Perceptual Learning Improve Visual Function in Patients With Keratoconus

NCT05220904 | Unknown

• 1 other identifier: 2021KYPJ203
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• corrected visual acuity of other time frame

  6,9,15 months

• ucorrected visual acuity (UCVA)

  3,6,9,15 months

• contrast sensitivity function (CSF)

  3,6,9,15 months

Study Arms (2)

Placebo Comparator:placebo practice+spectacles

PLACEBO COMPARATOR

Patients will take placebo practices with spectacles every two days.

Device: spectacles

Experimental： perceptual learning practice+spectacles

EXPERIMENTAL

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

Device: spectacles; Device: perceptual learning

Interventions

spectacles DEVICE

Spectacle is the the most common treatment for refractive errors.

Experimental： perceptual learning practice+spectacles; Placebo Comparator:placebo practice+spectacles

perceptual learning DEVICE

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

Experimental： perceptual learning practice+spectacles

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 9 years or older;
• Has been diagnosed as Keratoconus,BAD-D≥2.6;
• Change of Kmax \< 1.0 D and change of BAD-D \<0.4175 betweem the last two Pentacam result;
• The best corrected visual acuity of both eyes was between 0.1 and 1.0;
• Has voluntarily agreed to participate in the study by signing the statement of informed consent.

You may not qualify if:

• Has history of acute keratoconus;
• Has other eye diseases or other diseases/conditions causing vision loss;
• Has eye surgery history in the past 1year;
• Is currently using local/systemic medications or other interventions that may affect visual function;
• Receiving other treatments that may affect the results of this study, such as contact lenses during the study;
• Has any known neurological diseases;
• Participating in other studies currently that may affect the results of this study;

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Xiao Yang, Professor

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: February 5, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 23, 2024

Record last verified: 2023-11

Locations

CN (1)