Macular EdemaNCT01694212
Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
A study testing Perioperative Diclofenac eye-drops administration in people with Macular Edema and Cataract, run by Eye Clinic Medic Zuljan Jukic at 1 site in Croatia.
Trial summary
Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Macular Edema, Cataract, Diabetic Retinopathy
- What is being tested?
- Perioperative Diclofenac eye-drops administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2012to Dec 2016
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of nonproliferative diabetic retinopathy
- presence of the cataract (LOCS 2-3)
Who cannot join
- other chronic or acute eye diseases
- hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
- allergy to salycilates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.
- Conditions
- Macular Edema, Cataract, Diabetic Retinopathy
- Being tested
- Perioperative Diclofenac eye-drops administration, placebo
- Keywords
- Macular edema, Cataract, Diabetic retinopathy, Anti-inflammatory agents,Non-steroidal
- Medical subject headings
- Macular Edema, Cataract, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Diclofenac eye-drops administrationDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Experimental | Patients with diabetic retinopathy having preoperative treatment with diclofenac Receives: Drug: Perioperative Diclofenac eye-drops administration |
| Placebo | Placebo comparator | Control group having placebo treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Central Macular Thickness
The central macular thickness will be measured with OCT machine.
Measured: -7, 0, 1, 7, 30, 90 days after the cataract surger
Secondary outcomes (2)
progression of diabetic retinopathy
The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria
Measured: -7 and 90 days after cataract surgery
IL-12 concentration
The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
Measured: immediately before cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Clinic Medic Zuljan Jukic
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Center, Split, University of Zagreb
- Responsible party
- Principal investigator, Ljubo Znaor, Clinical Hospital Center, Split
- Investigators
- Ljubo Znaor, MD PhD, Principal investigator, Clinical Hospital Center, Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694212
- Sponsor's protocol ID
- MZJ-2106
- Status last verified
- Apr 2017
- First submitted
- 23 Sep 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01694212
- Acronym / sponsor ID
- MZJ-2106
- Conditions
- Macular Edema, Cataract, Diabetic Retinopathy
- Keywords
- Macular edema, Cataract, Diabetic retinopathy, Anti-inflammatory agents,Non-steroidal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Eye Clinic Medic Zuljan JukicUniversity, hospital or other
- Collaborators
- Clinical Hospital Center, Split, University of Zagreb
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Sep 2012 (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.
Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Experimental | Drug: Perioperative Diclofenac eye-drops administrationPatients with diabetic retinopathy having preoperative treatment with diclofenac |
| Placebo | Placebo comparator | Drug: placeboControl group having placebo treatment |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of nonproliferative diabetic retinopathy
- presence of the cataract (LOCS 2-3)
Key exclusion criteria (3 listed)
- other chronic or acute eye diseases
- hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
- allergy to salycilates
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 |
|---|---|---|
| Perioperative Diclofenac eye-drops administration | Drug | Diclofenac |
| placebo | Drug | Placebo |
Primary outcome
Change of Central Macular Thickness
Time frame: -7, 0, 1, 7, 30, 90 days after the cataract surger
The central macular thickness will be measured with OCT machine.
2 secondary outcomes
progression of diabetic retinopathy
Time frame: -7 and 90 days after cataract surgery
IL-12 concentration
Time frame: immediately before cataract surgery
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 20 Apr 2017.
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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.
Ljubo Znaor, MD PhD principal investigator
Clinical Hospital Center, Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Diclofenac eye-drops administration in people with Macular Edema and Cataract, run by Eye Clinic Medic Zuljan Jukic at 1 site in Croatia.
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 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 20 Apr 2017. 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 Croatia. 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. Some participants in this study may receive a placebo. 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?
Change of Central Macular Thickness (time frame: -7, 0, 1, 7, 30, 90 days after the cataract surger). 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 20 Apr 2017.