Depth of cycloplegia
Conditions
Interventions
Trade Name: cyclopentolaat hydrochloride 1% 10mg/ml
Product Name: cyclopentolate hydrochloride 1%
10 mg/ml
Product Code: RVG 09359
Pharmaceutical Form: Eye drops*
Other descriptive name: cyclopentolate hydrochloride
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
10 mg/ml
Product Name: tropicamide 1%
10 mg/ml
Product Code: RVG 10167
Pharmaceutical Form: Eye drops*
Other descriptive name: tropicamide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1
Sponsors
Medical Centre Haaglanden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is considered for the study when: • Good general health • Age 7 to 13 years o Group 4 - 8 of the Dutch primairy school system Part I and II • Hypermetropia; e.g. > 0. 50 diopters in spherical equivalence (SEQ) values* • Good accommodation; e.q. > 10 diopters with dynamic retinoscopy • Sufficient reading capabilities • Best corrected distance visual acuity (BCDVA) of > 0.7 in each eye • Best corrected near visual acuity (BCNVA) of > 1.0 in each eye Part III • Emmetropia or myopia in SEQ values • Isocoria and normal pupillary responses * SEQ= sphere + cylinder:2 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Not healthy • Aged 13 year • Attending group 3 of the Dutch school system • Attending secondary school Part I and II • Refractive errors < +0.50 • Best corrected visual acuity of < 0.7 in one or both eye’s • Insufficient reading capabilities • Insufficient accommodation Part III • Emmetropia or hypermetropia • An-isocoria or abnormal pupillary responses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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) Primary outcomes •Detection of statistical or clinical significant- or no difference in depth of cycloplegia; e.g. residual accommodation, between c+c and c+t. •Detection of statistical or clinical significant- or no difference in recuperation time of 1) ciliary paralysis and 2) sphincter paralysis between c+c and c+t. ;Secondary Objective: •Detection of statistical or clinical significant- or no difference in time of stability of maximum cycloplegia between c+c and c+t. •Detection of statistical or clinical significant- or no difference in 1) depth of cycloplegia 2)in time to maximum cycloplegia 3) in time of stability of maximum cycloplegia between eye-colour main groups in c+c and c+t. •Identification of factors that affect 1) depth of cycloplegia 2) time of stability of maximum cycloplegia 3) recuperation time from ciliary and sphincter paralysis in c+c and c+t. •Detection of statistical or clinical significant or no differences in changes in astigmatism during the time course of cycloplegia in c+c and c+t. •Establishment of a statistical significant or no relationship between incomplete cycloplegia and changes in astigmatism in c+c and c+t. •Detection of statistical or clinical significant- or no differences in astigmatism between relaxed and demanding accommodation circumstances in c+c and c+t. ;Primary end point(s): Part I Primary outcome parameter is residual accommodation; e.g. depth of cycloplegia. Secondary outcome parameter are time of stability of (maximum) cycloplegia and changes in astigmatism. Differences will be considered statistical significant if p 0.50 D, a time difference in stability of > 10 minutes, and a change of > 0.50 D cylinder or a change of >5° cylinder ax will be considered clinical significant. Part II Primary outcome parameter is ti | — |
Countries
Netherlands
Outcome results
None listed