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

October 27, 2010
December 19, 2011
August 2010
July 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01230164 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations
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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Normal subjects over the age of 18 with visual abberations.

Normal Individuals With Visual Aberrations
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01230164
09-03-016
No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Principal Investigator: Roberto Pineda, MD Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP