Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
- Conditions
- Diabetic RetinopathyMacular Edema
- Interventions
- Registration Number
- NCT00900887
- Lead Sponsor
- Hospital Juarez de Mexico
- 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 photocoagulation in diabetics with clinically significant macular edema.
- 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 first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nepafenac Nepafenac ocular topic nepafenac 3 times a day during one week after selective photocoagulation Polietilenglicol 400, propilenglicol Polietilenglicol 400, propilenglicol ocular lubricant drops 3 times a day for a week after selective photocoagulation Ketorolac Ketorolac ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation
- Primary Outcome Measures
Name Time Method ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation one week after treatment
- Secondary Outcome Measures
Name Time Method visual capacity under subjective refractive correction measured in decimal equivalent before treatment, at 24, 48, 168 hours after treatment center point thickness using stratus OCT measured in microns before treatment, at 24, 48 and 168 hours after treatment macular volume using stratus OCT measured in cubic millimeters before treatment, 24, 48 and 168 hours after treatment
Trial Locations
- Locations (1)
Virgilio Lima Gomez
🇲🇽Mexico, Distrito Federal, Mexico