Perceptual Learning Improve Visual Function in Patients With Keratoconus

Keratoconus, Stable Clinical Trial

— KPL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05220904
• Other study ID #: 2021KYPJ203
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keratoconus
• Keratoconus, Stable

Intervention

Device:
• spectacles
Spectacle is the the most common treatment for refractive errors.
• perceptual learning
Blurred vision from the eyes can be improved by enhancing the brain's visual processing.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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