Myopia (Disorder)NCT07778264
Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia
An observational study of Myopia (Disorder) and Anisometropia, run by Buddhist Tzu Chi General Hospital.
Trial summary
This investigator-initiated prospective observational cohort study aims to establish the first longitudinal clinical database evaluating fellow-eye myopia development in children receiving monocular MiSight® 1 Day treatment for unilateral myopia. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Myopia (Disorder), Anisometropia
- What is being tested?
- MiSight® 1 Day
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2029
- How long will I take part?
- 100 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children aged 7-18 years with unilateral myopia who meet all eligibility criteria and whose parents/legal guardians provide written informed consent. The myopic eye must have a cycloplegic SER of ≤ -0.75 D, while the fellow eye must have a cycloplegic SER of > -0.50 D. The myopic eye must have cylinder ≤1.00 D and BCVA of 20/25 or better. Participants must be willing to wear MiSight® 1 Day for at least 10 hours per day and 6 days per week and complete 12 months of follow-up.
Who may be able to join
- Age 7-18 years.
- Cycloplegic SER ≤ -0.75 D in one eye and > -0.50 D in the fellow eye.
- Cylinder ≤1.00 D in the myopic eye.
- BCVA ≥20/25 (0.1 logMAR).
- Willingness to wear MiSight® 1 Day for ≥10 hours/day and ≥6 days/week.
- Willingness of the participant and parents to comply with the study procedures and complete 12 months of follow-up.
- Written informed consent provided by the legal guardian.
Who cannot join
- Previous orthokeratology treatment.
- Previous atropine treatment exceeding one month.
- Previous use of other myopia-control soft contact lenses.
- Keratoconus, corneal degeneration, or other corneal disease.
- Amblyopia, strabismus, or other significant binocular visual dysfunction.
- Cataract, glaucoma, uveitis, retinal disease, or other significant ocular disease.
Show all 9Show fewer
- Systemic connective-tissue or neurological disease affecting vision.
- Known allergy to atropine or contact lens materials.
- Inability to comply with scheduled visits or anticipated relocation during the study period.
About this study
Official title: Natural History and Post-Conversion Clinical Outcomes of the Fellow Eye in Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia: A Prospective Cohort Study
This investigator-initiated prospective observational cohort study aims to establish the first longitudinal clinical database evaluating fellow-eye myopia development in children receiving monocular MiSight® 1 Day treatment for unilateral myopia.
All myopic eyes will receive MiSight® 1 Day as standard clinical care, while the fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution, will be initiated according to routine clinical practice and shared decision-making between the investigator and the child's parents The findings are expected to provide important evidence regarding fellow-eye refractive development, identify predictors of myopia conversion, optimize the timing of intervention, and support personalized myopia management in children with unilateral myopia.
- Conditions
- Myopia (Disorder), Anisometropia
- Being tested
- MiSight® 1 Day
- Medical subject headings
- Myopia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiSight® 1 DayDevice
Unilateral myopia children receive MiSight® 1 Day treatment in the myopic eye， fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution
What is being measured
The primary outcome is the main question the study is designed to answer.
PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment.
Measured: From enrollment to the end of treatment at 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia (Disorder)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 100 Months
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778264
- Sponsor's protocol ID
- IRB 115-
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Post-Conversion Clinical Outcomes of the Fellow Eye in Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07778264
- Acronym / sponsor ID
- IRB 115-
- Conditions
- Myopia (Disorder), Anisometropia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Aug 2026 (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 investigator-initiated prospective observational cohort study aims to establish the first longitudinal clinical database evaluating fellow-eye myopia development in children receiving monocular MiSight® 1 Day treatment for unilateral myopia.
All myopic eyes will receive MiSight® 1 Day as standard clinical care, while the fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution, will be initiated according to routine clinical practice and shared decision-making between the investigator and the child's parents The findings are expected to provide important evidence regarding fellow-eye refractive development, identify predictors of myopia conversion, optimize the timing of intervention, and support personalized myopia management in children with unilateral myopia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Months
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children aged 7-18 years with unilateral myopia who meet all eligibility criteria and whose parents/legal guardians provide written informed consent. The myopic eye must have a cycloplegic SER of ≤ -0.75 D, while the fellow eye must have a cycloplegic SER of > -0.50 D. The myopic eye must have cylinder ≤1.00 D and BCVA of 20/25 or better. Participants must be willing to wear MiSight® 1 Day for at least 10 hours per day and 6 days per week and complete 12 months of follow-up.
Key inclusion criteria (7 listed)
- Age 7-18 years.
- Cycloplegic SER ≤ -0.75 D in one eye and > -0.50 D in the fellow eye.
- Cylinder ≤1.00 D in the myopic eye.
- BCVA ≥20/25 (0.1 logMAR).
- Willingness to wear MiSight® 1 Day for ≥10 hours/day and ≥6 days/week.
Key exclusion criteria (9 listed)
- Previous orthokeratology treatment.
- Previous atropine treatment exceeding one month.
- Previous use of other myopia-control soft contact lenses.
- Keratoconus, corneal degeneration, or other corneal disease.
- Amblyopia, strabismus, or other significant binocular visual dysfunction.
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 |
|---|---|---|
| MiSight® 1 DayUnilateral myopia children receive MiSight® 1 Day treatment in the myopic eye， fellow eye will undergo regular observation without prophylactic intervention. If the fellow eye develops myopia (cycloplegic spherical equivalent ≤ -0.50 D), standard myopia control treatment, including MiSight® 1 Day or 0.05% atropine ophthalmic solution | Device | – |
Primary outcome
PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment.
Time frame: From enrollment to the end of treatment at 12 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Related trials for Myopia (Disorder)
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia (Disorder) and Anisometropia, run by Buddhist Tzu Chi General Hospital.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
PERCENTAGE OF fellow-eye myopia development in children with unilateral myopia receiving monocular MiSight® 1 Day treatment. (time frame: From enrollment to the end of treatment at 12 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 21 Aug 2026.