Peripheral Defocus Profile of Multifocal Minus Contact Lenses

NCT ID: NCT06335212

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-08-05

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

One group of subjects were recruited.

Single vision and multifocal contact lenses

Intervention Type: 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.

Interventions

Single 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.

Intervention Type: DEVICE

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Xiaoying Zhu, OD, PhD, MD, MS, FAAO

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State University of New York, College of Optometry

New York, New York, United States

Countries

United States

Other Identifiers

IRBNET ID 1448963

Identifier Type: -

Identifier Source: org_study_id