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Using OCT to CO-relate Diabetic eye disease and kidney disease

Effect of Hemoglobin on Diabetic Macular Edema in Patients of Chronic Kidney Disease- An OCT Based Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026783
Enrollment
87
Registered
2020-07-25
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 Nikhil Gopalakrishnan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Type 1 or Type 2 Diabetic Patients aged 18 or more, with coexisting Chronic Kidney Disease due to Diabetes (Diabetic Nephropathy). - Centre involving Diabetic Macular Edema defined as baseline SD-OCT central subfield thickness of 320 microns in men and 305 microns in women.

Exclusion criteria

Exclusion criteria: - Patients with Chronic Kidney Disease due to etiology other than Diabetic Nephropathy - Patients with Macular Edema or any retinal pathology due to causes other than Diabetes. - Patients with significant media opacities hindering accurate OCT assessment.

Design outcomes

Primary

MeasureTime frame
1.To study the effect of Hemoglobin on presence and severity of Diabetic Macular Edema in the setting of Chronic Kidney Disease. 2.To identify OCT biomarkers or patterns in Diabetic Macular Edema, which are specific for patients with Chronic Kidney Disease i.e., Diabetic Nephropathy associated retinal changes. Timepoint: 2 years

Secondary

MeasureTime frame
To assess the role of renal parameters such as Proteinuria (Microalbuminuria), Serum Urea, Serum Creatinine and GFR on presence and severity of Diabetic Macular EdemaTimepoint: 2 years

Countries

India

Contacts

Public ContactDr Sudha Menon

O.E.U. Institute of Ophthalmology

shailaja.s@manipal.edu9686125861

Outcome results

None listed

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