Peripheral Defocus Profile of Multifocal Minus Contact Lenses

NCT06335212 | Completed FDA Device

• 1 other identifier: IRBNET ID 1448963
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; Refractive Errors; Contact Lens

Outcome Measures

Primary Outcomes (1)

• refractive power

  Relative pupil limited optical power profile

  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

Study Arms (1)

One group of subjects were recruited.

Device: Single vision and multifocal contact lenses

Interventions

Single vision and multifocal contact lenses DEVICE

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.

One group of subjects were recruited.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults between 18 and 30 years of age.

You may qualify if:

• 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.

Sponsors & Collaborators

• State University of New York College of Optometry: lead

Study Sites (1)

State University of New York, College of Optometry

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: March 28, 2024
• Study Start: June 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 5, 2019
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

US (1)