Status:
COMPLETED
Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
Lead Sponsor:
Hospital Juarez de Mexico
Conditions:
Diabetic Retinopathy
Macular Edema
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief 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 ph...
Detailed Description
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the firs...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00900887
Start Date
April 1 2008
End Date
March 1 2015
Last Update
March 20 2015
Active Locations (1)
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1
Virgilio Lima Gomez
Mexico City, Mexico City, Mexico, 07760