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

NCT06863675 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SingaporeNEC_HALTXT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Myopia; Strabismus

Keywords

Myopia; Strabismus; HALT; Stellest; Myopia Control

Outcome Measures

Primary Outcomes (1)

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

  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).

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

HALT lenses for children with strabismus

ACTIVE COMPARATOR

Stellest lenses for children with strabismus

Device: HAL lenses for children with strabismus

SVL for children with strabismus

PLACEBO COMPARATOR

SVL for children with strabismus

Device: SVL for children with strabismus

Interventions

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.

HALT lenses for children with strabismus

SVL for children with strabismus DEVICE

SVL for children with strabismus

Also known as: Single Vision Lenses

SVL for children with strabismus

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 (?)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

Myopia; Strabismus

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Bryan Sim BSX Sim, MD FRCOphth (UK)

CONTACT

+6562277255; bryansimxr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Randomised controlled trial (RCT)

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: June 2025 to June 2028
• Access Criteria: PI Co-PI Study members

Locations

SG (1)