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Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663597
First Posted: August 13, 2012
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
  Purpose

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.


Condition
Refractive Errors Axial Length, Eye Corneal Wavefront Aberration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

Resource links provided by NLM:


Further study details as provided by Gerhard Garhofer, Medical University of Vienna:

Primary Outcome Measures:
  • Axial eye length [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Refractive error [ Time Frame: 1 day ]
  • Corneal radius [ Time Frame: 1 day ]
  • Pupil diameter [ Time Frame: 1 day ]
  • Anterior chamber depth [ Time Frame: 1 day ]
  • Anterior corneal topography [ Time Frame: 1 day ]
  • Corneal thickness map [ Time Frame: 1 day ]

Enrollment: 160
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants will be selected by the Department of Clinical Pharmacology
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663597


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01663597     History of Changes
Other Study ID Numbers: OPHTH-240512
First Submitted: August 9, 2012
First Posted: August 13, 2012
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Refractive Errors
Corneal Wavefront Aberration
Eye Diseases
Corneal Diseases