GlaucomaNCT00825864
Diclofenac vs Dexamethasone in Combined Surgery
A study testing diclofenac drops and dexamethasone sodium phosphate 0.1% eye drops in people with Glaucoma and Cataract, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- diclofenac drops and dexamethasone sodium phosphate 0.1% eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2004to Jan 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for combines surgery of trabeculectomy and cataract surgery
Who cannot join
- severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.
- Being tested
- diclofenac drops, dexamethasone sodium phosphate 0.1% eye drops
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac dropsDrug
one drop 4 times a day for 3 months
dexamethasone sodium phosphate 0.1% eye dropsDrug
for first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week
| Study group | Role | What they receive |
|---|---|---|
| 1diclofenac drops treatment | Active comparator | four times a day for 3 months Receives: Drug: diclofenac drops |
| 2dexamethasone drops | Active comparator | Not described Receives: Drug: dexamethasone sodium phosphate 0.1% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Measured: year
Secondary outcomes (1)
the number of antiglaucoma medications
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Hani Levkovitch-Verbin, Principal investigator, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825864
- Sponsor's protocol ID
- SHEBA-03-3123-HLV-CTIL
- Status last verified
- Jan 2009
- First submitted
- 18 Jan 2009
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery
- ClinicalTrials.gov ID
- NCT00825864
- Acronym / sponsor ID
- SHEBA-03-3123-HLV-CTIL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Jan 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.
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1diclofenac drops treatment | Active comparator | Drug: diclofenac dropsfour times a day for 3 months |
| 2dexamethasone drops | Active comparator | Drug: dexamethasone sodium phosphate 0.1% eye drops |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for combines surgery of trabeculectomy and cataract surgery
Key exclusion criteria (1 listed)
- severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis
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 |
|---|---|---|
| diclofenac dropsone drop 4 times a day for 3 months | Drug | 1diclofenac drops treatment |
| dexamethasone sodium phosphate 0.1% eye dropsfor first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week | Drug | 2dexamethasone drops |
Primary outcome
intraocular pressure
Time frame: year
1 secondary outcome
the number of antiglaucoma medications
Time frame: year
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 Jan 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.
Hani Levkovitch-Verbin principal investigator
Tel Aviv University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diclofenac drops and dexamethasone sodium phosphate 0.1% eye drops in people with Glaucoma and Cataract, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 Jan 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 Israel. 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.
What does the primary outcome measure?
intraocular pressure (time frame: year). 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 21 Jan 2009; AzTrials last refreshed its copy on 31 Oct 2026.