NCT01926704

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

Same day

First QC Date

August 19, 2013

Last Update Submit

February 18, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • subjective image quality

    1 study day

Secondary Outcomes (1)

  • subjective image sharpness

    1 study day

Study Arms (1)

healthy, young subjects

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy, male and female subjects 18-35 years non-smokers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1080, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. Prof. Dr.med.univ.

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations