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Completed

NCT Number: NCT04576884

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

6 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Paired Comparison Before and After Cycloplegia

    Time frame: 2020.2.3

    The cycloplegia-induced differences of parameters was defined as: the post-cycloplegic value minus the pre-cycloplegic value.

  2. Evaluated the effect of age on the TM/SC morphologies

    Time frame: 2020.2.3

    The age-related variations of TM/SC parameters from four age groups were compared.

Secondary outcomes

  1. Evaluated the effect of age on the ocular biometric data

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 6, 2020
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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