Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Phase 2

Completed

• Conditions: Macular Edema; Proliferative Diabetic Retinopathy
• Interventions: Drug: Polivynilic alcohol; Drug: Ketorolac tromethamine

• Registration Number: NCT00907114
• Lead Sponsor: Hospital Juarez de Mexico

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.

Study Timeline

• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Study Start: 2009-06
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polivynilic alcohol	Polivynilic alcohol	ocular lubricant drops 4 times a day during one week after panphotocoagulation
Ketorolac tromethamine	Ketorolac tromethamine	ocular topic ketorolac used 4 times a day during a week after panphotocoagulation

Primary Outcome Measures

Name	Time	Method
center subfield mean thickness using Stratus OCT measured in microns	baseline, 24, 48 and 168 hours after treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Virgilio Lima Gomez; 🇲🇽 Mexico, Distrito Federal, Mexico