Clinical trial NCT00907114: Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
Official title: Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Proliferative Diabetic Retinopathy
Macular Edema
Keywords: proliferative diabetic retinopathy
macular edema
panphotocoagulation
topic ketorolac
efficacy
treatment
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2009-05-22
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: center subfield mean thickness using Stratus OCT measured in microns
timeFrame: baseline, 24, 48 and 168 hours after treatment
Secondary outcomes:
measure: center point thickness using Stratus OCT, measured in microns
timeFrame: baseline, 24, 48 and 168 hours after treatment
measure: macular volume using Stratus OCT, measured in cubic millimeters
timeFrame: baseline, 24, 48 and 168 hours after treatment
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Virgilio Lima Gomez
state: Distrito Federal
Study officials:
affiliation: Hospital Juarez de Mexico
name: Virgilio Lima Gomez, MD, MSc
role: STUDY_CHAIR
affiliation: Hospital Juarez de Mexico
name: Dulce M Razo Blanco Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Juarez de Mexico
name: Juan Asbun Bojalil, MD, PhD
role: STUDY_DIRECTOR
References: