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Macular Pigment Optical Density in Healthy Subjects

NCT ID: NCT00993330

Last Updated: 2014-11-14

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

TERMINATED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.

Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database.

Furthermore the nutritional habits and the influence on MP density will be evaluated.

Detailed Description

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Conditions

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Age Related Macular Degeneration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

20 healthy subjects between 18 and 40 years

No interventions assigned to this group

2

20 healthy subjects between 41 and 50 years

No interventions assigned to this group

3

20 healthy subjects between 51 and 60 years

No interventions assigned to this group

4

20 healthy subjects between 61 and 70 years

No interventions assigned to this group

5

20 healthy subjects between 71 and 80 years

No interventions assigned to this group

6

20 healthy subjects between 81 and 90 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects without any signs of AMD
* Age between 18 and 90 years, (20 subjects aged between 18 and 40, 20 subjects aged between 41 and 50, 20 subjects aged between 51 and 60, 20 subjects aged between 61 and 70, 20 subjects aged between 71 and 80, 20 subjects aged between 81 and 90)
* Clear non-lenticular ocular media
* Visual acuity \> 0.6

Exclusion Criteria

* Any sign of AMD, or another retinal or optic nerve head disease
* Ocular surgery within the last 6 months
* Treatment with photosensitizing drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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

Principal Investigators

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Gerhard Garhofer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-310109

Identifier Type: -

Identifier Source: org_study_id