Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation

Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation - EYE DMI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042801

Enrollment

900

Registered

2021-01-12

Start date

2021-01-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Ischemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for Part A cross-sectional: Adults =/>18 years (=/>20 years old in Japan) Treated with PRP for DR in previous five years (but not in the six months before patient enrollment)* Inclusion criteria for Part B follow-up: Fifty-four letters or better based on Best Clinic Visual Acuity (using Early Treatment Diabetic Retinopathy Study [ETDRS] chart)* DMI, defined as a foveal avascular zone (FAZ) with =/>0.5mm2 area in superficial capillary plexus, on OCTA (Optovue AngioVue). If FAZ is <0.5mm2, then enlarged peri-foveal inter-capillary space in at least one quadrant will be sufficient*

Exclusion criteria

Exclusion criteria: Exclusion criteria (Part A and B): Patients currently participating in an interventional trial with an ophthalmologic experimental therapy Exclusion criteria (Part B only): Severe DRIL, i.e., affecting 50% or more of the central one-mm-wide zone centered on the fovea (foveal DRIL), as defined by Sun et al. [R19-4048]* Any concurrent macular abnormality other than DMI and DME that, in the opinion of the investigator, would interfere with the assessment of DMI and DME (e.g., significant macular epiretinal membrane, neovascular age-related macular degeneration, and macular hemorrhage)*

Design outcomes

Primary

Measure	Time frame
Best Clinic Visual Acuity Best Clinic Visual Acuity is measured with glasses and with pinhole occluder (if glasses are regularly worn) or unaided and with pinhole occluder (if glasses are not regularly worn) Change in Visual Acuity under normal light condition will be measured by the number of letters read from an ETDRS chart Low-Luminance Best Clinic Visual Acuity Low-Luminance Visual Acuity is the Best Clinic Vision with a mesopic filter added to the ETDRS Cabinet. Change in Visual Acuity under low-luminance condition will be measured by the number of letters read from an ETDRS chart, applying a mesopic filter.	—

Measure

Time frame

Best Clinic Visual Acuity Best Clinic Visual Acuity is measured with glasses and with pinhole occluder (if glasses are regularly worn) or unaided and with pinhole occluder (if glasses are not regularly worn) Change in Visual Acuity under normal light condition will be measured by the number of letters read from an ETDRS chart Low-Luminance Best Clinic Visual Acuity Low-Luminance Visual Acuity is the Best Clinic Vision with a mesopic filter added to the ETDRS Cabinet. Change in Visual Acuity under low-luminance condition will be measured by the number of letters read from an ETDRS chart, applying a mesopic filter.

—

Countries

Japan,Asia(except Japan),North America,Europe

Contacts

Public ContactYasuzumi Shimizu

IQVIA Services Japan, K.K. Real-World Evidence Services, Real-World Analytics Solutions

yasuzumi.shimizu@iqvia.com080-4409-9223

Outcome results