Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519490
Recruitment Status : Withdrawn (Lack of interest and support)
First Posted : May 9, 2018
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
SynergEyes, Inc.
Information provided by (Responsible Party):
Thomas A. Aller, OD, Aller, Thomas A., OD

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.


Condition or disease Intervention/treatment Phase
Myopia Myopia, Progressive Device: Hybrid Contact Lens Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Myopia Progression in Children Wearing Near Center and Distance Center Multifocals - a Randomized Controlled Clinical Trial
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Placebo Comparator: Single Vision Hybrid Contact Lens
Subjects will wear the Duette single vision hybrid contact lens.
Device: Hybrid Contact Lens
Hybrid Single Vision or Multifocal Contact Lenses in Near Center and Distance Center Designs

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




Primary Outcome Measures :
  1. Myopia progression rate [ Time Frame: 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. ]
    Change in myopia over time, expressed in terms of an annualized rate, based on cycloplegic spherical equivalent refractive error as measured by autorefraction.

  2. Axial elongation rate [ Time Frame: 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. ]
    Change in axial length over time, expressed in terms of an annualized rate, based on measurement with the Zeiss IOLMaster.


Secondary Outcome Measures :
  1. Subjective myopia progression rate [ Time Frame: 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. ]
    Change in myopia over time, expressed in terms of an annualized rate, based on cycloplegic spherical equivalent refractive error as measured by subjective refraction.

  2. Macular Pigment Optical Density [ Time Frame: Data will be collected at baseline and at 24 months from baseline at study completion. ]
    Macular pigment optical density is measured by the QuantifEye device.

  3. Tear Film Dynamics and Meibomian Gland Health [ Time Frame: Data will be collected at baseline and at 24 months from baseline at study completion. ]
    Lipid layer thickness, blink dynamics and meibomian gland health will be assessed with the Tear Science (Johnson & Johnson) Lipiview device.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Ocular health: any pathology that may alter eye growth (e.g. history of retinal detachment & treatment for the same), and/or may adversely impact contact lens wear (e.g. chronic, poorly controlled allergic conjunctivitis) will be grounds for exclusion;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519490


Locations
Layout table for location information
United States, California
Dr. Thomas Aller Optometrist, Inc.
San Bruno, California, United States, 94066
Sponsors and Collaborators
Thomas A. Aller, OD
SynergEyes, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Thomas A Aller, OD
Publications:

Layout table for additonal information
Responsible Party: Thomas A. Aller, OD, Principal Investigator, Aller, Thomas A., OD
ClinicalTrials.gov Identifier: NCT03519490    
Other Study ID Numbers: SY-001001
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thomas A. Aller, OD, Aller, Thomas A., OD:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Myopia, Degenerative
Refractive Errors
Eye Diseases