JPRN-UMIN000012401
Completed
未知
Assessment of safety and initial therapeutic efficacy of non-damaging patterned scanning laser phototherapy in patients with diffuse diabetic macular edema - safety and efficacy of patterned scanning laser phototherapy in patients with diffuse diabetic macular edema
agoya City University Gradate School of Medical Sciences0 sites10 target enrollmentDecember 2, 2013
ConditionsDiffuse diabetic macular edema
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diffuse diabetic macular edema
- Sponsor
- agoya City University Gradate School of Medical Sciences
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months. Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and / or significant opacification, or the presence of chorioretinal atrophy involving the center of the macula. Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema and prevents the improvement with treatment. Any cause of macular edema other than DME. Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ. Patients who received panphotocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12 weeks or more of treatment with focal or grid laser. Significant opacities of the optical medium, including cataracts, which may interfere with visual acuity, assessment of toxicity or photography background. Patients will not be included if they have high probability of requiring cataract surgery within the next year. Any intraocular surgery within 6 months prior to study entry. Prior peeling of ERM or ILM. Any major surgical procedure within one month of study entry Prior irradiation of the head region of the eye under study. Any previous pharmacological treatment for DME or at any time during the last 90 days for any other condition. Important known allergies to sodium fluorescein dye used in angiography. Acute ocular or periocular infection.
Outcomes
Primary Outcomes
Not specified
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