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Perceptual Learning Improve Visual Function in Patients With Keratoconus

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05220904
Acronym
KPL
Enrollment
54
Registered
2022-02-02
Start date
2022-02-05
Completion date
2024-12-30
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus, Stable

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.

Interventions

DEVICEspectacles

Spectacle is the the most common treatment for refractive errors.

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

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
3-months corrected visual acuitybaseline;3 months.Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.

Secondary

MeasureTime frameDescription
corrected visual acuity of other time frame6,9,15 monthsMean changes of best corrected visual acuity for 6,9,15 months.
ucorrected visual acuity (UCVA)3,6,9,15 monthsMean changes of ucorrected visual acuity (UCVA) for 3,6,9,15 months.
contrast sensitivity function (CSF)3,6,9,15 monthsMean changes of contrast sensitivity function (CSF) for 3,6,9,15 months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026