CataractNCT00992355
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
A study testing Tobramycin 0.3% - Dexamethasone 0.1% and Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5% in people with Cataract, run by Veroia General Hospital at 1 site in Greece.
Trial summary
This randomized controlled trial compares two regimens of topical therapy: tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop… Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Cataract
- What is being tested?
- Tobramycin 0.3% - Dexamethasone 0.1% and Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Apr 2009
- Phase
- Interventional
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phacoemulsification (due to cataract)
- Uneventful phacoemulsification surgery
Who cannot join
- Disruption of the anterior lens capsule
- Age-related macular degeneration
- Proliferative diabetic retinopathy
- Glaucoma
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Ophthalmology, Veroia General Hospital
Véroia, 59100
About this study
Official title: Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial
This randomized controlled trial compares two regimens of topical therapy:
- tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
- combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.
Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for
- corneal edema
- conjunctival redness
- anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.
- Conditions
- Cataract
- Being tested
- Tobramycin 0.3% - Dexamethasone 0.1%, Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
- Keywords
- Cataract, Phacoemulsification, Treatment duration
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin 0.3% - Dexamethasone 0.1%Drug
Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%Drug
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin 0.3% - Dexamethasone 0.1% | Active comparator | Not described Receives: Drug: Tobramycin 0.3% - Dexamethasone 0.1% |
| Tobramycin-Dexamethasone plus Ketorolac tromethamine | Active comparator | Not described Receives: Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5% |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veroia General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992355
- Sponsor's protocol ID
- VGH-EYE01
- Status last verified
- Oct 2009
- First submitted
- 8 Oct 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial
- ClinicalTrials.gov ID
- NCT00992355
- Acronym / sponsor ID
- VGH-EYE01
- Conditions
- Cataract
- Keywords
- Cataract, Phacoemulsification, Treatment duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Veroia General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 9 Oct 2009 (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.
This randomized controlled trial compares two regimens of topical therapy:
- tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
- combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.
Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for
- corneal edema
- conjunctival redness
- anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobramycin 0.3% - Dexamethasone 0.1% | Active comparator | Drug: Tobramycin 0.3% - Dexamethasone 0.1% |
| Tobramycin-Dexamethasone plus Ketorolac tromethamine | Active comparator | Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5% |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Phacoemulsification (due to cataract)
- Uneventful phacoemulsification surgery
Key exclusion criteria (4 listed)
- Disruption of the anterior lens capsule
- Age-related macular degeneration
- Proliferative diabetic retinopathy
- Glaucoma
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 |
|---|---|---|
| Tobramycin 0.3% - Dexamethasone 0.1% | Drug | Tobramycin 0.3% - Dexamethasone 0.1% |
| Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5% | Drug | Tobramycin-Dexamethasone plus Ketorolac tromethamine |
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 9 Oct 2009.
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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 study testing Tobramycin 0.3% - Dexamethasone 0.1% and Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5% in people with Cataract, run by Veroia General Hospital at 1 site in Greece.
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 2 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 9 Oct 2009. 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 Greece. 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.
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 9 Oct 2009.