Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

NCT01663597 | Completed

• 1 other identifier: OPHTH-240512
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors; Axial Length, Eye; Corneal Wavefront Aberration

Outcome Measures

Primary Outcomes (1)

• Axial eye length

  1 day

Secondary Outcomes (6)

• Refractive error

  1 day

• Corneal radius

  1 day

• Pupil diameter

  1 day

• Anterior chamber depth

  1 day

• Anterior corneal topography

  1 day

Study Arms (4)

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 Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected by the Department of Clinical Pharmacology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Refractive Errors; Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Eye Diseases; Corneal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr.

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

AU (1)