Diffuse diabetic macular edema
Conditions
Interventions
patterned laser phototherapy
Sponsors
Nagoya City University Gradate School of Medical Sciences
St. Luke'
s international hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography. Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point <10% and signal strength of 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible. The distance visual acuity in the better eye corrected the study must have an index between 0.3 and 1.0 LogMAR visual acuity inclusive (Snellen equivalent of 20/40 to 20/200). Clear media and eye pupil dilation adequate to allow fundus photography with good quality. Intraocular pressure not exceeding 21 mmHg. The ophthalmologist should feel comfortable with the delay of the focal laser treatment (direct and grid, as needed) by at least 12 weeks in the study eye. Patients with diabetes Type 1 or Type 2 as defined by WHO criteria of any gender and age 20 years. Ability to provide a written consent. Ability to return for all study visits.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected visual logMAR acuity (BCVA) Central macular thickness by OCT Retinal sensitivity measured by microperimetry | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of leakage areas on FA. | — |
Countries
Japan
Contacts
Public ContactMiho Nozaki
Nagoya City University Gradate School of Medical Sciences Department of Ophthalmology and Visual Science
Outcome results
None listed