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Perceptual Learning Improve Visual Function in Patients With Keratoconus (KPL)

Primary Purpose

Keratoconus, Stable

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
spectacles
perceptual learning
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Keratoconus, Stable

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 9 years or older;
  2. Has been diagnosed as Keratoconus,BAD-D≥2.6;
  3. Change of Kmax < 1.0 D and change of BAD-D <0.4175 betweem the last two Pentacam result;
  4. The best corrected visual acuity of both eyes was between 0.1 and 1.0;
  5. Has voluntarily agreed to participate in the study by signing the statement of informed consent.

Exclusion Criteria:

  1. Has history of acute keratoconus;
  2. Has other eye diseases or other diseases/conditions causing vision loss;
  3. Has eye surgery history in the past 1year;
  4. Is currently using local/systemic medications or other interventions that may affect visual function;
  5. Receiving other treatments that may affect the results of this study, such as contact lenses during the study;
  6. Has any known neurological diseases;
  7. Participating in other studies currently that may affect the results of this study;
  8. Study other reasons that the physician considers inappropriate for inclusion in the program.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Comparator:placebo practice+spectacles

Experimental： perceptual learning practice+spectacles

Arm Description

Patients will take placebo practices with spectacles every two days.

Patients will take perceptual learning practices with spectacles every two days.

Outcomes

Primary Outcome Measures

3-months corrected visual acuity
Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.

Secondary Outcome Measures

corrected visual acuity of other time frame
Mean changes of best corrected visual acuity for 6,9,15 months.
ucorrected visual acuity (UCVA)
Mean changes of ucorrected visual acuity (UCVA) for 3,6,9,15 months.
contrast sensitivity function (CSF)
Mean changes of contrast sensitivity function (CSF) for 3,6,9,15 months.

Full Information

First Posted
January 21, 2022
Last Updated
February 20, 2022
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05220904
Brief Title
Perceptual Learning Improve Visual Function in Patients With Keratoconus
Acronym
KPL
Official Title
A Randomized Controlled Clinical Study of Perceptual Learning Improving Visual Function in Patients With Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 project aims at non-progressive keratoconus patients with unsatisfactory visual acuity corrected by spectacles, and explores the effectiveness and maintenance of visual acuity improved by perceptual learning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Stable

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator:placebo practice+spectacles
Arm Type
Placebo Comparator
Arm Description
Patients will take placebo practices with spectacles every two days.
Arm Title
Experimental： perceptual learning practice+spectacles
Arm Type
Experimental
Arm Description
Patients will take perceptual learning practices with spectacles every two days.
Intervention Type
Device
Intervention Name(s)
spectacles
Intervention Description
Spectacle is the the most common treatment for refractive errors.
Intervention Type
Device
Intervention Name(s)
perceptual learning
Intervention Description
Blurred vision from the eyes can be improved by enhancing the brain's visual processing.
Primary Outcome Measure Information:
Title
3-months corrected visual acuity
Description
Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.
Time Frame
baseline；3 months.
Secondary Outcome Measure Information:
Title
corrected visual acuity of other time frame
Description
Mean changes of best corrected visual acuity for 6,9,15 months.
Time Frame
6,9,15 months
Title
ucorrected visual acuity (UCVA)
Description
Mean changes of ucorrected visual acuity (UCVA) for 3,6,9,15 months.
Time Frame
3,6,9,15 months
Title
contrast sensitivity function (CSF)
Description
Mean changes of contrast sensitivity function (CSF) for 3,6,9,15 months.
Time Frame
3,6,9,15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 9 years or older; Has been diagnosed as Keratoconus,BAD-D≥2.6; Change of Kmax < 1.0 D and change of BAD-D <0.4175 betweem the last two Pentacam result; The best corrected visual acuity of both eyes was between 0.1 and 1.0; Has voluntarily agreed to participate in the study by signing the statement of informed consent. Exclusion Criteria: Has history of acute keratoconus; Has other eye diseases or other diseases/conditions causing vision loss; Has eye surgery history in the past 1year; Is currently using local/systemic medications or other interventions that may affect visual function; Receiving other treatments that may affect the results of this study, such as contact lenses during the study; Has any known neurological diseases; Participating in other studies currently that may affect the results of this study; Study other reasons that the physician considers inappropriate for inclusion in the program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Yang, Professor
Phone
86-020-87330348
Email
yangx_zoc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Yang, Professor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Yang, PhD

12. IPD Sharing Statement

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Perceptual Learning Improve Visual Function in Patients With Keratoconus

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