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

NCT ID: NCT02894424

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2021-10-05

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.

Conditions

Macular Hole Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• lower idiopathic macular hole inferior or equal to 600 micron millimeter
• undergoing macular hole surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yannick Le Mer, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Locations

CHU Dijon

Dijon, , France

Fondation Ophtalmologique A. de Rotchschild

Paris, , France

Countries

France

Other Identifiers

YLR_2015_4

Identifier Type: -

Identifier Source: org_study_id