Perceptual Learning Improve Visual Function in Patients With Keratoconus

Not Applicable

Active, not recruiting

• Conditions: Keratoconus, Stable
• Interventions: Device: spectacles; Device: perceptual learning

• Registration Number: NCT05220904
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2022-02-05
• Status Verified: 2023-11
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator:placebo practice+spectacles	spectacles	Patients will take placebo practices with spectacles every two days.
Experimental： perceptual learning practice+spectacles	perceptual learning	Patients will take perceptual learning practices with spectacles every two days.
Experimental： perceptual learning practice+spectacles	spectacles	Patients will take perceptual learning practices with spectacles every two days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China