Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01663597
First received: August 9, 2012
Last updated: August 28, 2013
Last verified: August 2013

August 9, 2012
August 28, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
Axial eye length [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01663597 on ClinicalTrials.gov Archive Site
  • Refractive error [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Corneal radius [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Pupil diameter [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Anterior chamber depth [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Anterior corneal topography [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Corneal thickness map [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

Aberrations play a significant role in the visual process and can be divided in lower-order and higher-order aberrations. The former can be measured using the commercially available IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity. Higher-order aberrations do not significantly influence visual acuity but affect the quality of vision and can cause halos, double vision, and night vision disturbances.

Background Cataract surgery has become a routine procedure in the developed countries. During this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However, these lenses do not account for individual optical biometry data or aberrations. Therefore, it is important to provide data for ametropic and emmetropic eyes as this information might improve future intraocular lens design and lead to individually adapted lenses for yielding optimal visual acuity and quality results.

The aim of the present study is to clarify the correlation between refractive errors/axial eye length and spherical aberrations of the cornea.

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

The participants will be selected by the Department of Clinical Pharmacology

  • Refractive Errors
  • Axial Length, Eye
  • Corneal Wavefront Aberration
Not Provided
  • Cohort 1
    40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters
  • Cohort 2
    40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter
  • Cohort 3
    40 subjects with emmetropia, -1 diopter to +1 diopter
  • Cohort 4
    40 subjects with hyperopia, +1.01 diopter and more
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and women aged between 40 and 60 years
  • normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • normal ophthalmic findings unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

  • presence of any corneal or retinal disease
  • Dry eye syndrome
  • high astigmatism (>1 diopter)
  • history of refractive surgery
  • abuse of alcoholic beverages
  • participation in a clinical trial in the 3 weeks preceding the study
  • symptoms of a clinically relevant illness in the 3 weeks before the study day
  • pregnancy
Both
40 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01663597
OPHTH-240512
Not Provided
Gerhard Garhofer, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
August 2013

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