: Jun 2010
First submitted: 7 Aug 2008
Last updated: 30 Jul 2010
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 Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery
ClinicalTrials.gov ID: NCT00732225
Acronym / sponsor ID: M07-015
Conditions: Cataracts
Keywords: DisCoVisc OVD, Ophthalmic Viscosurgical Device
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Feb 2008 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 30 Jul 2010

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
DisCoVisc	Active comparator	Device: DisCoViscAlcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoVisc	Active comparator	Device: DuoViscAlcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioVisc	Active comparator	Device: BioViscSophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5	Active comparator	Device: Healon5AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
Amvisc Plus	Active comparator	Device: Amvisc PlusBausch \& Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Who may qualify

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

Key inclusion criteria (1 listed)

Unilateral operable cataracts

Key exclusion criteria (4 listed)

Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
Intraocular Pressure (IOP) > 21
History of ocular inflammation
Systemic or ocular diseases affecting corneal endothelium

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
DisCoViscDisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.	Device	DisCoVisc
DuoViscDuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.	Device	DuoVisc
BioViscBioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.	Device	BioVisc
Healon5Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.	Device	Healon5
Amvisc PlusAmvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.	Device	Amvisc Plus

Primary outcome

Percent Loss of Endothelial Cells
Time frame: 2 months following surgery
Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.

7 secondary outcomes

Aqueous Signs - Corneal Edema
Time frame: 1 day after surgery
Aqueous Signs - Aqueous Flare
Time frame: 1 day following surgery
Aqueous Signs - Aqueous Cells
Time frame: 1 day following surgery
Intraocular Pressure (IOP)
Time frame: 1 day following surgery
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Time frame: Time of Surgery
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification
Time frame: Time of Surgery
Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion
Time frame: Time of Surgery

Results and safety

Results posted to the registry on 30 Jul 2010, 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	71	60
DuoVisc	40	32
BioVisc	26	23
Healon5	33	29
AmviscPlus	54	48

Primary outcome: Percent Loss of Endothelial Cells

Time frame: 2 months following surgery. Mean (Standard Deviation). Unit: Percent Loss

Measure	DisCoVisc n = 64	DuoVisc n = 32	BioVisc n = 23	Healon5 n = 29	AmviscPlus n = 46
Value	9.48 (20.72)	15.66 (11.03)	23.69 (13.47)	25.70 (13.94)	23.04 (16.20)

Population analysed: This data was collected on the eyes of patients attending the visit 2 months after surgery.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DisCoVisc	0 of 76 (0%)	0 of 76 (0%)	Not reported
DuoVisc	0 of 41 (0%)	0 of 41 (0%)	Not reported
BioVisc	0 of 26 (0%)	0 of 26 (0%)	Not reported
Healon5	0 of 33 (0%)	0 of 33 (0%)	Not reported
AmviscPlus	0 of 55 (0%)	0 of 55 (0%)	Not reported

Limitations and caveats (from the sponsor): At the time of surgery, patients were assigned to a study group based on the availability of study Ophthalmic Viscosurgical Devices (OVDs).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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RecruitingObservational study
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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 3 study testing DisCoVisc, DuoVisc and BioVisc in people with Cataracts, 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 1 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 30 Jul 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Jul 2010). 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?

Percent Loss of Endothelial Cells (time frame: 2 months following surgery). 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 NCT00732225.

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 30 Jul 2010.