CataractPhase 4NCT00712244
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
A Phase 4 study testing DisCoVisc, DuoVisc and Healon5 in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, 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 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- DisCoVisc, DuoVisc and Healon5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- operable cataracts in at least one eye
Who cannot join
- Endothelial Cell Count (ECC) ≤1500cells/mm2
- Intraocular Pressure (IOP) > 21mm Hg
- previous ocular inflammation
- systemic or ocular conditions affecting corneal endothelium
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, 76134
About this study
Official title: DisCoVisc Versus Competitor
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.
- Conditions
- Cataract
- Being tested
- DisCoVisc, DuoVisc, Healon5, Amvisc Plus
- Keywords
- Discovisc, 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
Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.
DuoViscDevice
Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.
Healon5Device
Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.
Amvisc PlusDevice
Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| DisCoVisc | Active comparator | Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery. Receives: Device: DisCoVisc |
| DuoVisc | Active comparator | Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery. Receives: Device: DuoVisc |
| Healon5 | Active comparator | Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery. Receives: Device: Healon5 |
| Amvisc Plus | Active comparator | Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery. Receives: Device: Amvisc Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Endothelial Cell Loss
Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.
Measured: 1 month after surgery
Secondary outcomes (8)
Percent Gain in Corneal Thickness.
Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.
Measured: 1 week and month after surgery
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 to 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 teh 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 after 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 - 30 cells, 4 - >30 cells.
Measured: 1 day after 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 is between 10 mmHg and 20 mmHg.
Measured: 1 day after surgery
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Surgeon reporting of Anterior Chamber Dome Maintenance of a subject'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
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification
Surgeon reporting of Anterior Chamber Dome Maintenance of a subject'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
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion
Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2009
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712244
- Sponsor's protocol ID
- M07-014
- Status last verified
- Sep 2010
- First submitted
- 7 Jul 2008
- Last updated
- 14 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DisCoVisc Versus Competitor
- ClinicalTrials.gov ID
- NCT00712244
- Acronym / sponsor ID
- M07-014
- Conditions
- Cataract
- Keywords
- Discovisc, Ophthalmic Viscosurgical Device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 16 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DisCoVisc | Active comparator | Device: DisCoViscUse of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery. |
| DuoVisc | Active comparator | Device: DuoViscUse of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery. |
| Healon5 | Active comparator | Device: Healon5Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery. |
| Amvisc Plus | Active comparator | Device: Amvisc PlusUse of Amvisc Plus ophthalmic viscosurgical device during cataract surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- operable cataracts in at least one eye
Key exclusion criteria (4 listed)
- Endothelial Cell Count (ECC) ≤1500cells/mm2
- Intraocular Pressure (IOP) > 21mm Hg
- previous ocular inflammation
- systemic or ocular conditions 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 |
|---|---|---|
| DisCoViscUse of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery. | Device | DisCoVisc |
| DuoViscUse of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery. | Device | DuoVisc |
| Healon5Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery. | Device | Healon5 |
| Amvisc PlusUse of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery. | Device | Amvisc Plus |
Primary outcome
Corneal Endothelial Cell Loss
Time frame: 1 month after surgery
Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.
8 secondary outcomes
Percent Gain in Corneal Thickness.
Time frame: 1 week and month after surgery
Aqueous Signs - Corneal Edema
Time frame: 1 day after surgery
Aqueous Signs - Aqueous Flare
Time frame: 1 Day after Surgery
Aqueous Signs - Aqueous Cells
Time frame: 1 day after surgery
Intraocular Pressure (IOP)
Time frame: 1 day after surgery
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Time frame: Time of surgery
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification
Time frame: Time of Surgery
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion
Time frame: Time of Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, DuoVisc and Healon5 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 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 14 Sep 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 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 16 Jun 2009). 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?
Corneal Endothelial Cell Loss (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2010.