Neural Mechanisms Underlying Astigmatism
Primary Purpose
Astigmatism
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
perceptual training
Sponsored by
About this trial
This is an interventional basic science trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- high astigmatism
Exclusion Criteria:
- other types of disease (especially optical diseases) that may affect study
Sites / Locations
- Zhongshan Ophthalmic CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
perceptual training
Arm Description
Orientation discrimination task, which is a cognitive task. Patients were trained for 1 hour per day, 15 days in total.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03735602
First Posted
October 24, 2018
Last Updated
May 16, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03735602
Brief Title
Neural Mechanisms Underlying Astigmatism
Official Title
The Research of the Neural Mechanisms Underlying Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. However, the neural mechanisms underlying the astigmatism remains unknown. The current study recruited three groups (patients with with-the-rule astigmatism and amblyopia, patients with with-the-rule astigmatism but without amblyopia, normal controls) of subjects and patients receive perceptual learning training (orientation discrimination task) which lasts for around 15 days. This main aim 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.
Patients with astigmatism or amblyopia were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
perceptual training
Arm Type
Experimental
Arm Description
Orientation discrimination task, which is a cognitive task. Patients were trained for 1 hour per day, 15 days in total.
Intervention Type
Behavioral
Intervention Name(s)
perceptual training
Intervention Description
orientation discrimination task
Primary Outcome Measure Information:
Title
The change of the contrast sensitivity function tested by quick CSF
Description
The quick CSF (contrast sensitivity function) measures contrast threshold by fitting raw data and calculating the Cutoff sensitivity frequency.
Time Frame
eight months
Title
The change of contrast threshold tested by sweep visually evoked potential (VEP)
Description
The contrast threshold was calculated by analyzing EEG(Electroencephalogram) data recorded with sweep visually evoked potential (VEP) paradigm.
Time Frame
eight months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
high astigmatism
Exclusion Criteria:
other types of disease (especially optical diseases) that may affect study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Gu, Phd
Phone
15889937313
Ext
+86
Email
guli7@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Yuan, Professor
Phone
2087333391
Email
yuanjincornea@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Yuan, Professor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Gu, Dr.
Phone
15889937313
Ext
+86
Email
guli7@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jin yuan, Prof.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neural Mechanisms Underlying Astigmatism
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