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Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02205632
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the macular area.

Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be evaluated by its optical density.

Reduced macular pigment level is a significant risk factor for age-macular degeneration. The nutritional intake can minimise the risk of age-macular degeneration.

Condition or disease Intervention/treatment Phase
High Myopia Device: MPS II Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Actual Study Start Date : February 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
High myopic patients with lacker craks Device: MPS II
High myopic patients without lacker cracks Device: MPS II

Primary Outcome Measures :
  1. Association between lacquer cracks related to high myopia and the macular pigment optical density [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. The macular pigment optical density among high myopic patients [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >18 years-old
  • High axial myopia < -6 dioptries
  • Presence or not of lacquer cracks in Bruch's membrane in one or both eyes
  • Patients with social security coverage

Exclusion Criteria:

  • Age <18 years-old
  • Amblyopia in the studied eye
  • Prior ocular surgery
  • Corneal disease or severe dry eye syndrome
  • Other retinal disease: diabetic retinopathy, age-related macular degeneration, macular hole, epiretinal membrane central
  • Extensive chorioretinal atrophy
  • Allergy to tropicamide
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02205632

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ophthalmology department, Poitiers University Hospital
Poitiers, Vienne, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
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Principal Investigator: Nicolas LEVEZIEL, MD, PhD Poitiers University Hospital

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Responsible Party: Poitiers University Hospital Identifier: NCT02205632     History of Changes
Other Study ID Numbers: MPSII-RMB
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018