NCT02205632

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 11, 2026

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

July 22, 2014

Last Update Submit

June 9, 2026

Conditions

High Myopia

Outcome Measures

Primary Outcomes (1)

  • Association between lacquer cracks related to high myopia and the macular pigment optical density

    1 day

Secondary Outcomes (1)

  • The macular pigment optical density among high myopic patients

    1 day

Study Arms (2)

High myopic patients with lacker craks

OTHER
Device: MPS II

High myopic patients without lacker cracks

OTHER
Device: MPS II

Interventions

MPS IIDEVICE
High myopic patients with lacker craksHigh myopic patients without lacker cracks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ophthalmology department, Poitiers University Hospital

Poitiers, VIENNE, 86021, France

Location

Related Publications (1)

  • Benoudis L, Ingrand P, Jeau J, Lichtwitz O, Boissonnot M, Leveziel N. Relationships between macular pigment optical density and lacquer cracks in high myopia. J Fr Ophtalmol. 2016 Sep;39(7):615-21. doi: 10.1016/j.jfo.2016.04.001. Epub 2016 Aug 18.

    PMID: 27544327RESULT

Study Officials

  • Nicolas LEVEZIEL, MD, PhD

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 31, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 11, 2026

Record last verified: 2018-04

Locations

FR(1)