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Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01230164
First received: October 27, 2010
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye.

The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology), Zywave (Bausch & Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc). In particular, the investigators propose to focus on the ability of these devices to display the higher order visual aberrations and to compare the quality of outputs from these 4 devices in normal healthy subjects.


Condition
Normal Individuals With Visual Aberrations

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Enrollment: 21
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal subjects over the age of 18 with visual abberations.

Criteria

Inclusion Criteria:

  • male or female, at least 18 years of age
  • no ocular abnormality other than refractive error
  • patient in generally good & stable overall health
  • has not worn contact lenses (hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 3 days) prior to the study exam
  • corneal topography must be normal, as judged by the investigator
  • topical anesthesia and mydriatics must be tolerated
  • patient must be able to fixate steadily
  • ability to understand and provide informed consent to participate in this study

Exclusion Criteria:

  • history of ocular surgery
  • history of ocular trauma, infection, disease, or abnormality other than refractive error
  • myopia or hyperopia > 7.0 D, astigmatism >3.0 D
  • uncorrectable visual acuity below 20/20
  • abnormal corneal topography pattern including, but not limited to keratoconus, forme fruste keratoconus, or corneal warpage
  • pupil sizes below 6.0 mm under mydriasis
  • iris problems including, but not limited to, coloboma and previous iris surgery
  • ocular media problems, corneal, lens and/or vitreous opacities including, but not limited to cataract
  • ocular movement abnormalities including, but not limited to, strabismus or nystagmus
  • phenol red thread test (Zone Quick-Menicon Ltd) less than 9 mm/15 seconds
  • pregnancy and lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230164

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Roberto Pineda, MD Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01230164     History of Changes
Other Study ID Numbers: 09-03-016
Study First Received: October 27, 2010
Last Updated: December 19, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013