- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230164
Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
Investigators
- Principal Investigator: Roberto Pineda, MD, Massachusetts Eye and Ear Infirmary
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09-03-016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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