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

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 Overview

• Status: Enrolling by invitation
• Conditions: Myopia; Anisometropia
• Intervention / Treatment: Device: Misight 1 Day Contact Lens

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan, 97002
    • Shang-Yen WU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
myopic children; Myopic children use Misight 1 Day Contact Lens every day for myopia and anisometropia control.	Device: Misight 1 Day Contact Lens; Misight 1 Day Contact Lens wearing for myopia control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Anisometropia
• Other Study ID Numbers: IRB113-170-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes