Retinal Perforations Clinical Trial
Official title:
Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study
Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people
aged over 60, and twice common in women than men.
The vast majority of cases are idiopathic. Without treatment, the macular hole evolves
through a series of stages until the extension of the diameter (up to 500 microns and higher
values). With a fully developed macular hole, patients complain of metamorphopsia and
decreased visual acuity.
This pathology has clearly benefited from advances in microsurgery and better understanding
of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana
vitrectomy with or without internal limiting membrane (ILM) peeling and placement of
intraocular gas tamponade.
The postoperative closure rate is close to 80%, but strongly depends on the initial
characteristics of the hole, its diameter remaining the main prognostic factor. Thus for
macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular
holes above 400 microns. In case of surgical failure, one or more reoperations can be
proposed, but with a lower closure rate.
The quest for a surgical technique presenting a greater success rate is a common goal to all
retinologists.
Here the investigators propose a new surgical technique, derived from the FLAP method, and
consisting of an inner limiting membrane transposition.
The objective of this study is to evaluate the feasibility of a new surgical technique for
the treatment of macular holes already operated but without macular hole closure, allowing
these patients a new therapeutic alternative. The success of this technique will be confirmed
by detecting postoperatively the presence of the transposed internal limiting membrane into
the foveal region.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05875909 -
Corneal Flap Transplantation for Macular Hole Repair of High Myopia
|
N/A |