NCT04576884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 21, 2020

Last Update Submit

September 30, 2020

Conditions

Keywords

radius of curvaturelens thicknessequatorial diameterlens vaultcycloplegiaswept-source optical coherence tomographyschlemm' s canaltrabecular meshwork

Outcome Measures

Primary Outcomes (2)

  • Paired Comparison Before and After Cycloplegia

    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

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

    2020.2.3

Secondary Outcomes (1)

  • Evaluated the effect of age on the ocular biometric data

    2020.2.3

Study Arms (4)

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

Eligibility Criteria

Age6 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • ocular diseases other than cataracts history of eye surgeries or injuries shallow anterior chamber with a risk of angle closure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (1)

  • Li Z, Meng Z, Qu W, Li X, Chang P, Wang D, Zhao Y. The Relationship Between Age and the Morphology of the Crystalline Lens, Ciliary Muscle, Trabecular Meshwork, and Schlemm's Canal: An in vivo Swept-Source Optical Coherence Tomography Study. Front Physiol. 2021 Nov 19;12:763736. doi: 10.3389/fphys.2021.763736. eCollection 2021.

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Yune Zhao

    Ophthalmology and Optometry Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

September 21, 2020

First Posted

October 6, 2020

Study Start

April 1, 2019

Primary Completion

May 31, 2019

Study Completion

January 30, 2020

Last Updated

October 6, 2020

Record last verified: 2020-09

Locations