Highly Aspherical Lenslet (HAL) and Binocular Vision (BV) Disorders [HALT X(T) Study]

Last updated: March 3, 2025
Sponsor: Singapore National Eye Centre
Overall Status: Active - Not Recruiting

Phase

3

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

HAL lenses for children with strabismus

SVL for children with strabismus

Clinical Study ID

NCT06863675
SingaporeNEC_HALTXT
  • Ages 5-12
  • All Genders

Study Summary

Assess the effect and changes of eye misalignment (strabismus) with myopia control glasses Assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 5-12 years old Myopia of between -1D and -6D in at least 1 eye Progression of at least 0.5D within the last year Astigmatism less than 2.5D Exotropia Exophoria: horizontal deviation <40PD Esotropia (good control), Esophoria: horizontal deviation <40PD Any vertical strabismus: Vertical deviation <10 PD Intermittent exotropia (good, moderate, poor) Horizontal deviation ≥15 PD, vertical deviation ≤5 PD (?)

Exclusion

Exclusion Criteria:

VA poorer than logMAR 0.2 (6/9.5) in either eye Any other ocular condition (e.g. lens opacity, glaucoma) other than myopia, strabismus or nystagmus) Any medical/neurological condition which would interfere with subjects ability to co-operate with tests and attend follow-up appointments.

Plans of surgery for strabismus or nystagmus in the next year Constant XT). Past use of any other from of myopia control treatment (eg. atropine or myopia control glasses or contact lenses) within the last year.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: HAL lenses for children with strabismus
Phase: 3
Study Start date:
June 01, 2025
Estimated Completion Date:
June 30, 2030

Study Description

Studies have been done to show that spectacles, atropine eye drops, and outdoor activities have some efficacy in slowing myopia progression in children, however most of such studies exclude children with significant eye conditions such as strabismus or nystagmus to isolate the effects of myopia control treatment. In this study, we would like to investigate whether these specialized glasses can effectively slow down the progression of myopia in children with strabismus. Since strabismus can affect visual development, this study would also be able to assess the effect and changes of eye misalignment (strabismus) with myopia control glasses. The study also aims to assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children.

Connect with a study center

  • Singapore National Eye Centre

    Singapore,
    Singapore

    Site Not Available

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