CataractPhase 4NCT00348244
Ketorolac vs. Steroid in the Prevention of CME
A Phase 4 study testing Ketorolac, Prednisolone Acetate in people with Cataract, run by Innovative Medical at 1 site in United States.
Trial summary
Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Ketorolac, Prednisolone Acetate
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- · Male or female > 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively
- Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
- Ability to provide informed consent and likely to complete all study visits
Who cannot join
- · Known contraindication to any study medication or any of their components
- Uncontrolled systemic disease
- Required use of ocular medications other than the study medications during the study
- Abnormal pre-operative OCTs if obtainable
- Diabetic patients with a history of macular edema or diabetic retinopathy
- AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.
- Conditions
- Cataract
- Being tested
- Ketorolac, Prednisolone Acetate
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac, Prednisolone AcetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Wittpenn, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348244
- Sponsor's protocol ID
- 5152
- Status last verified
- Jan 2007
- First submitted
- 30 Jun 2006
- Last updated
- 17 Jan 2007
- Results posted
- No
Publications
Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
PubMed 18599019
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
- ClinicalTrials.gov ID
- NCT00348244
- Acronym / sponsor ID
- 5152
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 2006 (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.
Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- · Male or female > 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively
Key exclusion criteria (6 listed)
- · Known contraindication to any study medication or any of their components
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 |
|---|---|---|
| Ketorolac, Prednisolone Acetate | 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 17 Jan 2007.
- Derived from this study: PubMed 18599019Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
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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.
John Wittpenn, MD 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 Ketorolac, Prednisolone Acetate in people with Cataract, 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 3 inclusion and 6 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 17 Jan 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?
On the ClinicalTrials.gov record for NCT00348244, which also lists 1 linked publication.
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 17 Jan 2007.