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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac tromethamine | Active Comparator | ocular topic ketorolac used 4 times a day during a week after panphotocoagulation |
|
| Polivynilic alcohol | Placebo Comparator | ocular lubricant drops 4 times a day during one week after panphotocoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac tromethamine | Drug | Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| center subfield mean thickness using Stratus OCT measured in microns | baseline, 24, 48 and 168 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virgilio Lima Gomez, MD, MSc | Hospital Juarez de Mexico | Study Chair |
| Dulce M Razo Blanco Hernandez, MD | Hospital Juarez de Mexico | Principal Investigator |
| Juan Asbun Bojalil, MD, PhD | Hospital Juarez de Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virgilio Lima Gomez | Mexico City | Mexico City | 07760 | Mexico |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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 |
|
|
| D006571 | Heterocyclic Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |