Age-Related Changes and Cycloplegia-Induced Differences in the Human Crystalline Lens

Completed

• Conditions: Cataract

• Registration Number: NCT04576884
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-05-31
• Study Completion: 2020-01-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study First Posted: 2020-10-06
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Paired Comparison Before and After Cycloplegia	2020.2.3	The cycloplegia-induced differences of parameters was defined as: the post-cycloplegic value minus the pre-cycloplegic value.
Evaluated the effect of age on the TM/SC morphologies	2020.2.3	The age-related variations of TM/SC parameters from four age groups were compared.

Secondary Outcome Measures

Name	Time	Method
Evaluated the effect of age on the ocular biometric data	2020.2.3	The age-related variations of ocular biometric data such as axial length (AL), lens thickness (LT), and anterior chamber depth (ACD) from four age groups were compared.

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China