Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Hospital Juarez de Mexico84 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Retinopathy Macular Edema

Interventions

KetorolacDRUG

ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week

NepafenacDRUG

topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week

Polietilenglicol 400, propilenglicolDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Virgilio Lima Gomez

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation

Time frame: one week after treatment

Secondary Outcomes

center point thickness using stratus OCT measured in microns

Time frame: before treatment, at 24, 48 and 168 hours after treatment

macular volume using stratus OCT measured in cubic millimeters

Time frame: before treatment, 24, 48 and 168 hours after treatment

visual capacity under subjective refractive correction measured in decimal equivalent

Time frame: before treatment, at 24, 48, 168 hours after treatment

Data from ClinicalTrials.gov

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