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Role of small amount of retinal laser after injection treatment in premature babies with severe retinal disease

Role of Zone 2 Posterior Sparing Laser Following Intravitreal Ranibizumab Injection in Zone 1 AROP: An Open-label Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079427
Enrollment
50
Registered
2025-01-24
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: H351- Retinopathy of prematurity

Interventions

Intervention1: Intravitreal injection and Zone 2 sparing laser: Zone 2 sparing laser at one week following intravitreal Ranibizumab injection in Zone 1 AROP Control Intervention1: Intravitreal injecti

Sponsors

Janani Shishu Suraksha Karyakram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants with Zone 1 aggressive ROP 2. Stage zero to stage 3 3. Clinically stable and cleared from pediatric high dependency unit for intravitreal injection and laser

Exclusion criteria

Exclusion criteria: 1. Zone 2 ROP disease 2. Stage 4 or stage 5 disease 3. Presence of vitreous hemorrhage 4. Corneal or lenticular opacities 5. Parents not willing or giving consent

Design outcomes

Primary

MeasureTime frame
Proportion of eyes developing reactivation of disease with or without additional zone 2 posterior sparing laser following intravitreal ranibizumab injection in zone 1 AROPTimepoint: 6 weeks post injection—

Secondary

MeasureTime frame
Proportion of eyes developing reactivation of disease with or without additional zone 2 posterior sparing laser following intravitreal ranibizumab injectionTimepoint: At 16 weeks following injection;Anatomical outcome with or without additional zone 2 posterior sparing laser following intravitreal ranibizumab injectionTimepoint: At 16 weeks following injection;Refractive error with or without additional zone 2 posterior sparing laser following intravitreal ranibizumab injectionTimepoint: At 16 weeks following injection—

Countries

India

Contacts

Public ContactDevesh Kumawat

Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi

deveshkumawat21@gmial.com9711797688

Outcome results

None listed

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