High MyopiaNCT02205632
Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.
A study testing MPS II in people with High Myopia, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Myopia
- What is being tested?
- MPS II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
ophthalmology department, Poitiers University Hospital
Poitiers, VIENNE, 86021
About this study
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.
- Conditions
- High Myopia
- Being tested
- MPS II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPS IIDevice
| Study group | Role | What they receive |
|---|---|---|
| High myopic patients with lacker craks | Other | Not described Receives: Device: MPS II |
| High myopic patients without lacker cracks | Other | Not described Receives: Device: MPS II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between lacquer cracks related to high myopia and the macular pigment optical density
Measured: 1 day
Secondary outcomes (1)
The macular pigment optical density among high myopic patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas LEVEZIEL, MD, PhD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205632
- Sponsor's protocol ID
- MPSII-RMB
- Status last verified
- Apr 2018
- First submitted
- 22 Jul 2014
- Last updated
- 11 Jun 2026
- Results posted
- No
Publications
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.
PubMed 27544327
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.
- ClinicalTrials.gov ID
- NCT02205632
- Acronym / sponsor ID
- MPSII-RMB
- Conditions
- High Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High myopic patients with lacker craks | Other | Device: MPS II |
| High myopic patients without lacker cracks | Other | Device: MPS II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPS II | Device | High myopic patients with lacker craks, High myopic patients without lacker cracks |
Primary outcome
Association between lacquer cracks related to high myopia and the macular pigment optical density
Time frame: 1 day
1 secondary outcome
The macular pigment optical density among high myopic patients
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 27544327Benoudis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas LEVEZIEL, MD, PhD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPS II in people with High Myopia, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between lacquer cracks related to high myopia and the macular pigment optical density (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02205632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.