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CompletedNCT06335212Updated Mar 28, 2024

Peripheral Defocus Profile of Multifocal Minus Contact Lenses

An observational study in Myopia, Refractive Errors and Contact Lens, sponsored by State University of New York College of Optometry. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by State University of New York College of Optometry · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
19
Ages
18 Years to 30 Years
Sex
All
01

Study summary

Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.

Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis.

02

Conditions studied

  • Myopia
  • Refractive Errors
  • Contact Lens

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03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 19 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

State University of New York College of Optometry is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adults between 18 and 30 years of age.

Inclusion criteria

  • 18-30 years of age
  • spherical equivalent (determined with subjective refraction) between -1.00 and -10.00 D in each eye, spherical power between -0.75 and -10.00 D and cylindrical power ≤ 1.50 D
  • monocular best corrected visual acuity 20/25 or better
  • no previous contact lens experience required
  • no history of ocular pathology, binocular vision anomalies, or refractive surgery.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
19 participants (actual)
Patient registry
No

Groups and cohorts

  • One group of subjects were recruited.

    Device: Single vision and multifocal contact lenses

Interventions

  • DeviceSingle vision and multifocal contact lenses

    Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia.

06

What researchers measure

Primary outcomes

  1. refractive power

    Relative pupil limited optical power profile

    Time frame: Relative pupil limited optical power profile was measured once within one month from their first visit when the subjects were uncorrected or wearing contact lenses of various designs

07

Study locations

1 site
  • State University of New York, College of Optometry
    New York, New York 10036, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06335212
Lead sponsor
State University of New York College of Optometry
Responsible party
Xiaoying Zhu, OD, PhD, MD, MS, FAAO (Assistant Clinical Professor, State University of New York College of Optometry) — Principal investigator
First posted
Mar 28, 2024
Start date
Jun 1, 2019
Primary completion
Aug 1, 2019
Completion
Aug 5, 2019
Last update
Mar 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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