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

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Keratoconus, Stable

Treatments: Device: perceptual learning; Device: spectacles

Study type: Interventional

Funder types: Other

Identifiers

NCT05220904

2021KYPJ203

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

54 participants in 2 patient groups, including a placebo group

Placebo Comparator:placebo practice+spectacles

Placebo Comparator group

Description:

Patients will take placebo practices with spectacles every two days.

Treatment:

Device: spectacles

Experimental： perceptual learning practice+spectacles

Experimental group

Description:

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

Treatment:

Device: spectacles

Device: perceptual learning