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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02205632
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Association between lacquer cracks related to high myopia and the macular pigment optical density [1 day]

Secondary Outcome Measures

1. The macular pigment optical density among high myopic patients [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ophthalmology department, Poitiers University Hospital	Poitiers	Vienne	France	86021

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

• Principal Investigator: Nicolas LEVEZIEL, MD, PhD, Poitiers University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT02205632
• Other Study ID Numbers: MPSII-RMB
• First Posted: Jul 31, 2014
• Last Update Posted: Apr 5, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Apr 5, 2018