Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2015-03-31

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.

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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.

Conditions

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Proliferative Diabetic Retinopathy Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ketorolac tromethamine

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

Group Type ACTIVE_COMPARATOR

Ketorolac tromethamine

Intervention Type DRUG

Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation

Polivynilic alcohol

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

Group Type PLACEBO_COMPARATOR

Polivynilic alcohol

Intervention Type DRUG

Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation

Interventions

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Ketorolac tromethamine

Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation

Intervention Type DRUG

Polivynilic alcohol

Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation

Intervention Type DRUG

Other Intervention Names

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Godek Acuafil

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No