Clinical trial NCT04135638: Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
Official title: Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Lead sponsor: University of Molise
Sponsor class: OTHER
Collaborators: name: Ospedale Policlinico San Martino
name: Fondazione G.B. Bietti, IRCCS
name: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
First posted: 2019-10-22
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.

Detailed description: Patients will be randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. "Cover" when the ILM flap is everted over the MH gap in a single layer, "Fill" when the ILM is folded into multiple layers within the MH. All patients will undergo BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery.

Purpose of the study is to report retinal differential sensitivity and fixation stability as well as anatomic and visual outcomes of patients operated on for idiopathic MH and randomly assigned to Fill or Cover Groups.

Eligibility criteria: Inclusion Criteria:

* patients with idiopatic macular holes

Exclusion Criteria:

* Patients with MH duration greater than 6 months
* myopia exceeding 6 diopters
* history of trauma
* previous ocular surgery except uncomplicated cataract extraction with in-the-bag IOL implantation
* any ocular illness including glaucoma, uveitis, optic nerve pathology

Primary outcomes:
measure: Visual outcome linked to "Cover" and "Fill" procedures
timeFrame: five months
measure: Anatomical outcome linked to "Cover" and "Fill" procedures
timeFrame: five months
Secondary outcomes:
measure: Macular sensitivity linked to "Cover" and "Fill" procedures
timeFrame: five months
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: University of Molise
Study officials:
affiliation: University of Molise
name: Ciro Costagliola
role: PRINCIPAL_INVESTIGATOR
References:
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