Measuring the Peripheral Optical Quality of The Eye

Nearsightedness Clinical Trial

Official title:

Measuring the Peripheral Optical Quality of The Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479827
• Other study ID #: 71201
• Status: Completed
• Start date: August 31, 2018
• Est. completion date: November 29, 2020

Study information

• Verified date: August 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 29, 2020
• Est. primary completion date: November 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Nearsightedness

Intervention

Device:
• Monofocal Contact Lens
A monofocal contact lens will be used for this measurement.
• Bifocal Contact Lens
A bifocal contact lens will be used for this measurement.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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