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NCT Number: NCT06359548

PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School

Shanghai, China

Location status: Recruiting

Location contact

Tian Tian, Dr.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography.
  • Age ranges from 50 to 80 years.
  • Do not participate in other clinical studies.
  • Agree to sign an informed consent form with good compliance.

Exclusion criteria

  • Traumatic macular hole.
  • Combined with serious epiretinal membrane.
  • Combined with diabetic retinopathy, hypertensive retinopathy.
  • Combined with other ocular diseases, such as keratitis,uveitis,retinal vasculitis.
  • Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm.
  • History of intraocular surgery.
  • Presence of staphyloma.
  • Other ocular diseases that influence macular microstructure or visual function.

Treatment and study plan

Peeled ILM Reposition

Procedure

The ILM was stained using 0.1 mL of indocyanine green(ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc) at a point away from the center of MH around one disc diameter in inferior quadrant of macular area. First, a horizontal ILM strip was peeled off with a width approximately 1.5 to 2.5 disc diameter. Then, the edge of the horizontal ILM strip was grasped and peeled from inferior to superior area continuously.Then the "ILM roll" was flattened back to peeled area assisted with approximately 1.0 mL of PFO (Perfluoron, Alcon Laboratories, Inc). The position of the fixed ILM flap was adjusted under PFO bubble using flute needle or forceps if required.

Other names: ILM Flap reposition, ILM Flap covering

ILM peeling

Procedure

The ILM was stained using 0.1 mL of indocyanine green(ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc). The strand of ILM was peeled off radially from the foveal center to the vascular arcade. As a result, a round-shaped, 2.5-disk diameter to 3.5-disk diameter ILM-peeled area was created.

Primary outcomes

  1. The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively

    Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

    The change of BCVA from baseline to 6-month postoperatively

Secondary outcomes

  1. The MH closure rate

    Time frame: 1-month postoperatively

    The MH closure rate at 1-month postoperatively

  2. The range of inner retinal dimpling

    Time frame: 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

    The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA)

  3. Postoperative retinal thickness

    Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

    With the Thickness Map protocol of the OCT, the full retinal thickness (from ILM to retinal pigment epithelium), inner retinal thickness (from ILM to inner plexiform layer (IPL)), and outer retinal thickness (from IPL to retinal pigment epithelium) of the fovea, parafovea, and perifovea were recorded, respectively.

  4. The fixation stability and sensitivity threshold

    Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,

    Measured by microperimetry (MAIA, CenterVue, Italy)

  5. mfERG P1 wave density amplitudes

    Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,

    Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom)

  6. M-score values

    Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

    Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan)

  7. NEI-VFQ-25 questionnaire scores

    Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

    The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire)

Study contacts

Contact information is provided by the study sponsor or research team.

Tian Tian, MD,PhD

CONTACT

[email protected]

+8615216695095

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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