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Which is Better? Combined or Sequential approach of Cataract Surgery and Bevacizumab for patients with both Cataract and Diabetic Macular Edema problem

Comparative Study on the effectiveness of Combined Cataract Surgery with Intravitreal Bevacizumab Versus Sequential Intravitreal Bevacizumab Followed by Cataract Surgery in Diabetic Macular Edema. - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078209
Enrollment
27
Registered
2024-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa Health Condition 2: H36- Retinal disorders in diseases classified elsewhere

Interventions

Control Intervention1: Intravitreal Injection Bevacizumab: Drug : Bevacizumab(Anti VEGF)
Dose : 1.25 mg in 0.05 ml
Frequency: 1 injection
Follow op period: 6 months
Method : Patients with both Cataract and Diabetic Macular Edema selected, divided into 2 groups, one group (interventional arm) will undergo cataract surgery along with Intravitreal Bevacizumab in sin

Sponsors

DEPARTMENT OF OPHTHALMOLOGY REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic patients with immature cataract with varying levels of diabetic Retinopathy with Diabetic macular edema with or without treated with Pan Retinal Photocoagulation in the past Visual Acuity less than (6/18)

Exclusion criteria

Exclusion criteria: Catarct due to other causes such as traumatic , developmental, complicated cataract Advanced Diabetic Eye Disease , Vitreous Haemorrhage, Tractional membranes, History of ocular trauma Prior or concomitant surgery such as vitreoretinal surgery , glaucoma surgery in the operated eye, intraoperative complications. History of Uveitis, Presence of any retinal or choroidal disease(such as Retinal Vein Occlusion, Ocular Ischemic Syndrome, and Age related Macular Degeneration) , systemic conditions other than diabetes, that could affect retinal thickness .

Design outcomes

Primary

MeasureTime frame
Changes in Macula using SD – OCT both Qualitative (central macular thickness ) and Quantitatively.Timepoint: within 1 week preoperative period,post operatively 14 days, 1 month, 3 month and 6 month.

Secondary

MeasureTime frame
Visual Acuity using Snellens chart.Timepoint: 1 day, 7 days, 14 days, 30 days, then monthly for 6 months after surgery.

Countries

India

Contacts

Public ContactDr CHITRA N

REGIONAL INSTITUTE OF OPHTHALMOLOGY and GOVERNMENT OPHTHALMIC HOSPITAL

drrskalai@gmail.com9840365372

Outcome results

None listed

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