NCT03519490: ADPADP

Can Distance Center and Near Center Multifocal Contact Lenses Control Myopia Progression in Children?

Withdrawn NA Last updated 5 July 2019

What this trial tests

NA trial testing Hybrid Contact Lens in Myopia. Withdrawn.

Timeline

1 June 2018

Primary endpoint
31 July 2020

31 August 2020

Quick facts

Lead sponsor	Thomas A. Aller, OD
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 June 2018
Primary completion	31 July 2020
Estimated completion	31 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Hybrid Contact Lens

Conditions studied

• Myopia — all drugs for Myopia →
• Myopia, Progressive — all drugs for Myopia, Progressive →

Sponsor

Thomas A. Aller, OD

Who can join

Adults 7 to 14, any sex, with Myopia or Myopia, Progressive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Myopia has been increasing in prevalence and severity throughout the world over the last 30 years. Increasing levels of myopia are associated with increased frequency and severity of various ocular pathologies. Slowing myopia progression may help to reduce the future risks of these ocular pathologies.

Conventional spectacles and contact lenses correct myopia by moving the central focus of the eye from in front of the retina to on the retina centrally. To varying degrees, these lenses allow the light to focus behind the retina, at varying peripheral retinal locations. These findings have led to efforts to design spectacle and contact lenses which correct peripheral hyperopic defocus, to reduce myopia progression.

The consensus theory for how both multifocal contact lenses (MFCLs) and orthokeratology can control myopia progression is that they reduce, eliminate, or reverse relative peripheral hyperopic defocus. Existing published studies on the use of multifocal contact lenses to control myopia in humans have utilized lenses with the distance correction in the center with peripheral plus power to correct the peripheral blur.

It is possible that one of the mechanisms responsible for myopia progression control with MFCLs is that when the eye is exposed to an image focused on the retina and simultaneously an image anterior to the retina, that this will suppress axial elongation and myopia progression. This mechanism would not be dependent on whether the anterior image is located in the central area of the retina or the peripheral area of the retina. While there are no published human studies demonstrating the effectiveness of near center MFCLs, this author has presented retrospective data showing no differences in myopia progression between near center and distance center MFCLs.

Synergeyes, Inc.'s Duette contact lenses are hybrids of rigid gas permeable (RGP) with a silicon hydrogel peripheral portion or "skirt." They now make their MFCLs in both distance center (DC) and near center (NC) designs.

This study will analyze the myopia progression of children after being randomly assigned to wear Duette MFCLs or Duette standard single vision contact lenses over a span of two years. Subjects assigned to the MFCL group will wear a DC lens on one eye and a NC lens on the other and will reverse this lens assignment every six months. Refractive changes will be measured by cycloplegic autorefraction and axial lengths will be measured with a laser interference biometer (Zeiss IOLMaster) at six-month intervals.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to slow progression of myopia in children.
   Walline JJ, Lindsley KB, Vedula SS, Cotter SA, et al · · 2020 · cited 128× · PMID 31930781 · DOI 10.1002/14651858.cd004916.pub4
2. Interventions for myopia control in children: a living systematic review and network meta-analysis.
   Lawrenson JG, Shah R, Huntjens B, Downie LE, et al · · 2023 · cited 117× · PMID 36809645 · DOI 10.1002/14651858.cd014758.pub2