Peripheral Defocus Profile of Multifocal Minus Contact Lenses

Myopia Clinical Trial

Official title:

Peripheral Defocus Profile of Multifocal Minus Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06335212
• Other study ID #: IRBNET ID 1448963
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: August 5, 2019

Study information

• Verified date: March 2024
• Source: State University of New York College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 5, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Contact Lens
• Myopia
• Refractive Errors

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	State University of New York, College of Optometry	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York College of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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