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Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery (MICROCOL)

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ClinicalTrials.gov Identifier: NCT02894424
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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. 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.


Condition or disease
Macular Hole Surgery

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for macular hole surgery
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • lower idiopathic macular hole inferior or equal to 400 micron millimeter
  • undergoing macular hole surgery

Exclusion Criteria:

  • Myopia > -3 diopters
  • pregnant women
  • no Health Insurance coverage
  • refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894424


Contacts
Contact: Laurence Salomon, MD, PhD +33 148 036 431 lsalomon@for.paris

Locations
France
Fondation Ophtalmologique A. de Rotchschild Recruiting
Paris, France, 75019
Contact: Laurence Salomon, MD, PhD    +33148036431    lsalomon@for.paris   
Principal Investigator: Yannick Le Mer, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Yannick Le Mer, MD Fondation OPH A de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02894424     History of Changes
Other Study ID Numbers: YLR_2015_4
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Inner limiting membrane
Microperimetry
surgical's dye

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases