Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Hospital Juarez de Mexico

Status and phase: Completed; Phase 2

Conditions: Macular Edema; Proliferative Diabetic Retinopathy

Treatments: Drug: Ketorolac tromethamine; Drug: Polivynilic alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT00907114

HJM 1667/09.03.24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

Ketorolac tromethamine

Active Comparator group

Description:

ocular topic ketorolac used 4 times a day during a week after panphotocoagulation

Treatment:

Drug: Ketorolac tromethamine

Polivynilic alcohol

Placebo Comparator group

Description:

ocular lubricant drops 4 times a day during one week after panphotocoagulation

Treatment:

Drug: Polivynilic alcohol