Measuring the Peripheral Optical Quality of The Eye

NCT ID: NCT03479827

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nearsightedness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Monofocal Contact Lens

Intervention Type DEVICE

A monofocal contact lens will be used for this measurement.

Bifocal Contact Lens

Intervention Type DEVICE

A bifocal contact lens will be used for this measurement.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Monofocal Contact Lens

A monofocal contact lens will be used for this measurement.

Intervention Type DEVICE

Bifocal Contact Lens

A bifocal contact lens will be used for this measurement.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Geunyoung Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Geunyoung Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Rochester

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

71201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Changes in Eye Shape With Myopia Management Interventions
NCT06450132 ACTIVE_NOT_RECRUITING PHASE4