Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date October 22, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
Official Title  ICMJE Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Macular Holes
Intervention  ICMJE
  • Procedure: Cover Group
    "Cover" when the ILM flap is everted over the MH gap in a single layer
  • Procedure: Fill Group
    "Fill" when the ILM is folded into multiple layers within the MH
Study Arms  ICMJE
  • 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

    Intervention: Procedure: Cover Group
  • 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

    Intervention: Procedure: Fill Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2019)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 10, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ciro Costagliola, MD +390874404448 ciro.costagliola@unimol.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04135638
Other Study ID Numbers  ICMJE 14738
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ciro Costagliola, University of Molise
Study Sponsor  ICMJE University of Molise
Collaborators  ICMJE
  • Ospedale Policlinico San Martino
  • Fondazione G.B. Bietti, IRCCS
  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Investigators  ICMJE
Principal Investigator: Ciro Costagliola University of Molise
PRS Account University of Molise
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP