NCT04487795

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

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 15, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

15 days

First QC Date

July 23, 2020

Last Update Submit

July 23, 2020

Conditions

Crystalline CataractLens; Anomaly

Keywords

crystalline lens tiltcrystalline lens decentrationswept-source optical coherence tomography

Outcome Measures

Primary Outcomes (2)

  • crystalline lens tilt

    magnitude and direction of crystalline lens lilt

    2020.4.30

  • crystalline lens decentration

    magnitude and direction of crystalline lens decentration

    2020.4.30

Study Arms (4)

under 18 years old

18-40 years old

41-60 years old

over 60 years old

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou Medical University

You may qualify if:

  • healthy volunteers and patients with age-related cataract

You may not qualify if:

  • aphakia or pseudophakia
  • any other ocular diseases with the exception of senile cataract
  • any history of ocular surgery
  • fixation difficulties caused by any reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

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

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 27, 2020

Study Start

April 15, 2020

Primary Completion

April 30, 2020

Study Completion

May 17, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

CN(1)