- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360161
Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age
April 21, 2020 updated by: Yune Zhao, Wenzhou Medical University
Morphology of Schlemm's Canal and Crystalline Lens in Different Age: a Swept-source Optical Coherence Tomography Study
The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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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Hangzhou, Zhejiang, China, 325027
- Eye Hospital of WMU
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-
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
7 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy patients who can cooperated with the swept-source OCT measurements
Exclusion Criteria:
- history of ocular disease
- presence of central nervous system or systemic disease
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
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy participants
Swept-source optical coherence tomography A device testing TM/SC and Lens morphology
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Aswe pt-source OCT (CASIA SS-1000; Tomey Corporation, Nagoya, Japan), which is specifically designed for anterior segment imaging using a 1310 nm wavelength with a scan speed of 30,000 A-scans per second and an axial resolution of <10 μm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
area of Schlemm's canal and trabecular meshwork
Time Frame: up to 6 months
|
The area of Schlemm's canal and trabecular meshwork was manually measured and the relationship between the parameters and age was analyzed.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yune Zhao, Eye Hospital of Wenzhou Medical University
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)
August 8, 2019
Primary Completion (Actual)
December 20, 2019
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- TM/SC/Lens-LZL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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