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NCT02205632 Clinical Trial

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

High Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02205632
Other study ID # MPSII-RMB
Secondary ID
Status Completed
Phase N/A
First received July 22, 2014
Last updated April 3, 2018
Start date February 2014
Est. completion date November 2014

Study information
Verified date April 2018
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MPS II

Locations
Country Name City State
France ophthalmology department, Poitiers University Hospital Poitiers Vienne

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association between lacquer cracks related to high myopia and the macular pigment optical density 1 day
Secondary The macular pigment optical density among high myopic patients 1 day
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