Trial | NCT01694212  Report issue

Title

Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy
Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    diclofenac ...

  • Study Participants

    55
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 Started
Oct 31
2012
Primary Completion
Oct 31
2016
Study Completion
Dec 31
2016
Last Update
Apr 20
2017

Drug Perioperative Diclofenac eye-drops administration

Drug placebo

Diclofenac Experimental

Patients with diabetic retinopathy having preoperative treatment with diclofenac

Placebo Placebo Comparator

Control group having placebo treatment

Criteria 

Inclusion Criteria:

presence of nonproliferative diabetic retinopathy
presence of the cataract (LOCS 2-3)

Exclusion Criteria:

other chronic or acute eye diseases
hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
allergy to salycilates
No Results Posted