Macula ThickeningPhase 4NCT00433225
Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation
A Phase 4 study testing Prednisolone Acetate, Ketorolac 0.4% and Gatifloxacin 0.3% in people with Macula Thickening, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macula Thickening
- What is being tested?
- Prednisolone Acetate, Ketorolac 0.4% and Gatifloxacin 0.3%
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Males or females > 50 years old
- Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
- Likely to complete all study visits and able to provide informed consent
- Visual potential of 20/25 or better
Who cannot join
- · Prior use of topical ketorolac
- Known contraindications to any study medication or ingredients
- Active ocular diseases or uncontrolled systemic disease
- Active ocular allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
About this study
The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL.
- Conditions
- Macula Thickening
- Being tested
- Prednisolone Acetate, Ketorolac 0.4%, Gatifloxacin 0.3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone AcetateDrug
Ketorolac 0.4%Drug
Gatifloxacin 0.3%Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula ThickeningStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Donnenfeld, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433225
- Sponsor's protocol ID
- 5293
- Status last verified
- Sep 2007
- First submitted
- 7 Feb 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation
- ClinicalTrials.gov ID
- NCT00433225
- Acronym / sponsor ID
- 5293
- Conditions
- Macula Thickening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- First posted
- 9 Feb 2007 (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 was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females > 50 years old
- Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
- Likely to complete all study visits and able to provide informed consent
- Visual potential of 20/25 or better
Key exclusion criteria (4 listed)
- · Prior use of topical ketorolac
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 |
|---|---|---|
| Prednisolone Acetate | Drug | – |
| Ketorolac 0.4% | Drug | – |
| Gatifloxacin 0.3% | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Sep 2007.
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.
Eric Donnenfeld principal investigator
Ophthalmic Consultants of Long Island
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 Prednisolone Acetate, Ketorolac 0.4% and Gatifloxacin 0.3% in people with Macula Thickening, run by Innovative Medical 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 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 10 Sep 2007. 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?
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.
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 10 Sep 2007.