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

Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02894424
Acronym
MICROCOL
Enrollment
34
Registered
2016-09-09
Start date
2017-02-23
Completion date
2021-10-05
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole Surgery

Keywords

Inner limiting membrane, Microperimetry, surgical's dye

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.

Interventions

None listed

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in retinal sensitivitychange from baseline sensitivity at 1 month after macular hole surgerychange from baseline sensitivity at 1 month after macular hole surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026