Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Hospital Center, Split | OTHER |
| University of Zagreb | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac | Experimental | Patients with diabetic retinopathy having preoperative treatment with diclofenac |
|
| Placebo | Placebo Comparator | Control group having placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative Diclofenac eye-drops administration | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Central Macular Thickness | The central macular thickness will be measured with OCT machine. | -7, 0, 1, 7, 30, 90 days after the cataract surger |
| Measure | Description | Time Frame |
|---|---|---|
| progression of diabetic retinopathy | The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria | -7 and 90 days after cataract surgery |
| IL-12 concentration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ljubo Znaor, MD PhD | Clinical Hospital Center, Split | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poliklinika Medic Zuljan Jukić | Split | 21000 | Croatia |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
| immediately before cataract surgery |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D002386 | Cataract |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided