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

Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03287102

Acronym

MARTIAL

Enrollment

130

Registered

2017-09-19

Start date

2018-02-01

Completion date

2020-02-01

Last updated

2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macula Hole

Brief 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

Interventions

PROCEDUREMacular hole surgery

Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients older than 18 years old

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of dimples on optical coherence tomography	3 months after surgery	Incidence of DONFL appearance

Secondary

Measure	Time frame
Retinal sensitivity on microperimetry testing (decibel)	3 months after surgery
Macular hole closure rate on optical coherence tomography	3 months after surgery
Visual acuity (Logarithm of the Minimum Angle of Resolution)	3 months after surgery
Ellipsoide zone defect on optical coherence tomography	3 months after surgery
External limiting membrane defect on optical coherence tomography	3 months after surgery

Countries

France

Contacts

Primary ContactJean-Baptiste CONART

jbconart@hotmail.com+33383155203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026