Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens

NCT06744478 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: IRB113-170-A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; Anisometropia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months

Study Arms (1)

myopic children

Myopic children use Misight 1 Day Contact Lens every day for myopia and anisometropia control.

Device: Misight 1 Day Contact Lens

Interventions

Misight 1 Day Contact Lens DEVICE

Misight 1 Day Contact Lens wearing for myopia control

myopic children

Eligibility Criteria

• Age: 8 Years - 23 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Shang-Yen WU

Hualien City, 97002, Taiwan

Location

MeSH Terms

Conditions

Myopia; Anisometropia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

TW (1)