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Association of vision in patients with diabetic macular edema and patterns seen on an investigation named SD-OCT

Association of SD-OCT Derived Biomarkers With Visual Acuity In Diabetic Macular Edema - A Prospective Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017253
Enrollment
150
Registered
2019-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications

Interventions

None listed

Sponsors

Dr Neenu Mariam George
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 1 or type 2 diabetic patients aged 18 years or more attending the outpatient department of Kasturba Hospital, Manipal, who consent to participate in the study. 2. Centre involving macular edema defined as baseline SD-OCT central subfield thickness of 320 micro meter or more for men and 305 micro meter or more for women.

Exclusion criteria

Exclusion criteria: 1. Patients with significant media opacities like cataract and vitreous haemorrhage. 2. Patients who underwent cataract surgery within the last 3 months. 3. Other non-diabetic retinal diseases ( including uveitis, vitreomacular traction syndrome and macular pucker).

Design outcomes

Primary

MeasureTime frame
Association of SD-OCT derived retinal morphology and visual acuityTimepoint: 1 year and 6 months from February,2019 to August,2020

Secondary

MeasureTime frame
Identification of candidates for subsequent clinical trials evaluating long term disease progressionTimepoint: 1 year and 6 months from February,2019 to August,2020

Countries

India

Contacts

Public ContactDr Sulatha V Bhandary

Department of Ophthalmology, Kasturba Medical College, Manipal, Udupi, Karnataka

bhat_shailu@yahoo.com9686125861

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026