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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04576884
Recruitment Status : Completed
First Posted : October 6, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Yune Zhao, Wenzhou Medical University

Study Description
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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
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
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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 : April 1, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : January 30, 2020
Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 86 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576884


Locations
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China, Zhejiang
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Study Director: Yune Zhao Ophthalmology and Optometry Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04576884    
Other Study ID Numbers: SSOCT-ocular parameters change
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yune Zhao, Wenzhou Medical University:
radius of curvature
lens thickness
equatorial diameter
lens vault
 cycloplegia
swept-source optical coherence tomography
schlemm' s canal
trabecular meshwork
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases