NCT03479827

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2020

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

February 27, 2018

Last Update Submit

August 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 LensDevice: Bifocal Contact Lens

Interventions

A monofocal contact lens will be used for this measurement.

Experimental

A bifocal contact lens will be used for this measurement.

Experimental

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with no ocular pathology and uses contact lenses.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Geunyoung Yoon, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 27, 2018

Study Start

August 31, 2018

Primary Completion

November 29, 2020

Study Completion

November 29, 2020

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations