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

E

Eye Clinic Medic Zuljan Jukic

Status

Completed

Conditions

Cataract
Macular Edema
Diabetic Retinopathy

Treatments

Drug: placebo
Drug: Perioperative Diclofenac eye-drops administration

Study type

Interventional

Funder types

Other

Identifiers

NCT01694212
MZJ-2106

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

55 participants in 2 patient groups, including a placebo group

Diclofenac
Experimental group
Description:
Patients with diabetic retinopathy having preoperative treatment with diclofenac
Treatment:
Drug: Perioperative Diclofenac eye-drops administration
Placebo
Placebo Comparator group
Description:
Control group having placebo treatment
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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