A Comparative Study of the Efficacy of Myopia Control Lenses With Different Mechanisms on Controlling Myopia Progression in Patients With Intermittent Exotropia

NCT07642934 | Not Yet Recruiting

• 1 other identifier: 2025-1537
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare the efficacy of myopia control lenses with different working principles in patients with intermittent exotropia aged 6 to 12 years. The main questions it aims to answer are: Are there any differences in the clinical outcomes of DIMS and DOT glasses between children with intermittent exotropia and those with simple myopia (without intermittent exotropia)? Do DIMS and DOT glasses differ in their myopia control efficacy among children with intermittent exotropia? Does wearing DIMS or DOT glasses affect the binocular visual function of children with intermittent exotropia?

Conditions

Intermittent Exotropia; Myopia

Keywords

Intermittent exotropia; Myopia control; DIMS; DOT

Outcome Measures

Primary Outcomes (2)

• Axial length

  Measurement Tool: IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany), a high-resolution swept-source optical coherence tomography (SS-OCT) device for biometric measurement of the eye Measurement Type: Continuous parameters of ocular biometry, mainly including axial length, anterior chamber depth, lens thickness, vitreous depth and other axial dimensional parameters of the eye Unit of Measure: Ocular axial length (AL): Millimeters (mm) Anterior chamber depth (ACD): Millimeters (mm) Lens thickness (LT): Millimeters (mm) Vitreous chamber depth (VCD): Millimeters (mm)

  From enrollment to the end of follow-up at 1 year

• Refractive error with cycloplegia

  Equipment: Cyclopentolate 1%, trial frame, standard trial lens set and logarithmic visual acuity chart for clinical refractive examination Test condition: Completed cycloplegia with cyclopentolate (C) before examination Procedure: The child wears appropriate refractive correction as required. Conduct subjective refraction step by step to determine spherical power, cylindrical power and astigmatic axis. Adjust lenses continuously until the child achieves the clearest and most comfortable vision, then record all refractive parameters and best corrected visual acuity.

  From enrollment to the end of follow-up at 1 year

Secondary Outcomes (3)

• Stereoacuity

  From enrollment to the end of follow-up at 1 year

• Newcastle Control Score (NCS) score

  From enrollment to the end of follow-up at 1 year

• Strabismic deviation

  From enrollment to the end of follow-up at 1 year

Other Outcomes (6)

• Near Point of Convergence

  From enrollment to the end of follow-up at 1 year

• Fusional Vergence Amplitude

  From enrollment to the end of follow-up at 1 year

• Accommodative Convergence / Accommodation (AC/A) Ratio

  From enrollment to the end of follow-up at 1 year

Study Arms (4)

IXT with DIMS

ACTIVE COMPARATOR

Device: DIMS glasses

IXT with DOT

ACTIVE COMPARATOR

Device: DOT glasses

Myopia with DIMS

OTHER

Device: DIMS glasses

Myopia with DOT

OTHER

Device: DOT glasses

Interventions

DIMS glasses DEVICE

Myopia control glasses with peripheral defocus control design.

IXT with DIMS; Myopia with DIMS

DOT glasses DEVICE

Myopia control glasses with diffusion optics technology.

IXT with DOT; Myopia with DOT

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants aged 6 to 12 years (6 ≤ age ≤ 12 years). Written informed consent from legal guardians is mandatory.
• Patients with basic-type intermittent exotropia (IXT) meeting all the following criteria:
• Intermittent or constant exotropia at the distance of 6 meters, and intermittent exotropia or esophoria at the near distance of 33 centimeters;
• Distance exodeviation ≥ 10 prism diopters (PD) measured via the prism and alternate cover test (PACT);
• The difference between near and distance deviation ≤ 10 PD.
• Based on cycloplegic spherical equivalent (SE), the myopic refractive error of both eyes ranges from -6.0 D to -0.5 D.
• The logMAR value of monocular distance best-corrected visual acuity (BCVA) measured by the ETDRS chart is ≤ 0.2, and no amblyopia is present.
• Parents and children are willing to participate in this clinical trial and can complete the entire study protocol.
• Children have healthy eyes without organic ocular diseases.

You may not qualify if:

• Participants who have worn myopia control glasses or received other myopia interventions, including low-concentration atropine and phototherapy instruments, within the past 6 months (excluding DIMS and DOT glasses).
• Those with severe systemic diseases or cognitive impairment that hinders follow-up attendance and clinical examinations.
• \. Subjects with astigmatism of ≥ 2 diopters (D) in either eye after cycloplegia; individuals enrolled in other interventional trials.
• \. Patients with active ocular inflammation in either eye. 6. Those diagnosed with ocular diseases or presenting with clinically significant abnormalities on ophthalmic examinations.
• \. Participants are currently receiving visual function training or other clinical interventions for intermittent exotropia.
• \. Individuals who decline to complete the 1-year follow-up period.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Xiaoning Yu, M.D.

CONTACT

+86 13738170635; yxnzju@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share