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

April 3, 2018 updated by: Poitiers University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Vienne
      • Poitiers, Vienne, France, 86021
        • ophthalmology department, Poitiers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: High myopic patients with lacker craks
Device: MPS II
Other: High myopic patients without lacker cracks
Device: MPS II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association between lacquer cracks related to high myopia and the macular pigment optical density
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
The macular pigment optical density among high myopic patients
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPSII-RMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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