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

A Randomized Controlled Clinical Study of Perceptual Learning Improving Visual Function in Patients With Keratoconus

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Keratoconus, Stable
• Intervention / Treatment: Device: spectacles; Device: perceptual learning

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator:placebo practice+spectacles; Patients will take placebo practices with spectacles every two days.	Device: spectacles; Spectacle is the the most common treatment for refractive errors.
Experimental: Experimental： perceptual learning practice+spectacles; Patients will take perceptual learning practices with spectacles every two days.	Device: spectacles; Spectacle is the the most common treatment for refractive errors.; Device: perceptual learning; Blurred vision from the eyes can be improved by enhancing the brain's visual processing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-months corrected visual acuity	Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.	baseline；3 months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Chair: Xiao Yang, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: 2021KYPJ203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No