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NCT Number: NCT01663597

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Axial eye length

    Time frame: 1 day

Secondary outcomes

  1. Refractive error

    Time frame: 1 day

  2. Corneal radius

    Time frame: 1 day

  3. Pupil diameter

    Time frame: 1 day

  4. Anterior chamber depth

    Time frame: 1 day

  5. Anterior corneal topography

    Time frame: 1 day

  6. Corneal thickness map

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2012
Registry last updated
Aug 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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