NCT03735602

Brief Summary

This study is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

October 24, 2018

Last Update Submit

May 16, 2020

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (2)

  • The change of the contrast sensitivity function tested by quick CSF

    The quick CSF (contrast sensitivity function) measures contrast threshold by fitting raw data and calculating the Cutoff sensitivity frequency.

    eight months

  • The change of contrast threshold tested by sweep visually evoked potential (VEP)

    The contrast threshold was calculated by analyzing EEG(Electroencephalogram) data recorded with sweep visually evoked potential (VEP) paradigm.

    eight months

Study Arms (1)

perceptual training

EXPERIMENTAL

Orientation discrimination task, which is a cognitive task. Patients were trained for 1 hour per day, 15 days in total.

Behavioral: perceptual training

Interventions

perceptual trainingBEHAVIORAL

orientation discrimination task

perceptual training

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • high astigmatism

You may not qualify if:

  • other types of disease (especially optical diseases) that may affect study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Jin Yuan, Professor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Li Gu, Phd

CONTACT

15889937313guli7@mail2.sysu.edu.cn

Jin Yuan, Professor

CONTACT

2087333391yuanjincornea@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 8, 2018

Study Start

July 1, 2019

Primary Completion

March 1, 2021

Study Completion

December 1, 2021

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

CN(1)