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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576884
• Other study ID #: SSOCT-ocular parameters change
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2020
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 30, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired Comparison Before and After Cycloplegia	The cycloplegia-induced differences of parameters was defined as: the post-cycloplegic value minus the pre-cycloplegic value.	2020.2.3
Primary	Evaluated the effect of age on the TM/SC morphologies	The age-related variations of TM/SC parameters from four age groups were compared.	2020.2.3
Secondary	Evaluated the effect of age on the ocular biometric data	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.	2020.2.3