Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

NCT ID: NCT01663597

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Refractive Errors Axial Length, Eye Corneal Wavefront Aberration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters

No interventions assigned to this group

Cohort 2

40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter

No interventions assigned to this group

Cohort 3

40 subjects with emmetropia, -1 diopter to +1 diopter

No interventions assigned to this group

Cohort 4

40 subjects with hyperopia, +1.01 diopter and more

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. Priv. Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHTH-240512

Identifier Type: -

Identifier Source: org_study_id