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Macular HolesNCT04135638

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

A study testing Cover Group and Fill Group in people with Macular Holes, run by University of Molise at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Macular Holes
What is being tested?
Cover Group and Fill Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteItaly
Study dates
1 Nov 2019to 10 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with idiopatic macular holes

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ciro Costagliola, MD contact

+390874404448

ciro.costagliola@unimol.it

Italy1 site, 1 recruiting

  • University of Molise

    Campobasso

    Costagliola Ciro, 08744092269, ciro.costagliola@unimol.it

    Recruiting

Other trials in Italy

About this study

Official title: Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery

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.

Read the 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.

Conditions
Macular Holes
Being tested
Cover Group, Fill Group
Medical subject headings
Retinal Perforations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cover GroupProcedure or surgery

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

  • Fill GroupProcedure or surgery

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

Study groups in NCT04135638
Study groupRoleWhat they receive
Cover Group (CG)OtherAll 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
Receives: Procedure: Cover Group
Fill Group (FG)OtherAll 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
Receives: Procedure: Fill Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual outcome linked to "Cover" and "Fill" procedures

    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.

    Measured: five months

  2. Anatomical outcome linked to "Cover" and "Fill" procedures

    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

    Measured: five months

Secondary outcomes (1)

  1. Macular sensitivity linked to "Cover" and "Fill" procedures

    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.

    Measured: five months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2019
  2. Study start1 Nov 2019 (estimated)
  3. Primary completion31 Mar 2020 (estimated)
  4. Study completion10 Apr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135638
Sponsor's protocol ID
14738
Status last verified
Oct 2019
First submitted
4 Oct 2019
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.

    PubMed 2025167

  • Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.

    PubMed 20541263

  • Rossi T, Gelso A, Costagliola C, Trillo C, Costa A, Gesualdo C, Ripandelli G. Macular hole closure patterns associated with different internal limiting membrane flap techniques. Graefes Arch Clin Exp Ophthalmol. 2017 Jun;255(6):1073-1078. doi: 10.1007/s00417-017-3598-9. Epub 2017 Feb 4.

    PubMed 28161828

  • Molina-Martin A, Perez-Cambrodi RJ, Pinero DP. Current Clinical Application of Microperimetry: A Review. Semin Ophthalmol. 2018;33(5):620-628. doi: 10.1080/08820538.2017.1375125. Epub 2017 Oct 9.

    PubMed 28991503

  • Chen WC, Wang Y, Li XX. Morphologic and functional evaluation before and after successful macular hole surgery using spectral-domain optical coherence tomography combined with microperimetry. Retina. 2012 Oct;32(9):1733-42. doi: 10.1097/IAE.0b013e318242b81a.

    PubMed 22466479

  • Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26.

    PubMed 23620091

  • Chen SN. Large semicircular inverted internal limiting membrane flap in the treatment of macular hole in high myopia. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2337-2345. doi: 10.1007/s00417-017-3808-5. Epub 2017 Oct 10.

    PubMed 28993905

  • Aurora A, Seth A, Sanduja N. Cabbage Leaf Inverted Flap ILM Peeling for Macular Hole: A Novel Technique. Ophthalmic Surg Lasers Imaging Retina. 2017 Oct 1;48(10):830-832. doi: 10.3928/23258160-20170928-08.

    PubMed 29020427

  • Rizzo S, Tartaro R, Barca F, Caporossi T, Bacherini D, Giansanti F. INTERNAL LIMITING MEMBRANE PEELING VERSUS INVERTED FLAP TECHNIQUE FOR TREATMENT OF FULL-THICKNESS MACULAR HOLES: A COMPARATIVE STUDY IN A LARGE SERIES OF PATIENTS. Retina. 2018 Sep;38 Suppl 1:S73-S78. doi: 10.1097/IAE.0000000000001985.

    PubMed 29232338

  • Wang Z, Qi Y, Liang X, Yu Y, Chen J, Wang J, Liu X, Liu W. MP-3 measurement of retinal sensitivity in macular hole area and its predictive value on visual prognosis. Int Ophthalmol. 2019 Sep;39(9):1987-1994. doi: 10.1007/s10792-018-1032-x. Epub 2018 Oct 3.

    PubMed 30284091

  • Sun Z, Gan D, Jiang C, Wang M, Sprecher A, Jiang AC, Xu G. Effect of preoperative retinal sensitivity and fixation on long-term prognosis for idiopathic macular holes. Graefes Arch Clin Exp Ophthalmol. 2012 Nov;250(11):1587-96. doi: 10.1007/s00417-012-1997-5. Epub 2012 Mar 24.

    PubMed 22441811

  • Tarita-Nistor L, Gonzalez EG, Mandelcorn MS, Lillakas L, Steinbach MJ. Fixation stability, fixation location, and visual acuity after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):84-9. doi: 10.1167/iovs.08-2342. Epub 2008 Aug 29.

    PubMed 18757517

  • Cacciamani A, Gelso A, Di Nicola M, Scarinci F, Ripandelli G, Costagliola C, Rossi T. Inverted ILM-flap techniques variants for macular hole surgery: randomized clinical trial to compare retinal sensitivity and fixation stability. Sci Rep. 2020 Sep 28;10(1):15832. doi: 10.1038/s41598-020-72774-1.

    PubMed 32985592

Questions about this trial

What is this clinical trial studying?

A study testing Cover Group and Fill Group in people with Macular Holes, run by University of Molise at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ciro Costagliola, MD (+390874404448, ciro.costagliola@unimol.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual outcome linked to "Cover" and "Fill" procedures (time frame: five months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04135638, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.

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