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NCT Number: NCT06863675

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

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

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Singapore National Eye Centre

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

HAL lenses for children with strabismus

Device

It has been shown that peripheral segmented defocus spectacles can slow myopia progression. The Essilor® Stellest™ lens has been designed with an exclusive and pioneering technology called HALT (Highly Aspherical Lenslet Target). The HALT technology is made of a constellation of 1,021 invisible lenslets. This constellation creates a signal in front of the retina that acts as a shield against eye elongation and, therefore, myopia progression. Studies suggest that children are tolerable against these glasses, and the lenses can slow down myopia progression by 67% on average, compared to single vision lenses, when worn 12 hours a day. It can be considered as one of the best available myopia control spectacle lens designs, being superior to progressive addition and bifocal lenses.

SVL for children with strabismus

Device

SVL for children with strabismus

Other names: Single Vision Lenses

Primary outcomes

  1. To assess the efficacy of HAL lenses in childhood myopia control in children with strabismus and nystagmus

    Time frame: 2 years

    a. Efficacy in each eye - i. Primary outcome: change in AL in first vs second 6m ii. Secondary outcome: change in cycloplegic SE & OCT choroidal thickness b. Alternative analysis: Difference between preferred/non-preferred eye, better-worse squint (size and control at baseline and 6m).

Secondary outcomes

  1. To assess the effect on strabismus (subjectively and functionally) over first vs second 6m

    Time frame: 2 years

    Primary measure: Change in squint size and control as measured by Newcastle control score (NCS)

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan Sim BSX Sim, MD FRCOphth (UK)

CONTACT

[email protected]

+6562277255 ext. 62277255

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Registry information

Acronym: HALT XT

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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