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
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.
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 →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.
Patients referred for macular hole surgery
Exclusion Criteria:
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
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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Fondation Ophtalmologique Adolphe de Rothschild