FindTrial
Sign In

To study the pupil dilating effects between two types eyedrops in preterm babies for Retinopathy of prematurity screening.

Mydriatic Efficacy for ROP screening and safety profile of Tropicamide (0.4%) plus Phenylephrine (2.5%) versus Tropicamide (1%) alone: Prospective randomized comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016148
Enrollment
53
Registered
2018-10-25
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: R001- Bradycardia, unspecified Health Condition 2: R068- Other abnormalities of breathing Health Condition 3: P84- Other problems with newborn Health Condition 4: R000- Tachycardia, unspecified

Interventions

Intervention1: Tropicamide (0.4%) plus Phenylephrine (2.5%) combination eyedrop: 1 dropapplied every 15minutes , totally 3times and then pupil size, heart rate, oxygen saturation , respitatory rate

Sponsors

Dr Camina Andrew
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants in NICU who require ROP screening

Exclusion criteria

Exclusion criteria: Infants with culture positive sepsis in Isolation room

Design outcomes

Primary

MeasureTime frame
To assessing the mydriatic efficacy of Topical Tropicamide(0.4%) plus Phenylephrine(2.5%) versus topical Tropicamide(1%) for screening retinopathy of prematurity at the end of 45minutesTimepoint: 6months—

Secondary

MeasureTime frame
To compare the systemic side effects of Topical Tropicamide(0.4%) plus Phenylephrine(2.5%) versus topical Tropicamide(1%) when used in screening premature babies for Retinopathy of prematurity screeningTimepoint: 1 day- day of examination—

Countries

India

Contacts

Public ContactDrShubashree

St. Johns Medical College Hospital

shubashree.karat@gmail.com9900325184

Outcome results

None listed

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