Measuring the Peripheral Optical Quality of The Eye

The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality.

Study Overview

• Status: Completed
• Conditions: Nearsightedness
• Intervention / Treatment: Device: Monofocal Contact Lens; Device: Bifocal Contact Lens

Detailed Description

The goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. The goal will be accomplished by performing optical measurements using Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with no ocular pathology and uses contact lenses.

Description

Inclusion Criteria

A person will be included in the study if he/she:

• Is 18 years or older and has full legal capacity to volunteer.
• Has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration;
• Has no active ocular disease or allergic conjunctivitis;
• Is not using any topical ocular medications;
• Is willing and able to follow instructions;
• Has voluntarily agreed to participate in the study by signing the statement of informed consent.

Exclusion Criteria

A person will be excluded from the study if he/she:

• Is under the age of 18 or over the age of 60 yrs.
• Correctable with high contrast logMAR acuity (EDTRS) testing to 20/20 or better;
• Pregnant at the time of enrolment in the study;
• Unable to handle, insert, remove or care for the study lenses;
• Considered by the Investigator to not be a suitable candidate for participation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Subjects will undergo three Wavefront measurements, once with no contact lens, once with a monofocal contact lens and once with a bifocal contact lens.	Device: Monofocal Contact Lens; A monofocal contact lens will be used for this measurement.; Device: Bifocal Contact Lens; A bifocal contact lens will be used for this measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Wavefront aberrations	The scanning wavefront sensor will be used to collect data. Mean Wavefront aberrations for each trail will be analyzed.	less than 2 hours

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Geunyoung Yoon, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): November 29, 2020
• Study Completion (Actual): November 29, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 71201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes