MyopiaNCT06744478
Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens
An observational study of Myopia and Anisometropia, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The effectiveness of Misight 1 Day Contact Lens in retarding anisometropic progression has not been investigated before. This study is aimed to elucidate the efficacy of Misight 1 Day Contact Lens for anisometropia control. Read more about this study
- Who is it for?
- Ages 8 to 23 years
- Conditions the study is for
- Myopia, Anisometropia
- What is being tested?
- Misight 1 Day Contact Lens
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Dec 2026
- How long will I take part?
- 3 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 8 to 23 years
- All sexes
- Child, Adult
Study population: We enroll the clinical patients who was diagnosed with anisometropia (meaning that myopia exceeds 100 degree diopters during the refraction examination, and the difference between the other eye is more than 100 degree diopters). Age limit was 8 to 23 years old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.
Who may be able to join
- 8-23 years old children diagnosed with anisometropia and are willing to accept MiSight® 1 Day contact lens wearing treatment.
- No congenital eye diseases or eye diseases such as strabismus and amblyopia.
- Those who have been stated to be willing to participate in the program for at least 24 months and accept various evaluations.
Who cannot join
- Ocular surface disease( dry eye, keratoconus..)
- Allergy to contact lens
- Received eye surgery before
- The cornea is infected (bacterial, fungal or viral infection).
- Strabismus
- Premature birth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The effectiveness of Misight 1 Day Contact Lens in retarding anisometropic progression has not been investigated before. This study is aimed to elucidate the efficacy of Misight 1 Day Contact Lens for anisometropia control.
- Conditions
- Myopia, Anisometropia
- Being tested
- Misight 1 Day Contact Lens
- 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 Day Contact LensDevice
Misight 1 Day Contact Lens wearing for myopia control
| Study group | Role | What they receive |
|---|---|---|
| myopic children | Myopic children use Misight 1 Day Contact Lens every day for myopia and anisometropia control. Receives: Device: Misight 1 Day Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the visual acuity in myopic children with different Misight 1 Day Contact Lens
The investigators measure the visual acuity of myopic children with different Misight 1 Day Contact Lens.
Measured: From the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.
Secondary outcomes (1)
Changes of axial length in myopic children with different Misight 1 Day Contact Lens
The investigators measure the axial length(mm) of eyeball of myopic children with different diopter of Misight 1 Day Contact Lens.
Measured: From the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 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
- NCT06744478
- Sponsor's protocol ID
- IRB113-170-A
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens
- ClinicalTrials.gov ID
- NCT06744478
- Acronym / sponsor ID
- IRB113-170-A
- Conditions
- Myopia, Anisometropia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Dec 2024 (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.
The effectiveness of Misight 1 Day Contact Lens in retarding anisometropic progression has not been investigated before. This study is aimed to elucidate the efficacy of Misight 1 Day Contact Lens for anisometropia control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myopic children | – | Device: Misight 1 Day Contact LensMyopic children use Misight 1 Day Contact Lens every day for myopia and anisometropia control. |
Who may qualify
- Ages
- 8 to 23 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- We enroll the clinical patients who was diagnosed with anisometropia (meaning that myopia exceeds 100 degree diopters during the refraction examination, and the difference between the other eye is more than 100 degree diopters). Age limit was 8 to 23 years old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.
Key inclusion criteria (3 listed)
- 8-23 years old children diagnosed with anisometropia and are willing to accept MiSight® 1 Day contact lens wearing treatment.
- No congenital eye diseases or eye diseases such as strabismus and amblyopia.
- Those who have been stated to be willing to participate in the program for at least 24 months and accept various evaluations.
Key exclusion criteria (6 listed)
- Ocular surface disease( dry eye, keratoconus..)
- Allergy to contact lens
- Received eye surgery before
- The cornea is infected (bacterial, fungal or viral infection).
- Strabismus
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 Day Contact LensMisight 1 Day Contact Lens wearing for myopia control | Device | myopic children |
Primary outcome
Changes of the visual acuity in myopic children with different Misight 1 Day Contact Lens
Time frame: From the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.
The investigators measure the visual acuity of myopic children with different Misight 1 Day Contact Lens.
1 secondary outcome
Changes of axial length in myopic children with different Misight 1 Day Contact Lens
Time frame: From the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 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 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Myopia
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
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Anisometropia, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 20 Dec 2024. 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 Taiwan. 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. 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?
Changes of the visual acuity in myopic children with different Misight 1 Day Contact Lens (time frame: From the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 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 20 Dec 2024.