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Status unknownNCT03287102MARTIALUpdated Jan 30, 2018

Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)

An interventional study of Macular hole surgery in Macula Hole, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling

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Conditions studied

  • Macula Hole

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In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's planned enrollment of 130 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Browse Central Hospital, Nancy, France studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients older than 18 years old

Exclusion criteria

Exclusion Criteria:

  • Underage patients
  • History of intraocular surgery (except for cataract surgery)
  • Macular hole secondary to trauma, diabetic retinopathy, uveitis or associated with retinal detachment
  • Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Other
    Temporal inverted ILM peeling group

    The internal limiting membrane is peeled from the temporal side of the fovea only

    Procedure: Macular hole surgery

  • Other
    Complete ILM peeling group

    The internal limiting membrane is completely removed around the fovea

    Procedure: Macular hole surgery

Interventions

  • ProcedureMacular hole surgery

    Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade

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What researchers measure

Primary outcomes

  1. Number of dimples on optical coherence tomography

    Incidence of DONFL appearance

    Time frame: 3 months after surgery

Secondary outcomes

  1. Retinal sensitivity on microperimetry testing (decibel)

    Time frame: 3 months after surgery

  2. Macular hole closure rate on optical coherence tomography

    Time frame: 3 months after surgery

  3. Visual acuity (Logarithm of the Minimum Angle of Resolution)

    Time frame: 3 months after surgery

  4. Ellipsoide zone defect on optical coherence tomography

    Time frame: 3 months after surgery

  5. External limiting membrane defect on optical coherence tomography

    Time frame: 3 months after surgery

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Study locations

1 site
  • Brabois Hospital
    Vandœuvre-lès-Nancy, 54500, France
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References and documents

Publications

  • Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555. PubMed 25946691 ↗
  • Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042. PubMed 24263468 ↗
  • Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17. PubMed 23077227 ↗
  • 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 ↗
  • Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83. doi: 10.1016/s0161-6420(01)00856-9. PubMed 11733271 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2018; primary completion for Feb 2020, 24 months later.

Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 24 months is below that.

Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2017
First posted
Sep 19, 2017
StartEst.
Feb 1, 2018
Primary completionEst.
Feb 1, 2020
CompletionEst.
Feb 1, 2020
Last update
Jan 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03287102
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Feb 1, 2018 (estimated)
Primary completion
Feb 1, 2020 (estimated)
Completion
Feb 1, 2020 (estimated)
Last update
Jan 30, 2018

Study contacts

Jean-Baptiste CONART
Contact
jbconart@hotmail.com
+33383155203
Jean-Baptiste CONART
principal investigator · Brabois Hospital, Nancy, France

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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