- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04576884
Age-Related Changes and Cycloplegia-Induced Differences in the Human Crystalline Lens
September 30, 2020 updated by: Yune Zhao, Wenzhou Medical University
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
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
129
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Wenzhou, Zhejiang, China, 325027
- Ophthalmology and Optometry Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 86 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2020.2.3
|
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.
|
2020.2.3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2020.2.3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
January 30, 2020
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 6, 2020
Study Record Updates
Last Update Posted (Actual)
October 6, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSOCT-ocular parameters change
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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