Perceptual Learning Improve Visual Function in Patients With Keratoconus

NCT ID: NCT05220904

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2024-12-30

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.

Conditions

Keratoconus, Stable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo Comparator:placebo practice+spectacles

Patients will take placebo practices with spectacles every two days.

Group Type: PLACEBO_COMPARATOR

spectacles

Intervention Type: DEVICE

Spectacle is the the most common treatment for refractive errors.

Experimental： perceptual learning practice+spectacles

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

Group Type: EXPERIMENTAL

spectacles

Intervention Type: DEVICE

Spectacle is the the most common treatment for refractive errors.

perceptual learning

Intervention Type: DEVICE

Blurred vision from the eyes can be improved by enhancing the brain's visual processing.

Interventions

spectacles

Spectacle is the the most common treatment for refractive errors.

Intervention Type: DEVICE

perceptual learning

Blurred vision from the eyes can be improved by enhancing the brain's visual processing.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao Yang, Professor

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2021KYPJ203

Identifier Type: -

Identifier Source: org_study_id