PEELED INTERNAL LIMITING MEMBRANE REPOSITION

NCT ID: NCT06359548

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2026-11-30

Brief 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.

Conditions

Macular Holes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Reposition Group

Peeled ILM Reposition

Group Type: EXPERIMENTAL

Peeled ILM Reposition

Intervention Type: 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.

Peeling Group

ILM Peeling

Group Type: ACTIVE_COMPARATOR

ILM Peeling

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

ILM Flap reposition; ILM Flap covering

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tian Tian, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Locations

Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Tian Tian, MD，PhD

Role: CONTACT

tiantianoph@163.com

+8615216695095

Facility Contacts

Tian Tian, Dr.

Role: primary

Other Identifiers

XH-24-002

Identifier Type: -

Identifier Source: org_study_id