CataractsPhase 4NCT01298973
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
A Phase 4 study testing Viscoat and Saline in people with Cataracts, run by Innovative Medical at 2 sites in United States.
Trial summary
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Viscoat and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Jan 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent, complete questionnaires, and likely to complete all visits
- Subject must be male or female, of any race, and at least 21 years old
- Undergoing uncomplicated cataract surgery with clear corneal incisions
Who cannot join
- Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
- Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
- Uncontrolled systemic disease
- Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
- Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment
- Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
- Concurrent participation or participation in the last 30 days in any other clinical trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida Eye Microsurgical Institute
Boynton Beach, Florida
Eye Physicians of Central Florida
Maitland, Florida
About this study
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
- Conditions
- Cataracts
- Being tested
- Viscoat, Saline
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViscoatDrug
One group will receive Viscoat for incision closure
SalineDrug
One group will receive Saline to irrigate the wound
| Study group | Role | What they receive |
|---|---|---|
| Saline | Experimental | One group will receive Saline to irrigate the wound Receives: Drug: Saline |
| Viscoat | Experimental | One group will receive Viscoat to close the surgical wound Receives: Drug: Viscoat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ensure watertight, patient wound closure after clear corneal cataract incisions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298973
- Sponsor's protocol ID
- Alcon2011-VIS-001
- Status last verified
- Jan 2012
- First submitted
- 28 Jan 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
- ClinicalTrials.gov ID
- NCT01298973
- Acronym / sponsor ID
- Alcon2011-VIS-001
- Conditions
- Cataracts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Feb 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.
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Experimental | Drug: SalineOne group will receive Saline to irrigate the wound |
| Viscoat | Experimental | Drug: ViscoatOne group will receive Viscoat to close the surgical wound |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide informed consent, complete questionnaires, and likely to complete all visits
- Subject must be male or female, of any race, and at least 21 years old
- Undergoing uncomplicated cataract surgery with clear corneal incisions
Key exclusion criteria (7 listed)
- Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
- Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
- Uncontrolled systemic disease
- Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
- Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment
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 |
|---|---|---|
| ViscoatOne group will receive Viscoat for incision closure | Drug | Viscoat |
| SalineOne group will receive Saline to irrigate the wound | Drug | Saline |
Primary outcome
Ensure watertight, patient wound closure after clear corneal cataract incisions
Time frame: 1 year
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 18 Jan 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Viscoat and Saline in people with Cataracts, run by Innovative Medical at 2 sites 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 3 inclusion and 7 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 18 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 2 sites 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?
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?
Ensure watertight, patient wound closure after clear corneal cataract incisions (time frame: 1 year). 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 18 Jan 2012.