Macular Holes
Conditions
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.
Interventions
PROCEDURECover Group
Cover when the ILM flap is everted over the MH gap in a single layer
PROCEDUREFill Group
Fill when the ILM is folded into multiple layers within the MH
Sponsors
Ospedale Policlinico San Martino
Fondazione G.B. Bietti, IRCCS
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
University of Molise
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual outcome linked to Cover and Fill procedures | five months | To report : \- Best Corrected Visual Acuity (BCVA expressed in logMAR) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. |
| Anatomical outcome linked to Cover and Fill procedures | five months | To report: \- closure rate (μm) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macular sensitivity linked to Cover and Fill procedures | five months | To report: * Retinal Sensitivity (RS expressed in dB) * Fixation Stability (FS expressed as: 0 = stable, 1 = relatively (stable,2 = unstable) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. |
Countries
Italy
Contacts
Primary ContactCiro Costagliola, MD
Outcome results
None listed