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Tropicamide versus cyclopentolate for cycloplegic refraction in the paediatric population

Efficacy of tropicamide 1% versus cyclopentolate 1% for cycloplegic refraction in the paediatric population of Eastern India: A crossover randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095397
Enrollment
500
Registered
2025-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: H521- Myopia Health Condition 2: H522- Astigmatism Health Condition 3: H520- Hypermetropia

Interventions

Intervention1: Cyclopentolate: 1% Cyclopentolate eyedrops will be put in both eyes of the patient and mydriasis and cycloplegia done by the drug will be noted. Control Intervention1: Tropicamide: 1% C

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 18 years Children willing to and able to attend three visits and No known allergy to tropicamide or cyclopentolate

Exclusion criteria

Exclusion criteria: 1. Children less than 6 years 2. Children are uncooperative for subjective acceptance 3. History of ocular surgery or trauma 4. Systemic illness requiring regular medication 5. Previous use of atropine or other cycloplegics in the past 3 months 6. Children with strabismus or nystagmus 7. Children with any neurological disorder 8. History of any drug use or ocular or systemic disorder that affects accommodation

Design outcomes

Primary

MeasureTime frame
1.Cycloplegic refractive error with 1% cyclopentolate 2.Cycloplegic refractive error with 1% tropicamide Timepoint: Group A initially receives cycloplegic refraction with 1% Cyclopentolate, followed by subjective acceptance testing after one week. After a washout period of one week, the same group undergoes cycloplegic refraction with 1% Tropicamide, followed again by subjective acceptance testing and vice versa for group B.

Secondary

MeasureTime frame
Subjectively accepted spherical equivalent with 1% cyclopentolate versus 1% tropicamideTimepoint: follow up 1 week later

Countries

India

Contacts

Public ContactShoubhik Chakraborty

KALINGA INSTITUTE OF MEDICAL SCIENCES , BHUBANESWAR

optomshoubik@gamil.com9002059793

Outcome results

None listed

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