Keratoconus, StableKPLNCT05220904
Perceptual Learning Improve Visual Function in Patients With Keratoconus
A study testing spectacles and perceptual learning in people with Keratoconus, Stable, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Keratoconus, Stable
- What is being tested?
- spectacles and perceptual learning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Study other reasons that the physician considers inappropriate for inclusion in the program.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: A Randomized Controlled Clinical Study of Perceptual Learning Improving Visual Function in Patients With Keratoconus
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
- Being tested
- spectacles, perceptual learning
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectaclesDevice
Spectacle is the the most common treatment for refractive errors.
perceptual learningDevice
Blurred vision from the eyes can be improved by enhancing the brain's visual processing.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator:placebo practice+spectacles | Placebo comparator | Patients will take placebo practices with spectacles every two days. Receives: Device: spectacles |
| Experimental： perceptual learning practice+spectacles | Experimental | Patients will take perceptual learning practices with spectacles every two days. Receives: Device: spectacles; Device: perceptual learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-months corrected visual acuity
Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.
Measured: baseline；3 months.
Secondary outcomes (3)
corrected visual acuity of other time frame
Mean changes of best corrected visual acuity for 6,9,15 months.
Measured: 6,9,15 months
ucorrected visual acuity (UCVA)
Mean changes of ucorrected visual acuity (UCVA) for 3,6,9,15 months.
Measured: 3,6,9,15 months
contrast sensitivity function (CSF)
Mean changes of contrast sensitivity function (CSF) for 3,6,9,15 months.
Measured: 3,6,9,15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start5 Feb 2022
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconus, StableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao Yang, Professor, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220904
- Sponsor's protocol ID
- 2021KYPJ203
- Acronym
- KPL
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study of Perceptual Learning Improving Visual Function in Patients With Keratoconus
- ClinicalTrials.gov ID
- NCT05220904
- Acronym / sponsor ID
- KPL / 2021KYPJ203
- Conditions
- Keratoconus, Stable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator:placebo practice+spectacles | Placebo comparator | Device: spectaclesPatients will take placebo practices with spectacles every two days. |
| Experimental： perceptual learning practice+spectacles | Experimental | Device: spectacles, Device: perceptual learningPatients will take perceptual learning practices with spectacles every two days. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectaclesSpectacle is the the most common treatment for refractive errors. | Device | Experimental： perceptual learning practice+spectacles, Placebo Comparator:placebo practice+spectacles |
| perceptual learningBlurred vision from the eyes can be improved by enhancing the brain's visual processing. | Device | Experimental： perceptual learning practice+spectacles |
Primary outcome
3-months corrected visual acuity
Time frame: baseline；3 months.
Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.
3 secondary outcomes
corrected visual acuity of other time frame
Time frame: 6,9,15 months
ucorrected visual acuity (UCVA)
Time frame: 3,6,9,15 months
contrast sensitivity function (CSF)
Time frame: 3,6,9,15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Related trials for Keratoconus, Stable
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Yang, Professor study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spectacles and perceptual learning in people with Keratoconus, Stable, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-months corrected visual acuity (time frame: baseline；3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.