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

ConditionsMyopia Strabismus

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age5-12

SponsorSingapore National Eye Centre

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: HALT lenses for children with strabismusActive comparator 1 intervention

Group B: SVL for children with strabismusPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singapore National Eye Centre

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: