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Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison

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ClinicalTrials.gov Identifier: NCT04135638
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
Ospedale Policlinico San Martino
Fondazione G.B. Bietti, IRCCS
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Information provided by (Responsible Party):
Ciro Costagliola, University of Molise

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.

Condition or disease Intervention/treatment Phase
Macular Holes Procedure: Cover Group Procedure: Fill Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 10, 2020

Arm Intervention/treatment
Cover Group (CG)

All patients will undergo a 25G standard 3-port PPV with posterior vitreous detachment induction (if not already present), ILM staining with 0,25 g/l of brilliant blue-G and creation of a 360°ILM flap around the MH rim.

Phakic patients will undergo combined phacoemulsification with IOL implant in-the-bag.

In the Cover Group the ILM flap will be folded as a single layer to bridge tissue dehiscence during air-fluid exchange. All eyes will recive a mixture of 20% sulfur hexafluoride tamponade and will be instructed to position face down for 4 hours a day during the first 3 days post-operative

Procedure: Cover Group
"Cover" when the ILM flap is everted over the MH gap in a single layer

Fill Group (FG)

All patients will undergo a 25G standard 3-port PPV with posterior vitreous detachment induction (if not already present), ILM staining with 0,25 g/l of brilliant blue-G and creation of a 360°ILM flap around the MH rim.

Phakic patients will undergo combined phacoemulsification with IOL implant in-the-bag.

In the Fill Group, multiple layers of ILM will be deliberately folded within the loss of tissue before air-fluid exchange. All eyes will receive a mixture of 20% sulfur hexafluoride tamponade and will be instructed to position face down for 4 hours a day during the first 3 days post-operative

Procedure: Fill Group
"Fill" when the ILM is folded into multiple layers within the MH




Primary Outcome Measures :
  1. Visual outcome linked to "Cover" and "Fill" procedures [ Time Frame: 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.


  2. Anatomical outcome linked to "Cover" and "Fill" procedures [ Time Frame: 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 Outcome Measures :
  1. Macular sensitivity linked to "Cover" and "Fill" procedures [ Time Frame: 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.




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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135638


Contacts
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Contact: Ciro Costagliola, MD +390874404448 ciro.costagliola@unimol.it

Locations
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Italy
University of Molise Recruiting
Campobasso, Italy
Contact: Costagliola Ciro    08744092269    ciro.costagliola@unimol.it   
Sponsors and Collaborators
University of Molise
Ospedale Policlinico San Martino
Fondazione G.B. Bietti, IRCCS
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Investigators
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Principal Investigator: Ciro Costagliola University of Molise
Publications:

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Responsible Party: Ciro Costagliola, Full Professor in Ophthalmology, University of Molise
ClinicalTrials.gov Identifier: NCT04135638    
Other Study ID Numbers: 14738
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases