To compare one dose of the short acting tropicamide combined with one dose of the longer acting cyclopentolate (c+t) with a double dose of the longer acting cyclopentolate (c+c). To develop a cycloplegics protocol that garantees optimal refractieve…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters are residual accommodation; e.g. depth of
cycloplegia (survey I) and recuperation time of ciliary paralysis (survey II)
and sphincter paralysis (survey III). Differences will be considered
statistical significant if p<0.05. A difference in residual accommodation of >
0.50 D, a difference in recuperation time of > 2 hours of cycloplegia and
pupillary functions, will be considered clinical significant.
Secondary outcome
Survey I
Secondary outcome parameters are 1) time to maximum cycloplegia, 2) time of
stability of (maximum) cycloplegia and 3) changes in astigmatism. Differences
will be considered statistical significant if p<0.05. A difference in time to
maximum cycloplegia of > 10 minutes, a difference in stability time of > 10
minutes, and a change of > 0.50 D cylinder or a change of >5° in cylindrical
axis will be considered clinical significant.
Background summary
Tropicamide is less effective in inhibiting accommodation and has a small
window of maximum activity. Cyclopentolate is more effective but in darker
pigmented subjects a significant residual accommodation can be present.
Children often show resistance against the adminisatrion of cyclopegic
eyedrops. Sqeezing of eyelids and/or crying with hyperlacrimation provide a
smaller amount of- or diluting of cycloplegics. A smaller amount of
cycloplegic(s) might cause insufficient cycloplegia. Insufficient cycloplegia
interferes, especially in darker pigmented subjects, with refractive outcomes.
Scientific literature currently does not provide an answer on efficacy and
reliability of cycloplegics in the presence of squeezing and/or dilution.
Time might be an important aspect in reliability of outcomes. On a regular base
there is delay during consultation. In tropicamide, the time where in reliable
measurements can be made, especially in darker pigmented individuals or in case
of squeezing or dilution, is not known.
Amount of mydriasis and/or pupillary reaction to light might be predictors of
sufficient cycloplegia. Scientific literature currently does not provide an
answer on this possible relationship.
Cycloplegia interferes with normal daily life. We could not find reports which
investigated this interference, the subjective wellbeing of children after
cycloplegics and the time course of recuperation of ciliary- and sphincter
paralysis.
Study objective
To compare one dose of the short acting tropicamide combined with one dose of
the longer acting cyclopentolate (c+t) with a double dose of the longer acting
cyclopentolate (c+c). To develop a cycloplegics protocol that garantees optimal
refractieve outcomes, incorperates factors such as pigmentation, resistance and
quality of life.
Study design
This investigator initiated study is designed as a prospective, single-centre,
cross sectional, quantitative, randomized double blind trial with repeated
measurements.
The study is divided in three parts. Survey I measures residual accommodation;
e.g. depth of cycloplegia, time to maximum cycloplegia, and stability of
(complete) cycloplegia in time. Survey II measures (monitors) recuperation of
cycloplegia in time and survey III measures (monitors) recuperation of
mydriasis and pupillary motor function in time.
Duration of the study is approximately 6 months; until 137 subjects completed
the measurements of survey I, 141 subjects completed the measurements of survey
II and 141 completed the measurements of survey III.
Intervention
Randomized
* Two doses of cyclopentolate hydrochloride 1%; with an interval of 5
minutes in both eyes
or
* One dose of cyclopentolate hydrochloride 1% followed by one dose
tropicamide 1%; after an interval of 5 minutes,
in both eyes
Study burden and risks
RISKS
There are no additional risk*s present since subjects are already planned for a
routine cycloplegic refractive assessment according to their treatment or
standard departmental follow-up.
BURDEN
Duration of a standard visit is 75 minutes
Duration of a study visit is:
Survey I : 115 minutes; the extra time added to the standard visit will be 40
minutes
Survey II : 85 minutes; the extra time added to the standard visit will be 10
minutes
Survey III : 75 minutes: no extra time
The extra activities e.g. effort needed because of the study are
Survey I : 5 times a non invasive, simple measurement with a duration of 5-10
seconds
: 5 times a non invasive, simple measurements with a duration of 3
minutes
Survey II : 5 times a non invasive, simple measurement with a duration of 5-10
seconds
: 1 time a non invasive, simple measurements with a duration of 3
minutes
: at daytime for 12 to 24 hours, hourly 1 non invasive,
simple measurement with a duration of maximal 2 minutes
Survey III : 5 times a non invasive, simple measurement with a duration of
5-10 seconds
: at daytime for 12 to 24 hours, hourly 1 non invasive,
simple measurement with a duration of maximal 2 minutes
The extra measurements provide a small burden. Measurements normally are
experienced as amusing due to the images displayed in the devices. All
measurements are done by non-contact devices. Main measurements will be
performed 5 times; with and interval of 15 minutes, and will take 3 minutes
each. The five short measurements will be performed between entry and 50
minutes after the first eye-drop and will take 5 second each. Between
measurements the patients will have the opportunity to play. Inconvenience will
mainly consists of the extended time period of the appointment in survey I, and
the prolonged time of short hourly measurements during 12 to 24 hours in survey
II and III.
Postbus 432
2501 CK Den Haag
NL
Postbus 432
2501 CK Den Haag
NL
Listed location countries
Age
Inclusion criteria
Healthy, light to very dark irided, 7 to 13 years old volunteers, visiting group 4 to 8 of the Dutch primary school system. In addition to be included in survey I and II, children should be hypermetropic; whether or not wearing glasses, with normal accommodation, sufficient reading capabilities and a best corrected visual acuity for distance of ><=0.7 and near of ><=1.0. To be included in survey III children should be emmetropic or myopic, have pupils that are equal in size and react normally.
Exclusion criteria
Physical illness, aged <7 and >13 year, attending group 3 of the Dutch school system or attending secondary school. For survey I and II refractive errors < +0.50D with or without glasses, insufficient accommodation, insufficient reading capabilities, best corrected distance visual acuity of < 0.7 and near visual acuity of <1.0. For survey III having hypermetropia, unequal pupil sizes or abnormal pupillary reactions.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021410-34-NL |
| CCMO | NL32954.098.10 |
| OMON | NL-OMON21701 |