Cataract SurgeryPhase 4NCT00407017
Therapeutic Variables in Cataract Surgery
A Phase 4 study testing Gatifloxacin, Ketorolac LS and Pred Forte in people with Cataract Surgery, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Gatifloxacin, Ketorolac LS and Pred Forte
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Males or females scheduled to undergo cataract surgery
- Patients can be receiving monofocal IOLs only
- Likely to complete all study visits and able to provide informed consent
- Visual potential of 20/25 or better
Who cannot join
- 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
The Center for Excellence in Eye Care
Miami, Florida, 33176
About this study
The purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits.
- Conditions
- Cataract Surgery
- Being tested
- Gatifloxacin, Ketorolac LS, Pred Forte, Moxifloxacin, Nepafenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GatifloxacinDrug
Ketorolac LSDrug
Pred ForteDrug
MoxifloxacinDrug
NepafenacDrug
EconoPred PlusDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Trattler, MD, Principal investigator, The Center For Excellence in Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407017
- Sponsor's protocol ID
- 5264-T
- Status last verified
- Aug 2007
- First submitted
- 30 Nov 2006
- Last updated
- 21 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Variables in Cataract Surgery
- ClinicalTrials.gov ID
- NCT00407017
- Acronym / sponsor ID
- 5264-T
- Conditions
- Cataract Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- First posted
- 4 Dec 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.
The purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females scheduled to undergo cataract surgery
- Patients can be receiving monofocal IOLs only
- Likely to complete all study visits and able to provide informed consent
- Visual potential of 20/25 or better
Key exclusion criteria (3 listed)
- Known contraindications to any study medication or ingredients
- Active ocular diseases or uncontrolled systemic disease
- Active ocular allergies
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 |
|---|---|---|
| Gatifloxacin | Drug | – |
| Ketorolac LS | Drug | – |
| Pred Forte | Drug | – |
| Moxifloxacin | Drug | – |
| Nepafenac | Drug | – |
| EconoPred Plus | 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 21 Aug 2007.
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Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
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Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
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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.
William Trattler, MD principal investigator
The Center For Excellence in Eye Care
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 Gatifloxacin, Ketorolac LS and Pred Forte in people with Cataract Surgery, 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 3 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 21 Aug 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 21 Aug 2007.