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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04576884

Collaborator

(none)

129

Enrollment

Location

Actual Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract

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 Design

Study Type:

Observational

Actual Enrollment :

129 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group 1 participants of less than 18 years old
Group 2 participants aged from 18 years to 40 year
Group 3 participants aged from 41 years to 60 years
Group 4 participants over 60 years old

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 86 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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