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Search / Trial NCT06685328

Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH

Launched by JIE ZHONG · Nov 11, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Macular Hole Inner Limiting Membrane Flap Sodium Hyaluronate Gel Minimal Posterior Pole Vitrectomy

ClinConnect Summary

Macular hole is a tissue defect that occurs from the inner limiting membrane of the retina to the photoreceptor layer in the macula, severely compromising the patient's central vision. Currently, the standard of care for macular holes is complete vitrectomy combined with stripping, plugging, or flipping of the inner limiting membrane to cover the macular hole, followed by tamponade with prolonged gas or filtered air. After surgery, patients are usually required to remain in a supine position for days to weeks, which is extremely stressful. Despite the effectiveness of current methods, there...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients diagnosed with idiopathic macular hole and 250 μm ≤ aperture size ≤ 800 μm, with clinical diagnosis based on visual acuity testing, fundus photography, and swept optical coherence tomography/optical coherence tomography angiography (SS-OCT/OCTA)
  • Age ≥18 years, gender not restricted
  • 22 mm ≤ eye axis ≤ 26 mm
  • Patients who can cooperate with accurate microperimetry testing
  • Individuals who are able to follow up at the time specified by the researcher
  • Exclusion Criteria:
  • Coexisting active eyelid or appendage infections
  • Coexisting ocular pathology other than cataract that affects vision (e.g., retinal detachment or proliferative vitreoretinopathy; diabetic retinopathy; retinal vascular occlusion; uveitis; ocular tumors; glaucoma)
  • patients who refused to be randomized
  • Other relevant medical history such as cranial brain disease, systemic immune system disease, etc.
  • Those who have received medical or surgical treatment other than myopia and cataract in the study eye within the previous 12 months
  • Other patients who, in the opinion of the investigator, should be excluded.

About Jie Zhong

Jie Zhong is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a commitment to rigorous scientific standards and ethical practices, Jie Zhong collaborates with leading research institutions and healthcare professionals to design, implement, and oversee clinical trials across various therapeutic areas. The organization emphasizes patient safety and data integrity, striving to contribute valuable insights that can lead to new treatment options and enhance the understanding of complex health conditions. Through its strategic partnerships and commitment to excellence, Jie Zhong aims to drive meaningful advancements in healthcare.

Locations

Chengdu, Sichuan, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported