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
  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 Medical University of Vienna:

Primary Outcome Measures:
  • Axial eye length [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663597

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

No publications provided

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
Study First Received: August 9, 2012
Last Updated: August 28, 2013
Health Authority: Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on April 15, 2014