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Not yet recruitingNCT06863675HALT XTUpdated Mar 7, 2025

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

A Phase 3 interventional study of HAL lenses for children with strabismus and SVL for children with strabismus in Myopia and Strabismus, sponsored by Singapore National Eye Centre. Not yet recruiting at 1 site in Singapore. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Singapore National Eye Centre · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Myopia by Singapore National Eye Centre — 5 open to participants now, 6 under way, 2 of them phase 3. Myopia · Singapore National Eye Centre.

Planned enrollment
8th of 11
40 · median 70
Started
2025
with 2 others
Phase 3
2 of 16
1 open now
Registered
14th of 16
by date

Among the 16 studies in Myopia by Singapore National Eye Centre, this one is the 8th largest by planned enrollment of the 11 interventional ones that give a count, is one of 3 that started in 2025, is one of 2 in phase 3, and was the 14th registered.

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

5 of the 16 studies in Myopia by Singapore National Eye Centre are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 5 Years to 12 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Myopia by Singapore National Eye Centre, or all of them as a file.
02

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

Read the detailed 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.

03

Conditions studied

  • Myopia
  • Strabismus

Keywords

  • Myopia
  • Strabismus
  • HALT
  • Stellest
  • Myopia Control
04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    HALT lenses for children with strabismus

    Stellest lenses for children with strabismus

    Device: HAL lenses for children with strabismus

  • Placebo comparator
    SVL for children with strabismus

    SVL for children with strabismus

    Device: SVL for children with strabismus

Interventions

  • DeviceHAL lenses for children with strabismus

    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.

  • DeviceSVL for children with strabismus

    SVL for children with strabismus

    Also known as: Single Vision Lenses

06

What researchers measure

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).

    Time frame: 2 years

Secondary outcomes

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

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

    Time frame: 2 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Inclusion exclusion criteria Age Myopia progression Axial length

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: June 2025 to June 2028

Access criteria: PI Co-PI Study members

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Jun 2028, 36 months later.

Of 25 phase 3 interventional studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2025
First posted
Mar 7, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2030
Last update
Mar 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06863675
Lead sponsor
Singapore National Eye Centre
Responsible party
Bryan Sim XR (Consultant, Singapore National Eye Centre) — Principal investigator
First posted
Mar 7, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Mar 7, 2025

Study contacts

Bryan Sim BSX Sim, MD FRCOphth (UK)
Contact
bryansimxr@hotmail.com
+6562277255 ext. 62277255

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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