CataractNCT01103401
Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
A study testing Drug: Tobramycin 0.3% - Dexamethasone 0.1% and Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine in people with Cataract, run by Veroia General Hospital.
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?
- Drug: Tobramycin 0.3% - Dexamethasone 0.1% and Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2010
- 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
- history of intraocular surgery in the operated eye,
- any previous episode of uveitis in the operated eye,
- severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
- regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
- disruption of the anterior lens capsule
About this study
Official title: Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
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.
Read more
Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for
- corneal edema
- conjunctival hyperemia
- anterior chamber (Tyndall) reaction.
The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.
Read the detailed description
Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.
- Conditions
- Cataract
- Being tested
- Drug: Tobramycin 0.3% - Dexamethasone 0.1%, Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Tobramycin 0.3% - Dexamethasone 0.1%Drug
Also called Tobradex
one drop four times per day
Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamineDrug
Also called Acular
Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin/Dexamethasone | Active comparator | Not described Receives: Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%; Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine |
| Tobramycin/Dexamethasone plus Ketorolac tromethamine | Active comparator | Not described Receives: Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%; Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity, corneal edema, Tyndall reaction, redness
Measured: 1,7,14,28 post-operative day, Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veroia General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Leonidas E Papazisis, Director, Study director, leopapazisis@yahoo.gr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103401
- Sponsor's protocol ID
- VGH-EYE02
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
- ClinicalTrials.gov ID
- NCT01103401
- Acronym / sponsor ID
- VGH-EYE02
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Veroia General HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Apr 2010 (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.
Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for
- corneal edema
- conjunctival hyperemia
- anterior chamber (Tyndall) reaction.
The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.
Detailed description
Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobramycin/Dexamethasone | Active comparator | Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%, Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine |
| Tobramycin/Dexamethasone plus Ketorolac tromethamine | Active comparator | Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%, Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine |
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 (5 listed)
- history of intraocular surgery in the operated eye,
- any previous episode of uveitis in the operated eye,
- severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
- regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
- disruption of the anterior lens capsule
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 |
|---|---|---|
| Drug: Tobramycin 0.3% - Dexamethasone 0.1%Also: Tobradexone drop four times per day | Drug | Tobramycin/Dexamethasone, Tobramycin/Dexamethasone plus Ketorolac tromethamine |
| Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamineAlso: AcularTobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day | Drug | Tobramycin/Dexamethasone, Tobramycin/Dexamethasone plus Ketorolac tromethamine |
Primary outcome
Visual acuity, corneal edema, Tyndall reaction, redness
Time frame: 1,7,14,28 post-operative day, Up to 28 days
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 15 Apr 2015.
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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.
Leonidas E Papazisis, Director study director
leopapazisis@yahoo.gr
Questions about this trial
What is this clinical trial studying?
A study testing Drug: Tobramycin 0.3% - Dexamethasone 0.1% and Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine in people with Cataract, run by Veroia General Hospital.
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 5 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Visual acuity, corneal edema, Tyndall reaction, redness (time frame: 1,7,14,28 post-operative day, Up to 28 days). 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 15 Apr 2015.