Ignite Creation Date:
2024-05-05 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00568828
Status:
UNKNOWN
Last Update Posted:
2007-12-06
First Post:
2007-12-05
Brief Title:
MPOD in Macular Teleangiectasia Following Supplementation of Lutein and Zeaxanthin
Sponsor:
The Lowy Medical Research Institute Limited
Organization:
The Lowy Medical Research Institute Limited
Study Overview
Official Title:
Pilot Study to Evaluate the Changes of Macular Pigment Optical Density in Patients With Idiopathic Macular Teleangiectasia Following Supplementation of Lutein and Zeaxanthin
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MacTEL-Supp
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 MACTELHelb 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 3004-5052006 Program 5701B795 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 investigate Lutein and Zeaxanthin serum levels in MACTEL probands
2 investigate and quantify MP at the posterior pole of MACTEL probands
3 detect possible changes of MP concentration and distribution following supplementation with Lutein and Zeaxanthin
1 investigate Lutein and Zeaxanthin serum levels in MACTEL probands
2 investigate and quantify MP at the posterior pole of MACTEL probands
3 detect possible changes of MP concentration and distribution following supplementation with Lutein and Zeaxanthin
Detailed Description:
Rationale for performing this study 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 MACTELHelb 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 3004-5052006 Program 5701B795 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 investigate Lutein and Zeaxanthin serum levels in MACTEL probands
2 investigate and quantify MP at the posterior pole of MACTEL probands
3 detect possible changes of MP concentration and distribution following supplementation with Lutein and Zeaxanthin
The suggested study During this study we plan to select at least 10 MACTEL probands with different patterns of MP distribution including
1 those with detectable accumulation of MP in the center and segmental reduction of MP temporally
2 those with nearly no central accumulation and and larger area of reduced MP temporally
3 those with no detectable accumulation of MP in the center and a halo of MP at a more eccentric location These probands will be supplemented with Lutein L and Zeaxanthin Z 12mg L and 1 mg Z provided as esters 120mg Vitamin C 176 mg Vitamin E 10mg Zink 40µg Selen Ocuvite Lutein for a duration of nine months During the supplementation and three months after stop of supplementation probands will be investigated every three months including
1 ophthalmologic investigation 2 fundus photography 3 measurement of MP with a modified Heidelberg retina Angiograph employing two excitation wavelengths 514 and 488nm 4 measurement of L and Z in serum
Aim of the study
1 Investigation of changes of MP concentration and distribution following supplementation of L and Z in MACTEl probands
2 How do serum levels of L and Z change in these probands
Visit
V1 Screening Start of supplementat V2 V3 V4 End of supplemenation V5 after stop of intake Months 0 3 6 9 12 general Informed consent X Medical history X in- and exclusion criteria X concommitant medication X X X X X Adverse events X X X X Pill count X X X Vital signs BMI X X Slitlamp investigation X X X X X Fundusphotography X X Visual acuity X X X X X Supplementation X X X Measurement of Xanthophylls Eye MPOD HRA X X X X X Food frequency questionnaire X X Blood collection For Heparin Plasma to quantify Xanthophylls and Lipids X X X X X
Probands resident within a perimeter of 40km around the clinic will be preferentially selected to lower travel expenses Recruitment takles place during regular visits in the course of the MACTEL study For the angiography a vein will be punctated so that no additional punction is needed Serum ist centrifuged at 1500g for 15min and kept at -70C until analyse Analyse of the Xanthophylls and Lipids in serum will be performed at the central laboratory of the University of Münster
Autofluorescence imaging is part of study protocol for MACTEL Study Two main images will be taken one with an excitation wavelength of 488nm good absorption by MP and one with 514nm poor absorption by MP The digital subtration of both images provides a map of MP density around the fovea
Inclusion criteria Informed consent Age at least 18y Type 2 IMT Healthy general condition At least one eye free from lens- or retina problems interfering with MP measurement with the modofied Heidelberg retina angiograph Exclusion criteria No informed consent Younger than als 18 y Intake of Supplements containing L and Z 3mg L und 1mg Z during the last 6 months Bad general condition unintended loss of weight 10 within the last 3 monhs
1 investigate Lutein and Zeaxanthin serum levels in MACTEL probands
2 investigate and quantify MP at the posterior pole of MACTEL probands
3 detect possible changes of MP concentration and distribution following supplementation with Lutein and Zeaxanthin
The suggested study During this study we plan to select at least 10 MACTEL probands with different patterns of MP distribution including
1 those with detectable accumulation of MP in the center and segmental reduction of MP temporally
2 those with nearly no central accumulation and and larger area of reduced MP temporally
3 those with no detectable accumulation of MP in the center and a halo of MP at a more eccentric location These probands will be supplemented with Lutein L and Zeaxanthin Z 12mg L and 1 mg Z provided as esters 120mg Vitamin C 176 mg Vitamin E 10mg Zink 40µg Selen Ocuvite Lutein for a duration of nine months During the supplementation and three months after stop of supplementation probands will be investigated every three months including
1 ophthalmologic investigation 2 fundus photography 3 measurement of MP with a modified Heidelberg retina Angiograph employing two excitation wavelengths 514 and 488nm 4 measurement of L and Z in serum
Aim of the study
1 Investigation of changes of MP concentration and distribution following supplementation of L and Z in MACTEl probands
2 How do serum levels of L and Z change in these probands
Visit
V1 Screening Start of supplementat V2 V3 V4 End of supplemenation V5 after stop of intake Months 0 3 6 9 12 general Informed consent X Medical history X in- and exclusion criteria X concommitant medication X X X X X Adverse events X X X X Pill count X X X Vital signs BMI X X Slitlamp investigation X X X X X Fundusphotography X X Visual acuity X X X X X Supplementation X X X Measurement of Xanthophylls Eye MPOD HRA X X X X X Food frequency questionnaire X X Blood collection For Heparin Plasma to quantify Xanthophylls and Lipids X X X X X
Probands resident within a perimeter of 40km around the clinic will be preferentially selected to lower travel expenses Recruitment takles place during regular visits in the course of the MACTEL study For the angiography a vein will be punctated so that no additional punction is needed Serum ist centrifuged at 1500g for 15min and kept at -70C until analyse Analyse of the Xanthophylls and Lipids in serum will be performed at the central laboratory of the University of Münster
Autofluorescence imaging is part of study protocol for MACTEL Study Two main images will be taken one with an excitation wavelength of 488nm good absorption by MP and one with 514nm poor absorption by MP The digital subtration of both images provides a map of MP density around the fovea
Inclusion criteria Informed consent Age at least 18y Type 2 IMT Healthy general condition At least one eye free from lens- or retina problems interfering with MP measurement with the modofied Heidelberg retina angiograph Exclusion criteria No informed consent Younger than als 18 y Intake of Supplements containing L and Z 3mg L und 1mg Z during the last 6 months Bad general condition unintended loss of weight 10 within the last 3 monhs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None