Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Detailed Description
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Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation. Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.

Official Title
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Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy

Conditions
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Proliferative Diabetic Retinopathy, Macular Edema

Intervention / Treatment
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* Drug: Ketorolac tromethamine
* Drug: Polivynilic alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes proliferative diabetic retinopathy without macular edema adequate quality 6 mm fast macular map on the day of treatment visual capacity under subjective refraction before treatment signed of inform consent Exclusion Criteria: ocular surgery in the last 4 months myopia over -6.00 diopters allergy to ketorolac or non-steroids antiinflammatory previous selective photocoagulation using non-steroids antiinflammatory or immunomodulators intraocular inflammatory any retinal disease different from diabetic retinopathy pregnancy actual corneal disease inadequate quality 6 mm fast macular map after the second visit inconsistency after the second visit adverse event of the drug remove of the inform consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac tromethamine<br>ocular topic ketorolac used 4 times a day during a week after panphotocoagulation | Drug: Ketorolac tromethamine<br>* Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation<br>* Other names: Godek;|
| Placebo Comparator: Polivynilic alcohol<br>ocular lubricant drops 4 times a day during one week after panphotocoagulation | Drug: Polivynilic alcohol<br>* Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation<br>* Other names: Acuafil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| center subfield mean thickness using Stratus OCT measured in microns |  | baseline, 24, 48 and 168 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| center point thickness using Stratus OCT, measured in microns |  | baseline, 24, 48 and 168 hours after treatment | 
| macular volume using Stratus OCT, measured in cubic millimeters |  | baseline, 24, 48 and 168 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proliferative diabetic retinopathy, macular edema, panphotocoagulation, topic ketorolac, efficacy, treatment