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A double blind randomized study on the effectiveness of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in dark irided hypermetropic children

A double blind randomized study on the effectiveness of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in dark irided hypermetropic children - effectiveness of cycloplegics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30949
Enrollment
45
Registered
2007-10-08
Start date
2007-12-14
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Eye strenght. Refraction

Interventions

One dose of cyclopentolate 1% followed by one dose tropicamide 1%: interval 5 minutes in one eye, and 2 doses of cyclopentolate 1%, interval 5 minutes, in the other eye
compared to 3 days, in total 5 doses atropine 0.5% in both eyes after an interval of 2 weeks.

Sponsors

Medisch Centrum Haaglanden
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Healthy; not suffering from syndromes or diseases, 3 to 6 years (not attending group three of Dutch primary school system) old very dark irided hypermetropic children, possesing good accommodation, with no glasses prior or who did not wear their hypermetropic glasses since at least 4 weeks and able to fixate with each eye.

Exclusion criteria

Exclusion criteria: All children not possesing the inclusioncriteria (D4a)

Design outcomes

Primary

MeasureTime frame
Primary outcome parameter is the refractive outcome. Differences will be considered statistical significant if p 0.25 D will be considered clinical significant.

Secondary

MeasureTime frame
Secondary outcomes are amount of cycloplegia and time to reach optimal refractive outcome and amount of cycloplegia. Differences will be considered statistical significant if p 0.25 D and a difference in time to optimal refractive outcome and/or maximum cycloplegia of >10 minutes will be considered clinical significant.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)