- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487795
Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study
July 23, 2020 updated by: Yune Zhao
230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study.
230 right eyes and 88 left eyes were included for the measurement.
All the measurements were performed under non-mydriatic conditions in a dim examination room using the CASIA2 swept-source AS-OCT system.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
230
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
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou Medical University
Description
Inclusion Criteria:
- healthy volunteers and patients with age-related cataract
Exclusion Criteria:
- aphakia or pseudophakia
- any other ocular diseases with the exception of senile cataract
- any history of ocular surgery
- fixation difficulties caused by any reasons
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 |
|---|
|
under 18 years old
|
|
18-40 years old
|
|
41-60 years old
|
|
over 60 years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
crystalline lens tilt
Time Frame: 2020.4.30
|
magnitude and direction of crystalline lens lilt
|
2020.4.30
|
|
crystalline lens decentration
Time Frame: 2020.4.30
|
magnitude and direction of crystalline lens decentration
|
2020.4.30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 15, 2020
Primary Completion (ACTUAL)
April 30, 2020
Study Completion (ACTUAL)
May 17, 2020
Study Registration Dates
First Submitted
July 23, 2020
First Submitted That Met QC Criteria
July 23, 2020
First Posted (ACTUAL)
July 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 23, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSOCT-lens tilt
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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