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OpenTrials
Completed

NCT Number: NCT03479827

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14627, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monofocal Contact Lens

Device

A monofocal contact lens will be used for this measurement.

Bifocal Contact Lens

Device

A bifocal contact lens will be used for this measurement.

Primary outcomes

  1. Mean Wavefront aberrations

    Time frame: less than 2 hours

    The scanning wavefront sensor will be used to collect data. Mean Wavefront aberrations for each trail will be analyzed.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2018
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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