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Early operation of the seeing layer of the eye in complicated diabetic disease of the eye

Early Macular Reconstruction In Proliferative Diabetic Retinopathy

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032492
Enrollment
30
Registered
2021-04-01
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: H353- Degeneration of macula and posterior pole Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Early vitrectomy within 1 month diagnosis: Early vitrectomy within 1 month diagnosis in cases of epiretinal membranes, vitreomacular traction and partial/full thickness macular hole Con

Sponsors

Institute Ethics Commitee AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. PDR eyes 2. Controlled Diabetes Mellitus and Hypertension 3. Visual acuity at least 3/60 or better 4. Phakic clear lenses or pseudophakic eyes 5. Prior laser done at least 3 months back 6. Anti- VEGF given at least 1 month back 7. Informed Consent 8. Older than 18 years of age

Exclusion criteria

Exclusion criteria: 1. Glaucomatous advanced cupping 2. Pale Discs 3. Associated Macular Degeneration 4. No associated retinal vascular occlusions. 5. Prior Retinal surgeries 6. Poor glycemic control, uncontrolled hypertension, overt diabetic nephropathy

Design outcomes

Primary

MeasureTime frame
Improvement of Best Corrected Visual Acuity (BCVA)by two lines in the ETDRS chart Timepoint: Pre operative, Post operative, 1 week, 1 months, 3 months and 6 months

Secondary

MeasureTime frame
1.Anatomical decrease in Central Macular Thickness by Swept Source OCT. 2.Status of outer retinal bands. 3.Functional outcome of the macula determined by microperimetry. 4.Closure of holes Timepoint: Decrease of central macular thickness to at least less than 300 microns at 1 month, 3 months and 6 months

Countries

India

Contacts

Public ContactDebarun Sharma

AIIMS, New Delhi

atul56kumar@yahoo.com

Outcome results

None listed

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