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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Corneal Wavefront Aberration; Axial Length, Eye

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected by the Department of Clinical Pharmacology

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Axial eye length	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Refractive error	1 day
Corneal radius	1 day
Pupil diameter	1 day
Anterior chamber depth	1 day
Anterior corneal topography	1 day
Corneal thickness map	1 day

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 9, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Refractive Errors; Corneal Wavefront Aberration
• Other Study ID Numbers: OPHTH-240512