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Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Clinical Hospital Center, Split
University of Zagreb
Information provided by (Responsible Party):
Ljubo Znaor, Clinical Hospital Center, Split
ClinicalTrials.gov Identifier:
NCT01694212
First received: September 23, 2012
Last updated: September 26, 2012
Last verified: September 2012

September 23, 2012
September 26, 2012
October 2012
May 2013   (final data collection date for primary outcome measure)
Change of Central Macular Thickness [ Time Frame: -7, 0, 1, 7, 30, 90 days after the cataract surger ] [ Designated as safety issue: No ]
The central macular thickness will be measured with OCT machine.
Same as current
Complete list of historical versions of study NCT01694212 on ClinicalTrials.gov Archive Site
  • progression of diabetic retinopathy [ Time Frame: -7 and 90 days after cataract surgery ] [ Designated as safety issue: No ]
    The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria
  • IL-12 concentration [ Time Frame: immediately before cataract surgery ] [ Designated as safety issue: No ]
    The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
Same as current
Not Provided
Not Provided
 
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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Macular Edema
  • Cataract
  • Diabetic Retinopathy
  • Drug: Perioperative Diclofenac eye-drops administration
  • Drug: placebo
  • Experimental: Diclofenac
    Patients with diabetic retinopathy having preoperative treatment with diclofenac
    Intervention: Drug: Perioperative Diclofenac eye-drops administration
  • Placebo Comparator: Placebo
    Control group having placebo treatment
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
September 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
60 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT01694212
MZJ-2106
No
Ljubo Znaor, Clinical Hospital Center, Split
Eye Clinic Medic Zuljan Jukic
  • Clinical Hospital Center, Split
  • University of Zagreb
Principal Investigator: Ljubo Znaor, MD PhD Clinical Hospital Center, Split
Eye Clinic Medic Zuljan Jukic
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP