NCT04334369

Brief Summary

The purpose of the study is to determine the effect of Natural View Multifocal lenses, a soft multifocal lens, on retardation of myopia in an optometric student population. Close up work (i.e. reading, computer work, etc.) is thought to play a factor in the progression of myopia in young adults. The progression should be slowed if not stopped through the use of peripheral defocus lenses (Natural View Multifocal) to change the optics of the eye in order to focus the image on the peripheral retina as opposed to behind it.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2022

Completed
Last Updated

July 7, 2022

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

March 26, 2020

Last Update Submit

July 3, 2022

Conditions

Myopia, Progressive

Keywords

Multifocal contact lensesMyopia progressionAxial length

Outcome Measures

Primary Outcomes (2)

  • Contact Lenses and Myopia Progression

    Changes in axial length in millimeters

    3 years

  • Contact Lenses and Myopia Progression

    Progression of Myopia in Diopters

    3years

Study Arms (2)

Single Vision Contact Lenses

SHAM COMPARATOR
Device: Proclear Single Vision Contact Lenses manufactured by CooperVision

Multifocal Contact Lenses

EXPERIMENTAL
Device: Proclear Multifocal Contact Lenses manufactured by CooperVision

Interventions

Proclear Single Vision Contact Lenses manufactured by CooperVisionDEVICE

FDA approved single vision contact lenses.

Single Vision Contact Lenses
Proclear Multifocal Contact Lenses manufactured by CooperVisionDEVICE

FDA Approved Multifocal Contact Lenses

Multifocal Contact Lenses

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be first or second year Optometric students at RSO
  • Be non-presbyopic
  • Have at least -0.50 Diopters or more of myopia in one or both eyes
  • Have no systemic health issues
  • Have no previous history of Orthokeratology
  • Have no gas permeable contact use in the last 6 months
  • Not be enrolled in any other eye study
  • Be able to have a cycloplegic refraction
  • New and existing contact lens wearers

You may not qualify if:

  • Progressive retinal or corneal disorder as well as any of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bowden Eye Care & Health Center

San Antonio, Texas, 78203, United States

Location

Related Publications (13)

  • D. Lee, Y. Pang, R. Patel, M. Patel. A study of myopia progression in young adults Investigate Ophthalmology and Vision Science: An ARVO Journal. 2008;49(13)

    BACKGROUND

  • Fedtke C, Ehrmann K, Holden BA. A review of peripheral refraction techniques. Optom Vis Sci. 2009 May;86(5):429-46. doi: 10.1097/OPX.0b013e31819fa727.

    PMID: 19342977BACKGROUND

  • 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: 27495880BACKGROUND

  • Multifocal contact lens effective at treating myopia in kids. American Optometric Association. April 25, 2016. Available from: https://www.aoa.org/news/clinical-eye-care/multifocal-contact-lens-effective-at-treating-myopia-in-kids.

    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: 24061152BACKGROUND

  • Li SM, Ji YZ, Wu SS, Zhan SY, Wang B, Liu LR, Li SY, Wang NL, Wang JJ. Multifocal versus single vision lenses intervention to slow progression of myopia in school-age children: a meta-analysis. Surv Ophthalmol. 2011 Sep-Oct;56(5):451-60. doi: 10.1016/j.survophthal.2011.06.002. Epub 2011 Aug 2.

    PMID: 21813146BACKGROUND

  • Fan DS, Lam DS, Lam RF, Lau JT, Chong KS, Cheung EY, Lai RY, Chew SJ. Prevalence, incidence, and progression of myopia of school children in Hong Kong. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1071-5. doi: 10.1167/iovs.03-1151.

    PMID: 15037570BACKGROUND

  • Shimizu N, Nomura H, Ando F, Niino N, Miyake Y, Shimokata H. Refractive errors and factors associated with myopia in an adult Japanese population. Jpn J Ophthalmol. 2003 Jan-Feb;47(1):6-12. doi: 10.1016/s0021-5155(02)00620-2.

    PMID: 12586171BACKGROUND

  • Vitale S, Sperduto RD, Ferris FL 3rd. Increased prevalence of myopia in the United States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009 Dec;127(12):1632-9. doi: 10.1001/archophthalmol.2009.303.

    PMID: 20008719BACKGROUND

  • Resnikoff S, Pascolini D, Mariotti SP, Pokharel GP. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bull World Health Organ. 2008 Jan;86(1):63-70. doi: 10.2471/blt.07.041210.

    PMID: 18235892BACKGROUND

  • Wu PC, Tsai CL, Wu HL, Yang YH, Kuo HK. Outdoor activity during class recess reduces myopia onset and progression in school children. Ophthalmology. 2013 May;120(5):1080-5. doi: 10.1016/j.ophtha.2012.11.009. Epub 2013 Feb 22.

    PMID: 23462271BACKGROUND

  • Si JK, Tang K, Bi HS, Guo DD, Guo JG, Wang XR. Orthokeratology for myopia control: a meta-analysis. Optom Vis Sci. 2015 Mar;92(3):252-7. doi: 10.1097/OPX.0000000000000505.

    PMID: 25599338BACKGROUND

  • Cooper J, O'Connor B, Watanabe R, Fuerst R, Berger S, Eisenberg N, Dillehay SM. Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens. Eye Contact Lens. 2018 Sep;44(5):e16-e24. doi: 10.1097/ICL.0000000000000440.

    PMID: 29053555BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Officials

  • Mervyn Bloom, OD

    University of the Incarnate Word

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROFESSOR AND ASSISTANT DEAN

Study Record Dates

First Submitted

March 26, 2020

First Posted

April 6, 2020

Study Start

December 12, 2018

Primary Completion

July 3, 2022

Study Completion

July 3, 2022

Last Updated

July 7, 2022

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)