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

NCT03519490 | Withdrawn FDA Device

• 1 other identifier: SY-001001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Myopia, Progressive

Keywords

Myopia; Myopia Control; Bifocal Contact Lenses; Multifocal Contact Lenses; Hybrid Contact Lenses; Randomized Controlled Clinical Trial; Distance Center Multifocal Contact Lens; Near Center Multifocal Contact Lens

Outcome Measures

Primary Outcomes (2)

• Myopia progression rate

  Change in myopia over time, expressed in terms of an annualized rate, based on cycloplegic spherical equivalent refractive error as measured by autorefraction.

  Data will be collected at baseline, that is to say at the beginning of the 24 month study, and also at six months after baseline, at 12 months, at 18 months and at study completion or 24 months.

• Axial elongation rate

  Change in axial length over time, expressed in terms of an annualized rate, based on measurement with the Zeiss IOLMaster.

  Data will be collected at baseline, that is to say at the beginning of the 24 month study, and also at six months after baseline, at 12 months, at 18 months and at study completion or 24 months.

Secondary Outcomes (3)

• Subjective myopia progression rate

  Data will be collected at baseline, that is to say at the beginning of the 24 month study, and also at six months after baseline, at 12 months, at 18 months and at study completion or 24 months.

• Macular Pigment Optical Density

  Data will be collected at baseline and at 24 months from baseline at study completion.

• Tear Film Dynamics and Meibomian Gland Health

  Data will be collected at baseline and at 24 months from baseline at study completion.

Study Arms (2)

Single Vision Hybrid Contact Lens

PLACEBO COMPARATOR

Subjects will wear the Duette single vision hybrid contact lens.

Device: Hybrid Contact Lens

Multifocal Hybrid Contact Lens

EXPERIMENTAL

Subjects will wear the Duette hybrid multifocal contact lens with the near center design in one eye and the distance center design in the other eye with a crossover at every six months.

Device: Hybrid Contact Lens

Interventions

Hybrid Contact Lens DEVICE

Hybrid Single Vision or Multifocal Contact Lenses in Near Center and Distance Center Designs

Multifocal Hybrid Contact Lens; Single Vision Hybrid Contact Lens

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Myopia: ≥ 0.5 D in least myopic meridian, \< 12.0 D in most myopic meridian);
• Anisometropia (interocular difference in refractive error) ≤ 2D
• Astigmatism: ≤ 3D
• Myopia progression ≥ 0.5D in at least one eye based on available clinical records or based on habitual spectacle prescription
• Visual acuity: best corrected acuity of 20/20 or better in each eye
• Capable of proper handling, insertion and removal of hybrid contact lenses

You may not qualify if:

• Strabismus, amblyopia
• Systemic disease that may affect vision, vision development or contact lens wear
• Chronic use of medications that may affect immunity, such as oral or topical corticosteroids
• rigid or hybrid contact lens wear within the preceding 3 months;
• prior ocular surgery,
• nursing or pregnant mothers
• participants who cannot commit to the 24 month study period or who have a high likelihood of leaving the area within the 24 month study period

Sponsors & Collaborators

• Thomas A. Aller, OD: lead
• SynergEyes, Inc.: collaborator

Study Sites (1)

Dr. Thomas Aller Optometrist, Inc.

San Bruno, California, 94066, United States

Location

Related Publications (31)

• Aller T, Wildsoet C. Optical control of myopia has come of age: or has it? Optom Vis Sci. 2013 May;90(5):e135-7. doi: 10.1097/OPX.0b013e31828b47cf.

  PMID: 23528448 BACKGROUND

• Aller TA, Wildsoet C. Bifocal soft contact lenses as a possible myopia control treatment: a case report involving identical twins. Clin Exp Optom. 2008 Jul;91(4):394-9. doi: 10.1111/j.1444-0938.2007.00230.x.

  PMID: 18601670 BACKGROUND

• Aller TA. Clinical management of progressive myopia. Eye (Lond). 2014 Feb;28(2):147-53. doi: 10.1038/eye.2013.259. Epub 2013 Dec 20.

  PMID: 24357844 BACKGROUND

• Aller TA, Liu M, Wildsoet CF. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial. Optom Vis Sci. 2016 Apr;93(4):344-52. doi: 10.1097/OPX.0000000000000808.

  PMID: 26784710 BACKGROUND

• Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.

  PMID: 21276616 BACKGROUND

• Benavente-Perez A, Nour A, Troilo D. The effect of simultaneous negative and positive defocus on eye growth and development of refractive state in marmosets. Invest Ophthalmol Vis Sci. 2012 Sep 21;53(10):6479-87. doi: 10.1167/iovs.12-9822.

  PMID: 22918633 BACKGROUND

• Arumugam B, Hung LF, To CH, Holden B, Smith EL 3rd. The effects of simultaneous dual focus lenses on refractive development in infant monkeys. Invest Ophthalmol Vis Sci. 2014 Oct 16;55(11):7423-32. doi: 10.1167/iovs.14-14250.

  PMID: 25324283 BACKGROUND

• Benavente-Perez A, Nour A, Troilo D. Axial eye growth and refractive error development can be modified by exposing the peripheral retina to relative myopic or hyperopic defocus. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6765-73. doi: 10.1167/iovs.14-14524.

  PMID: 25190657 BACKGROUND

• Berntsen DA, Kramer CE. Peripheral defocus with spherical and multifocal soft contact lenses. Optom Vis Sci. 2013 Nov;90(11):1215-24. doi: 10.1097/OPX.0000000000000066.

  PMID: 24076542 BACKGROUND

• Chakraborty R, Read SA, Collins MJ. Hyperopic defocus and diurnal changes in human choroid and axial length. Optom Vis Sci. 2013 Nov;90(11):1187-98. doi: 10.1097/OPX.0000000000000035.

  PMID: 24061153 BACKGROUND

• Cui Y, Li L, Wu Q, Zhao J, Chu H, Yu G, Wei W. Myopia correction in children: a meta-analysis. Clin Invest Med. 2017 Jun 26;40(3):E117-E126. doi: 10.25011/cim.v40i3.28391.

  PMID: 28653613 BACKGROUND

• Fedtke C, Ehrmann K, Thomas V, Bakaraju RC. Peripheral Refraction and Aberration Profiles with Multifocal Lenses. Optom Vis Sci. 2017 Sep;94(9):876-885. doi: 10.1097/OPX.0000000000001112.

  PMID: 28816867 BACKGROUND

• Holden B, Sankaridurg P, Smith E, Aller T, Jong M, He M. Myopia, an underrated global challenge to vision: where the current data takes us on myopia control. Eye (Lond). 2014 Feb;28(2):142-6. doi: 10.1038/eye.2013.256. Epub 2013 Dec 20.

  PMID: 24357836 BACKGROUND

• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  PMID: 26875007 BACKGROUND

• Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.

  PMID: 26826749 BACKGROUND

• Jong M, Sankaridurg P, Li W, Resnikoff S, Naidoo K, He M. Reduced vision in highly myopic eyes without ocular pathology: the ZOC-BHVI high myopia study. Clin Exp Optom. 2018 Jan;101(1):77-83. doi: 10.1111/cxo.12563. Epub 2017 Jul 11.

  PMID: 28696042 BACKGROUND

• Kang P, McAlinden C, Wildsoet CF. Effects of multifocal soft contact lenses used to slow myopia progression on quality of vision in young adults. Acta Ophthalmol. 2017 Feb;95(1):e43-e53. doi: 10.1111/aos.13173. Epub 2016 Aug 6.

  PMID: 27495880 BACKGROUND

• Kim E, Bakaraju RC, Ehrmann K. Power Profiles of Commercial Multifocal Soft Contact Lenses. Optom Vis Sci. 2017 Feb;94(2):183-196. doi: 10.1097/OPX.0000000000000998.

  PMID: 27748699 BACKGROUND

• Li SM, Kang MT, Wu SS, Meng B, Sun YY, Wei SF, Liu L, Peng X, Chen Z, Zhang F, Wang N. Studies using concentric ring bifocal and peripheral add multifocal contact lenses to slow myopia progression in school-aged children: a meta-analysis. Ophthalmic Physiol Opt. 2017 Jan;37(1):51-59. doi: 10.1111/opo.12332. Epub 2016 Nov 23.

  PMID: 27880992 BACKGROUND

• Liu Y, Wildsoet C. The effect of two-zone concentric bifocal spectacle lenses on refractive error development and eye growth in young chicks. Invest Ophthalmol Vis Sci. 2011 Feb 22;52(2):1078-86. doi: 10.1167/iovs.10-5716. Print 2011 Feb.

  PMID: 20861487 BACKGROUND

• Liu Y, Wildsoet C. The effective add inherent in 2-zone negative lenses inhibits eye growth in myopic young chicks. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5085-93. doi: 10.1167/iovs.12-9628.

  PMID: 22761258 BACKGROUND

• Lopes-Ferreira D, Fernandes P, Queiros A, Gonzalez-Meijome JM. Combined Effect of Ocular and Multifocal Contact Lens Induced Aberrations on Visual Performance: Center-Distance Versus Center-Near Design. Eye Contact Lens. 2018 Sep;44 Suppl 1:S131-S137. doi: 10.1097/ICL.0000000000000355.

  PMID: 28060146 BACKGROUND

• McFadden SA, Tse DY, Bowrey HE, Leotta AJ, Lam CS, Wildsoet CF, To CH. Integration of defocus by dual power Fresnel lenses inhibits myopia in the mammalian eye. Invest Ophthalmol Vis Sci. 2014 Feb 14;55(2):908-17. doi: 10.1167/iovs.13-11724.

  PMID: 24398103 BACKGROUND

• Sankaridurg P. Contact lenses to slow progression of myopia. Clin Exp Optom. 2017 Sep;100(5):432-437. doi: 10.1111/cxo.12584. Epub 2017 Jul 28.

  PMID: 28752898 BACKGROUND

• Smith EL 3rd, Kee CS, Ramamirtham R, Qiao-Grider Y, Hung LF. Peripheral vision can influence eye growth and refractive development in infant monkeys. Invest Ophthalmol Vis Sci. 2005 Nov;46(11):3965-72. doi: 10.1167/iovs.05-0445.

  PMID: 16249469 BACKGROUND

• Smith EL 3rd, Hung LF, Huang J, Arumugam B. Effects of local myopic defocus on refractive development in monkeys. Optom Vis Sci. 2013 Nov;90(11):1176-86. doi: 10.1097/OPX.0000000000000038.

  PMID: 24061154 BACKGROUND

• Tarrant J, Severson H, Wildsoet CF. Accommodation in emmetropic and myopic young adults wearing bifocal soft contact lenses. Ophthalmic Physiol Opt. 2008 Jan;28(1):62-72. doi: 10.1111/j.1475-1313.2007.00529.x.

  PMID: 18201337 BACKGROUND

• Tse DY, To CH. Graded competing regional myopic and hyperopic defocus produce summated emmetropization set points in chick. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8056-62. doi: 10.1167/iovs.10-5207.

  PMID: 21911586 BACKGROUND

• Walline JJ, Lindsley K, Vedula SS, Cotter SA, Mutti DO, Twelker JD. Interventions to slow progression of myopia in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD004916. doi: 10.1002/14651858.CD004916.pub3.

  PMID: 22161388 BACKGROUND

• Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia control. Optom Vis Sci. 2013 Nov;90(11):1207-14. doi: 10.1097/OPX.0000000000000036.

  PMID: 24061152 BACKGROUND

• Wallman J, Wildsoet C, Xu A, Gottlieb MD, Nickla DL, Marran L, Krebs W, Christensen AM. Moving the retina: choroidal modulation of refractive state. Vision Res. 1995 Jan;35(1):37-50. doi: 10.1016/0042-6989(94)e0049-q.

  PMID: 7839608 BACKGROUND

MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Thomas A Aller, OD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All lenses are identical in size, color and fitting characteristics. Lenses are supplied from the manufacturer with labels with full parameter information. This information will be removed or masked on the vials prior to being delivered to the office by the study coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Using a covariate adaptive randomization strategy, participants will be assigned to wear either multifocal or single vision Duette hybrid contact lenses for a period of two years. Additionally, subjects wearing the MFCLs will wear distance center in one eye and near center in the other eye, switching every six months.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 9, 2018
• Study Start: June 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: August 31, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (1)