May 2004
Volume 45, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2004
The Effect of Lutein Supplementation in Preservation of Visual Function in Retinitis Pigmentosa; A Randomized Double–Blind Placebo–Controlled Clinical Trial
H. Bahrami; M. Melia; L. Yang; J. Stone; D. Bourdeau; F. Eshraghi; D. Maldenovich; G. Dagnelie
Author Affiliations & Notes
  • H. Bahrami
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • M. Melia
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • L. Yang
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • J. Stone
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • D. Bourdeau
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • F. Eshraghi
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • D. Maldenovich
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • G. Dagnelie
    Wilmer Eye Institute, Department of Ophthalmology, Johsn Hopkins University, Baltimore, MD
  • Footnotes
    Commercial Relationships  H. Bahrami, None; M. Melia, None; L. Yang, None; J. Stone, None; D. Bourdeau, None; F. Eshraghi, None; D. Maldenovich, None; G. Dagnelie, None.
  • Footnotes
    Support  NEI Grant R03 EY 14416 and NCCAM Grant R21 AT00292
Investigative Ophthalmology & Visual Science May 2004, Vol.45, 5161. doi:
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      H. Bahrami, M. Melia, L. Yang, J. Stone, D. Bourdeau, F. Eshraghi, D. Maldenovich, G. Dagnelie; The Effect of Lutein Supplementation in Preservation of Visual Function in Retinitis Pigmentosa; A Randomized Double–Blind Placebo–Controlled Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2004;45(13):5161.

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Abstract

Abstract: : Purpose: To evaluate the effectiveness of lutein supplementation in preventing progressive vision loss in patients with retinitis pigmentosa (RP) Methods: Started in May 2001, as a combined phase I/II trial, 45 adult patients with retinitis pigmentosa were enrolled in this cross–over trial and randomized to two groups. One group received lutein supplementation and for 24 weeks (0 mg/d/PO for 12wks followed by 30 mg/d/PO) and then placebo for 24 weeks, Washout Group. In the other group, Buildup Group, placebo (24 weeks) was administered prior to lutein.. Subjects received multivitamin supplementation in addition to their lutein or placebo throughout the trial. Subjects visual function was measured by multiple tests, including visual acuity, contrast sensitivity, and visual field at up to three levels of illumination at baseline and every 6 weeks in the lab. Also, these tests were performed every week using a previously validated PC–based test in the home. Results: Data from 35 subjects are reported here, and has been analyzed using the Generalized Estimating Equations (GEE) based on intention–to–treat analysis; 16 in the Washout Group, the other 19 in the Buildup Group. Analysis showed a significant beneficial effect of lutein on visual acuity (p<0.001), while contrast sensitivity was worsened significantly (p<0.001) during lutein usage; over the full trial period, though, contrast sensitivity among all subjects improved significantly. Lutein did not have a significant effect in preserving the visual field, but subjects in the Washout Group had significantly slower loss of visual field than those in the Buildup Group (p value: 0.02). No adverse effects were observed for lutein, while one patient could not tolerate multivitamin. Conclusions: Lutein appears to be an effective supplement for preservation of visual function in patients with retinitis pigmentosa, which is important in view of the lack of effective intervention for these patients. Lutein appears to have differential effects on different components of vision loss in the same patients. The anomalous improvement of contrast sensitivity during washout may be attributed to a delayed incorporation and effect of lutein in the retina. Since all subjects were receiving multivitamin throughout the trial, preservation of visual function may in part be attributed to multivitamin, or its combination with lutein. Long–term lutein and multivitamin effects on vision in RP patients need to be further investigated.

Keywords: retinitis • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • low vision 
© 2004, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Copyright © 2025 Association for Research in Vision and Ophthalmology.
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