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To study the efficacy of Additional posterior barrage laser in Type 1 Zone 2 ROP

Additional posterior barrage compared to standard laser treatment in Type I Zone 2 ROP: An open label randomized trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013779
Enrollment
80
Registered
2018-05-09
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: null- Preterm babies with Type I Zone 2 ROP

Interventions

Intervention1: Additional Posterior barrage laser in the study eye compared to standard laser treatment in the control eye: Additional posterior barrage lase in the study eye was done in one sitting.

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age 2. Birth weight 3. GA 34-36 wks/ BW 1750-2000g in VLBW babies 4. Bilateral Symmetrical Type I Zone 2 ROP

Exclusion criteria

Exclusion criteria: 1. Advanced ROP- Stage 4/5 2. Beyond Type II ROP 3. Zone 1 4. Zone 3 5. Hazy media 6. Systemically unstable babies

Design outcomes

Primary

MeasureTime frame
To note the early regression with the additional posterior barrage laser along with the standard laser treatmentTimepoint: The child is followed post laser treatmnt at 1 week, 2 weeks, 4 weeks,8 weeks and 12 weeks. The regression of the ridge is noted at each visit.

Secondary

MeasureTime frame
To compare the regression of the plus status, clock hours, TVL, laser episodes, refractionTimepoint: The child is followed up at 1 week, 2 weeks, 4 weeks , 8 weeks and 12 weeks to note the plus status, clock hours of regression, TVL. Refraction is done at the end of 12 weeks to note the change in the refractive error secondary to laser procedure.

Countries

India

Contacts

Public ContactDr R Harika

AIIMS

parijatchandra@gmail.com01126593019

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026