PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359548
• Other study ID #: XH-24-002
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: November 2026

Study information

• Verified date: January 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Tian Tian, MD,PhD
• Phone: +8615216695095
• Email: tiantianoph[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

1. The patients are diagnosed as MH with a diameter = 600 µm by optical coherence tomography.

2. Age ranges from 50 to 80 years.

3. Do not participate in other clinical studies.

4. Agree to sign an informed consent form with good compliance.

Exclusion Criteria:

1. Traumatic macular hole.

2. Combined with serious epiretinal membrane.

3. Combined with diabetic retinopathy, hypertensive retinopathy.

4. Combined with other ocular diseases, such as keratitis,uveitis,retinal vasculitis.

5. Spherical equivalent = -6.0 diopters or axial length = 26 mm.

6. History of intraocular surgery.

7. Presence of staphyloma.

8. Other ocular diseases that influence macular microstructure or visual function.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Peeled ILM Reposition
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.
• ILM Peeling
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.

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively	The change of BCVA from baseline to 6-month postoperatively	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Secondary	The MH closure rate	The MH closure rate at 1-month postoperatively	1-month postoperatively
Secondary	The range of inner retinal dimpling	The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA)	1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Secondary	Postoperative retinal thickness	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.	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Secondary	The fixation stability and sensitivity threshold	Measured by microperimetry (MAIA, CenterVue, Italy)	Pre-operatively, 3-month postoperatively, 6-month postoperatively,
Secondary	mfERG P1 wave density amplitudes	Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom)	Pre-operatively, 3-month postoperatively, 6-month postoperatively,
Secondary	M-score values	Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan)	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Secondary	NEI-VFQ-25 questionnaire scores	The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire)	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,