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Efficacy and safety of mydriasis in low-dose compound tropicamide eye drops: a non-inferior, randomized controlled study

Efficacy and safety of mydriasis in low-dose compound tropicamide eye drops: a non-inferior, randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102946
Enrollment
Unknown
Registered
2025-05-22
Start date
2024-10-15
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Retinopathy of prematurity

Interventions

Standard dose-Low dose group:One drop of the standard-dose combined topiramide (approximately 30 µL) was screened for the first time, and after a 1 to 2-week washout period, a small dose of combined t
Low dose-Standard dose group:The first screening of low-dose combined topiramide (15 µL), after a 1 to 2-week washout period, a drop of the standard dose of combined topiramide (approximately 30 µL) w

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Preterm infants with gestational age <32 weeks or birth weight <2000g were screened for retinopathy of prematurity during hospitalization.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Pupil diameter;

Secondary

MeasureTime frame
Heart rate;Blood pressure(SBPDBPMBP);Blood oxygen saturation;Intestinal tissue oxygen saturation;Local and systemic adverse events;

Countries

China

Contacts

Public ContactHao Qingfei

The First Affiliated Hospital of Zhengzhou University

zzuhao@163.com+86 371 66862031

Outcome results

None listed

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