Diabetic Retinopathy, Macular Edema
Conditions
Keywords
diabetic retinopathy, clinically significant macular edema, selective photocoagulation, topic ketorolac, topic nepafenac, efficacy, treatment
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.
Interventions
DRUGKetorolac
ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
DRUGNepafenac
topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
DRUGPolietilenglicol 400, propilenglicol
ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week
Sponsors
Hospital Juarez de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| visual capacity under subjective refractive correction measured in decimal equivalent | before treatment, at 24, 48, 168 hours after treatment |
Countries
Mexico
Outcome results
None listed