Myopia, Strabismus
Conditions
Keywords
Myopia, Strabismus, HALT, Stellest, Myopia Control
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
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.
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
Sponsors
Singapore National Eye Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomised controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of HAL lenses in childhood myopia control in children with strabismus and nystagmus | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect on strabismus (subjectively and functionally) over first vs second 6m | 2 years | Primary measure: Change in squint size and control as measured by Newcastle control score (NCS) |
Countries
Singapore
Contacts
Primary ContactBryan Sim BSX Sim, MD FRCOphth (UK)
Outcome results
None listed