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CompletedNCT02894424MICROCOLUpdated Oct 6, 2021

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

An observational study in Macular Hole Surgery, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Macular Hole Surgery

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Keywords

  • Inner limiting membrane
  • Microperimetry
  • surgical's dye
03

In context

Retinal Perforations

156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.

This study's enrollment of 34 is below the median of 42 across 51 observational studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for macular hole surgery

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Myopia > -3 diopters
  • pregnant women
  • no Health Insurance coverage
  • refusal to participate in the study
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. change in retinal sensitivity

    change from baseline sensitivity at 1 month after macular hole surgery

    Time frame: change from baseline sensitivity at 1 month after macular hole surgery

07

Study locations

2 sites
  • CHU Dijon
    Dijon, France
  • Fondation Ophtalmologique A. de Rotchschild
    Paris, 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02894424
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Sep 9, 2016
Start date
Feb 23, 2017
Primary completion
Feb 23, 2021
Completion
Oct 5, 2021
Last update
Oct 6, 2021

Study contacts

Yannick Le Mer, MD
principal investigator · Fondation OPH A de Rothschild

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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