Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01663597
Collaborator
(none)
160
1
9
17.8

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    May 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Axial eye length [1 day]

    Secondary Outcome Measures

    1. Refractive error [1 day]

    2. Corneal radius [1 day]

    3. Pupil diameter [1 day]

    4. Anterior chamber depth [1 day]

    5. Anterior corneal topography [1 day]

    6. Corneal thickness map [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gerhard Garhofer, Assoc. Prof. Priv. Doz. Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT01663597
    Other Study ID Numbers:
    • OPHTH-240512
    First Posted:
    Aug 13, 2012
    Last Update Posted:
    Aug 29, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 29, 2013