PEELED INTERNAL LIMITING MEMBRANE REPOSITION

NCT06359548 | Recruiting

• 1 other identifier: XH-24-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The MH closure rate

  1-month postoperatively

• The range of inner retinal dimpling

  1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

• Postoperative retinal thickness

  Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

• The fixation stability and sensitivity threshold

  Pre-operatively, 3-month postoperatively, 6-month postoperatively,

• mfERG P1 wave density amplitudes

  Pre-operatively, 3-month postoperatively, 6-month postoperatively,

Study Arms (2)

Reposition Group

EXPERIMENTAL

Peeled ILM Reposition

Procedure: Peeled ILM Reposition

Peeling Group

ACTIVE COMPARATOR

ILM Peeling

Procedure: ILM Peeling

Interventions

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.

Also known as: ILM Flap reposition, ILM Flap covering

Reposition Group

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.

Peeling Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Tian Tian, MD，PhD

  Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Tian, MD，PhD

CONTACT

+8615216695095; tiantianoph@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-01

Locations

CN (1)