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OpenTrials
Completed

NCT Number: NCT00907114

Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

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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Key information

Conditions

Proliferative Diabetic Retinopathy Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virgilio Lima Gomez

Mexico City, 07760, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

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

Other names: Godek

Polivynilic alcohol

Drug

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

Other names: Acuafil

Primary outcomes

  1. center subfield mean thickness using Stratus OCT measured in microns

    Time frame: baseline, 24, 48 and 168 hours after treatment

Secondary outcomes

  1. center point thickness using Stratus OCT, measured in microns

    Time frame: baseline, 24, 48 and 168 hours after treatment

  2. macular volume using Stratus OCT, measured in cubic millimeters

    Time frame: baseline, 24, 48 and 168 hours after treatment

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study title

Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 22, 2009
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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