Macular Hole SurgeryMICROCOLNCT02894424
Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery
An observational study of Macular Hole Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years. This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole Surgery
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Feb 2017to 5 Oct 2021
- Phase
- Observational
- 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
Study population: Patients referred for macular hole surgery
Who may be able to join
- age ≥ 18 years
- lower idiopathic macular hole inferior or equal to 600 micron millimeter
- undergoing macular hole surgery
Who cannot join
- Myopia > -3 diopters
- pregnant women
- no Health Insurance coverage
- refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Dijon
Dijon
Fondation Ophtalmologique A. de Rotchschild
Paris, 75019
About this study
Official title: Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery
The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years.
This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery.
Read more
This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models.
It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.
- Conditions
- Macular Hole Surgery
- Keywords
- Inner limiting membrane, Microperimetry, surgical's dye
What is being measured
The primary outcome is the main question the study is designed to answer.
change in retinal sensitivity
change from baseline sensitivity at 1 month after macular hole surgery
Measured: change from baseline sensitivity at 1 month after macular hole surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start23 Feb 2017
- Primary completion23 Feb 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Hole SurgeryStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yannick Le Mer, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894424
- Sponsor's protocol ID
- YLR_2015_4
- Acronym
- MICROCOL
- Status last verified
- Oct 2021
- First submitted
- 5 Sep 2016
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT02894424
- Acronym / sponsor ID
- MICROCOL / YLR_2015_4
- Conditions
- Macular Hole Surgery
- Keywords
- Inner limiting membrane, Microperimetry, surgical's dye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 9 Sep 2016 (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.
The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years.
This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery.
This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models.
It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for macular hole surgery
Key inclusion criteria (3 listed)
- age ≥ 18 years
- lower idiopathic macular hole inferior or equal to 600 micron millimeter
- undergoing macular hole surgery
Key exclusion criteria (4 listed)
- Myopia > -3 diopters
- pregnant women
- no Health Insurance coverage
- refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in retinal sensitivity
Time frame: change from baseline sensitivity at 1 month after macular hole surgery
change from baseline sensitivity at 1 month after macular hole surgery
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 6 Oct 2021.
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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.
Yannick Le Mer, MD principal investigator
Fondation OPH A de Rothschild
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Hole Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites 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 3 inclusion and 4 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
change in retinal sensitivity (time frame: change from baseline sensitivity at 1 month after macular hole surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2021.