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

Completed

• Conditions: Macular Hole Surgery

• Registration Number: NCT02894424
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Study Start: 2017-02-23
• Primary Completion: 2021-02-23
• Status Verified: 2021-10
• Study Completion: 2021-10-05
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in retinal sensitivity	change from baseline sensitivity at 1 month after macular hole surgery	change from baseline sensitivity at 1 month after macular hole surgery

Trial Locations

Locations (2)

Fondation Ophtalmologique A. de Rotchschild; 🇫🇷 Paris, France

CHU Dijon; 🇫🇷 Dijon, France