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
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|
|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|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894424
|Contact: Laurence Salomon, MD, PhD||+33 148 036 email@example.com|
|Fondation Ophtalmologique A. de Rotchschild||Recruiting|
|Paris, France, 75019|
|Contact: Laurence Salomon, MD, PhD +33148036431 firstname.lastname@example.org|
|Principal Investigator: Yannick Le Mer, MD|
|Principal Investigator:||Yannick Le Mer, MD||Fondation OPH A de Rothschild|