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Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

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Medical University of Vienna

Status

Completed

Conditions

Corneal Wavefront Aberration
Refractive Errors
Axial Length, Eye

Study type

Observational

Funder types

Other

Identifiers

NCT01663597
OPHTH-240512

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

160 participants in 4 patient groups

Cohort 1
Description:
40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters
Cohort 2
Description:
40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter
Cohort 3
Description:
40 subjects with emmetropia, -1 diopter to +1 diopter
Cohort 4
Description:
40 subjects with hyperopia, +1.01 diopter and more

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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