To compare the effectiveness of 1) double dose of cyclopentolate and 2) one dose of cyclopentolate and one dose of tropicamide with 3 days, total 5 doses atropine.To investigate whether one dose of tropicamide combined with cyclopentolate is as…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is the refractive outcome. Differences will be
considered statistical significant if p<0.05. A difference in refractive
outcome of > 0.25 D will be considered clinical significant.
Secondary outcome
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<0.05. A difference in amount of accommodation of >
0.25 D and a difference in time to optimal refractive outcome and/or maximum
cycloplegia of >10 minutes will be considered clinical significant.
Background summary
Rationale: In dark irides eyes short acting cycloplegics such as cyclopentolate
and tropicamide are less effective; in mydriasis but especially in obtaining
optimal accommodation paralysis. Long acting atropine; prescribed for home
application, is recommended but causes prolonged visual impairment and
non-compliance affects reliability of measurements. Considering the
disadvantages of atropine the use of short acting cycloplegics would be
preferable. Scientific literature currently does not provide a satisfactory
protocol and/or answers on effectiveness and reliability of short acting
cycloplegics for refractive examination.
Study objective
To compare the effectiveness of 1) double dose of cyclopentolate and 2) one
dose of cyclopentolate and one dose of tropicamide with 3 days, total 5 doses
atropine.
To investigate whether one dose of tropicamide combined with cyclopentolate is
as effective compared with a double dose of cyclopentolate.
Primary outcome
* Detection of statistical or clinical significant- or no difference in
refractive outcome between both methods compared to atropine and between the
two methods.
Secondairy outcomes
* Detection of statistical or clinical significant- or no difference in
(maximum) cycloplegia between both methods.
* Detection of statistical or clinical significant- or no difference in time to
the refractive outcome and the amount of cycloplegia of both methods.
To identify factors that affect effectiveness in refractive outcome, (maximum)
cycloplegia or time needed for effective refractive outcome and (maximum)
cycloplegia of the two methods
Study design
The study is designed as a prospective, randomized double blind trial
Intervention
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.
Study burden and risks
Risk and burden
Child assessments with cycloplegics are standard in ophthalmology. Serious side
effects due to anticholinergic action in the central nerve system of
cycloplegics are rare. The extra visit and repeated non-contact measurements
provide a small burden. Inconveniences will mainly exists due to extra eye drop
application and additional 12 hours blurred vision.
postbus 432
2501 CK Den Haag
Nederland
postbus 432
2501 CK Den Haag
Nederland
Listed location countries
Age
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
All children not possesing the inclusioncriteria (D4a)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003483-22-NL |
| CCMO | NL18430.098.07 |