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To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-fluence | Experimental | Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy |
|
| Full-fluence | Active Comparator | Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-fluence PRP with 532nm green LASER | Device | To administer low-fluence PRP in a single session for PDR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular thickness change | Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT) | Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Presence or absence of adverse events | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of neovessels, change over time | Regression of neovessels observed by fluorescein angiography | Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Salcedo-Villanueva, MD | Asociación para Evitar la Ceguera en México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Para Evitar la Ceguera en México | Mexico City | Mexico City | 04030 | Mexico |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Full-Fluence PRP with 532nm LASER | Device | To administer full-fluence PRP in two sessions for PDR |
|
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