NCT00568828

Brief Summary

Earlier investigations have detected low levels of macular pigment (MP) in the center of the fovea and a halo of MP at a higher eccentricity in persons with type 2 idiopathic juxtafoveal teleangiectasia (MACTEL)\[Helb H-M, Charbel Issa P, Pauleikhoff D, Scholl HPN, Holz FG, MacTel-Study Group. Macular Pigment Density and Distribution in Patients with Macular Telangiectasia. ARVO Annual Meeting 2006, Fort Lauderdale, 30.04.-5.05.2006. Program # 5701/B795\]. To date it is not known whether the total MP is reduced in MACTEL or whether even more MP accumulates at higher eccenticities compared to healthy probands. With the suggested study we aim to

  1. 1.investigate Lutein and Zeaxanthin serum levels in MACTEL probands
  2. 2.investigate and quantify MP at the posterior pole of MACTEL probands
  3. 3.detect possible changes of MP concentration and distribution following supplementation with Lutein and Zeaxanthin

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 6, 2007

Status Verified

December 1, 2007

First QC Date

December 5, 2007

Last Update Submit

December 5, 2007

Conditions

Macular TeleangiectasiaMacular Pigment

Keywords

Macular TeleangiectasiaMacular Pigment

Outcome Measures

Primary Outcomes (1)

  • Macular Pigment Optical Density

    3 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

12 patients with Macular Teleangiectasia

You may qualify if:

  • Different distribution of macular pigment in patients with known macular teleangiectasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Ophthalmology, St. Franziskus Hospital

Münster, 48145, Germany

RECRUITING

Study Officials

  • Daniel Pauleikhoff, MD

    Chairman Dep. of Ophthalmology, St.Franziskus Hospital, Muenster, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Pauleikhoff, MD

CONTACT

49-251-933080dapauleikhoff@muenster.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

December 1, 2007

Study Completion

February 1, 2008

Last Updated

December 6, 2007

Record last verified: 2007-12

Locations

DE(1)