NCT02894424: MICROCOL

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

Completed Last updated 6 October 2021

What this trial tests

trial in Macular Hole Surgery in 34 participants. Completed in 5 October 2021.

Timeline

23 February 2017

Primary endpoint
23 February 2021

5 October 2021

Quick facts

Lead sponsor	Fondation Ophtalmologique Adolphe de Rothschild
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	23 February 2017
Primary completion	23 February 2021
Estimated completion	5 October 2021
Sites	2 locations across France

Conditions studied

• Macular Hole Surgery — all drugs for Macular Hole Surgery →

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild — full company profile →

Who can join

18 and older, any sex, with Macular Hole Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.