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Study comparing safety of two drug regimens for dilatation of eyes before retinopathy of prematurity screening in preterm neonates: A double blinded Randomized Controlled Trial

Comparing safety of two drug regimens for pupillary dilatation for retinopathy of prematurity screening in preterm neonates: A double blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039339
Enrollment
230
Registered
2022-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Instillation of mydriatic drops for dilatation before retinopathy of prematurity screening: Instillation of a 3-step combination of 0.5% tropicamide plus 0.5% tropicamide followed by 2.

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age at birth is less than 34 weeks or birth weight

Exclusion criteria

Exclusion criteria: 1. Major malformation 2. Hemodynamic instability 3. Suspicion of cardiovascular disease 4. Anatomical variations of the anterior segment 5. Consent denied by the parents/ attendants

Design outcomes

Primary

MeasureTime frame
a 3-step combination of 0.5% tropicamide plus 0.5% tropicamide followed by 2.5% phenylephrine+0.5% tropicamide vs. a combination of 2.5% phenylephrine+0.5% tropicamide used thrice will cause 50% less increase in diastolic blood pressureTimepoint: 15 minutes after the retinopathy of prematurity screening procedure—

Secondary

MeasureTime frame
To compare the mydriatic efficacy and suitability of pupillary dilatation by assessing the need for rescue dose of the two mydriatic regimens being compared.Timepoint: Before ROP screening (after instillation of mydriatic drops) to 24 hrs after—

Countries

India

Contacts

Public ContactGitanjali Jain

AIIMS, New Delhi

ankitvmmc@yahoo.co.in9868979309

Outcome results

None listed

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