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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01926704
Other study ID # OPHT - 210613
Secondary ID
Status Completed
Phase N/A
First received August 19, 2013
Last updated February 18, 2014
Start date October 2013

Study information

Verified date February 2014
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

Human visual acuity and contrast sensitivity are highly dependent on various different parameters. Each should be optimized for perfect visual performance. However, in real life our eyes lack such parameters, which might lead to unsatisfying results even after spectacle correction or contact lenses.

A promising approach would be to design intra ocular lenses (IOL), which are implanted into the eye for example in the course of cataract extraction and are able to compensate for the human eyes' aberrations.

For example cutoff frequency, edge-sharpness or specific contrast for selected structure sizes would need to be considered. Since, an aberration free optical system is almost impossible and since the impact of each single parameter is not yet known, IOL design parameters would have to be chosen very carefully.

Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but this does not guarantee perfect function after implantation, as our visual system has complex image precessing units form the retina to the brain.

The present study picks one of these parameters and seeks to assess its impact on visual quality in-vivo. By subjectively grading different images with objective changes to image quality by variations of the modulation transfer function (MTF), the potential influence and thus on our subjective visual impression shall be assessed.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Men and women aged between 18 and 35 years, nonsmokers

- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

- Normal ophthalmic findings, emmetropia or = 1 diopter

Exclusion Criteria:

- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

- Treatment in the previous 3 weeks with any drug (except oral contraceptives)

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Austria Department of Clinical Pharmacology, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary subjective image quality 1 study day No
Secondary subjective image sharpness 1 study day No
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