Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Juarez de Mexico
• Treatments: Anti-Inflammatory Agents; Ketorolac; Ketorolac Tromethamine; Nepafenac

Criteria

Inclusion Criteria:

• type 2 diabetes

• regardless of diabetes duration and retinopathy severity level

• one or both eyes with focal clinically significant macular edema

• treated with selective or focal photocoagulation

• visual capacity under subjective refraction before treatment

• adequate quality 6mm fast macular map on the day of photocoagulation

• signed of inform consent

Exclusion Criteria:

• ocular surgery in the last 4 months

• previous selective photocoagulation

• topic or systemic antiinflammatory therapy in the last week

• allergic to antiinflammatory non-steroids therapy

• lent contact used in tha last 2 days before photocoagulation

• history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months

• history of uveitis or ocular inflammation in the last 12 months

• any ocular external disease, infection or inflammatory process during evaluation

• corneal abnormalities that could modify visual capacity per se

• actual corneal disease

• pregnancy

• myopia over -6.00 diopters

• any retinal disease different from diabetic retinopathy

• adverse event of the drug

• desert to pharmacology therapy after the second visit

• no assistance after the second visit

• inadequate quality 6mm fast macular map after the second visit