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NCT07642934
A Comparative Study of the Efficacy of Myopia Control Lenses With Different Mechanisms on Controlling Myopia Progression in Patients With Intermittent Exotropia
Conditions: Intermittent Exotropia, Myopia
Sex: All
Ages: 6 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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?
Eligibility Criteria
Inclusion Criteria:
1. Participants aged 6 to 12 years (6 ≤ age ≤ 12 years). Written informed consent from legal guardians is mandatory.
2. Patients with basic-type intermittent exotropia (IXT) meeting all the following criteria:
1. Intermittent or constant exotropia at the distance of 6 meters, and intermittent exotropia or esophoria at the near distance of 33 centimeters;
2. Distance exodeviation ≥ 10 prism diopters (PD) measured via the prism and alternate cover test (PACT);
3. The difference between near and distance deviation ≤ 10 PD.
3. Based on cycloplegic spherical equivalent (SE), the myopic refractive error of both eyes ranges from -6.0 D to -0.5 D.
4. The logMAR value of monocular distance best-corrected visual acuity (BCVA) measured by the ETDRS chart is ≤ 0.2, and no amblyopia is present.
5. Parents and children are willing to participate in this clinical trial and can complete the entire study protocol.
6. Children have healthy eyes without organic ocular diseases.
Exclusion Criteria:
1. 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).
2. Those with severe systemic diseases or cognitive impairment that hinders follow-up attendance and clinical examinations.
4\. Subjects with astigmatism of ≥ 2 diopters (D) in either eye after cycloplegia; individuals enrolled in other interventional trials.
5\. Patients with active ocular inflammation in either eye. 6. Those diagnosed with ocular diseases or presenting with clinically significant abnormalities on ophthalmic examinations.
7\. Participants are currently receiving visual function training or other clinical interventions for intermittent exotropia.
8\. Individuals who decline to complete the 1-year follow-up period.
Source: ClinicalTrials.gov (NCT07642934). StuddyBuddy aggregates publicly available trial information.