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The purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Active Comparator | ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation |
|
| Nepafenac | Active Comparator | ocular topic nepafenac 3 times a day during one week after selective photocoagulation |
|
| Polietilenglicol 400, propilenglicol | Placebo Comparator | ocular lubricant drops 3 times a day for a week after selective photocoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation | one week after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| center point thickness using stratus OCT measured in microns | before treatment, at 24, 48 and 168 hours after treatment | |
| macular volume using stratus OCT measured in cubic millimeters | before treatment, 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 |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| C414203 | nepafenac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Nepafenac | Drug | topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week |
|
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| Polietilenglicol 400, propilenglicol | Drug | ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week |
|
|
| visual capacity under subjective refractive correction measured in decimal equivalent | before treatment, at 24, 48, 168 hours after treatment |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D006571 | Heterocyclic Compounds |