Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
All Genders
NCT06359548

PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-04-11

90

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Who Can Participate

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with macular hole with diameter ≤ 600 micrometers confirmed by optical coherence tomography
  • Age between 50 and 80 years
  • Not participating in other clinical studies
  • Agree to sign informed consent and have good compliance
Not Eligible

You will not qualify if you...

  • Traumatic macular hole
  • Presence of severe epiretinal membrane
  • Having diabetic retinopathy or hypertensive retinopathy
  • Other eye diseases such as keratitis, uveitis, or retinal vasculitis
  • Spherical equivalent ≤ -6.0 diopters or axial length ≥ 26 mm
  • History of intraocular surgery
  • Presence of staphyloma
  • Other eye diseases affecting macular structure or vision

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School

Shanghai, China

Actively Recruiting

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Research Team

T

Tian Tian, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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