Relationships Between Macular Pigment Optical Density and... | NCT02205632

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

NCT02205632

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

High Myopia

Interventions

MPS II

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jul 22, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Jul 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High myopic patients with lacker craks	Other		Device: MPS II
High myopic patients without lacker cracks	Other		Device: MPS II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MPS II	Device		High myopic patients with lacker craks High myopic patients without lacker cracks

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas LEVEZIEL, MD, PhD	Poitiers University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ophthalmology department, Poitiers University Hospital		Poitiers	VIENNE	86021	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27544327	Result	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.