Macular Edema, Proliferative Diabetic Retinopathy
Conditions
Keywords
proliferative diabetic retinopathy, macular edema, panphotocoagulation, topic ketorolac, efficacy, treatment
Brief summary
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
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.
Interventions
DRUGKetorolac tromethamine
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
DRUGPolivynilic alcohol
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
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 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| center subfield mean thickness using Stratus OCT measured in microns | baseline, 24, 48 and 168 hours after treatment |
Secondary
| Measure | 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 |
Countries
Mexico
Outcome results
None listed