Clinical trial NCT04576884: Age-Related Changes and Cycloplegia-Induced Differences in the Human Crystalline Lens
Official title: Age-Related Changes and Cycloplegia-Induced Differences of the Human Crystalline Lens, Schlemm' s Canal and Trabecular Meshwork：an in Vivo Swept-Source Optical Coherence Tomography Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: radius of curvature
lens thickness
equatorial diameter
lens vault
cycloplegia
swept-source optical coherence tomography
schlemm' s canal
trabecular meshwork
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 129
Sex: ALL
Minimum age (years): 6
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) at Eye hospital of Wenzhou Medical University

Brief summary: The ocular biometric parameters of the human crystalline lens including anterior chamber depth (ACD), lens thickness (LT), radii of curvature of anterior and posterior lens (ALR and PLR), lens equatorial diameter (LED), and lens vault (LV), automatically quantified by the CASIA2 (SS-OCT; Tomey, Nagoya, Japan). Images of iridocorneal angle were obtained using CASIA2 and the Schlemm' s canal (SC) and trabecular meshwork (TM) were quantified manually. Both cycloplegia and non-cycloplegia images were obtained.

Detailed description: Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia), were consecutively included from April to May 2019. All participants underwent visual acuity, dry and wet refraction, anterior and posterior segment examination, intraocular pressure (IOP), and axial length (AL) using IOL-Master 700 (Carl Zeiss Meditec AG). Investigators recruited children under 18 years old at a refraction outpatient clinic, who were prescribed cyclopentolate hydrochloride eyedrops (S.A. Alcon-Couvreur N.V., Belguim) for cycloplegic refraction. For adults, they were prescribed compound tropicamide eyedrops (Mydrin-P, Santen Pharmaceutical Co., Ltd, Osaka, Japan), consisting of 0.5% tropicamide mixed with 0.5% phenylephrine hydrochloride, for pupillary dilation in order to perform fundus examination at an outpatient clinic. Exclusion criteria were as follow:ocular diseases other than cataracts; history of eye surgeries or injuries; shallow anterior chamber with a risk of angle closure. The data from right eye was selected for analysis.

Eligibility criteria: Inclusion Criteria:

Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) Must be able to cooperate examination

Exclusion Criteria:

ocular diseases other than cataracts history of eye surgeries or injuries shallow anterior chamber with a risk of angle closure

Primary outcomes:
measure: Paired Comparison Before and After Cycloplegia
timeFrame: 2020.2.3
measure: Evaluated the effect of age on the TM/SC morphologies
timeFrame: 2020.2.3
Secondary outcomes:
measure: Evaluated the effect of age on the ocular biometric data
timeFrame: 2020.2.3
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
affiliation: Ophthalmology and Optometry Hospital
name: Yune Zhao
role: STUDY_DIRECTOR
References:
citation: Li Z, Meng Z, Qu W, Li X, Chang P, Wang D, Zhao Y. The Relationship Between Age and the Morphology of the Crystalline Lens, Ciliary Muscle, Trabecular Meshwork, and Schlemm's Canal: An in vivo Swept-Source Optical Coherence Tomography Study. Front Physiol. 2021 Nov 19;12:763736. doi: 10.3389/fphys.2021.763736. eCollection 2021.