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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894424
Other study ID # YLR_2015_4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 23, 2017
Est. completion date October 5, 2021

Study information

Verified date October 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 5, 2021
Est. primary completion date February 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Dijon Dijon
France Fondation Ophtalmologique A. de Rotchschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02650739 - Optical Coherence Tomography-based Positioning for Macular Hole Surgery N/A