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

NCT02894424 | Completed

• 1 other identifier: YLR_2015_4
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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

Keywords

Inner limiting membrane; Microperimetry; surgical's dye

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for macular hole surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

CHU Dijon

Dijon, France

Location

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

Study Officials

• Yannick Le Mer, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: February 23, 2017
• Primary Completion: February 23, 2021
• Study Completion: October 5, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

FR (2)