Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

Macular Holes Clinical Trial

Official title:

Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063005
• Other study ID #: XH-22-084
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Peiquan Zhao, Dr.
• Phone: 0086 13311620396
• Email: zhaopeiquan[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical trial. This study aims to compare the new surgical approach to the conventional approach in terms of improving visual function, promoting macular retinal anatomical healing, and enhancing patients' quality of life. By conducting this prospective clinical trial, establishing a database, and generating clinical reports and evidence-based medicine on the therapeutic efficacy of the ILM peeling and translocation surgery for large IMH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time.
• Participants diagnosed with idiopathic macular hole (IMH).
• Based on OCT scans, the minimum horizontal diameter of the macular hole is >500 and <900 µm.
• Participants with an axial length <26.0mm and a myopic degree lower than 6D.
• For participants with bilateral macular holes, the eye with a larger hole diameter will be included.

Exclusion Criteria:

• Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment;
• Patients with high myopia (axial length = 26.0mm and myopia exceeding 6D);
• Patients with a history of ocular trauma or retinal laser treatment;
• Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia;
• Patients with contraindications to vitrectomy;
• Patients with severe or unstable systemic diseases;
• Patients with a fasting blood glucose level = 9mmol/L before surgery;
• Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening;
• Patients with a history of intraocular surgery within 3 months prior to screening;
• Patients with reduced visual function or vision in the contralateral eye as determined by the investigator;
• Patients who are not considered suitable for enrollment by the investigator for other reasons.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Translocation ILM Flap
After vitrectomy, the ILM was dissected from the macula to the vascular arch, and the retina in the fissure area was fully released to make an MH-centered, approximately 2DD-square, ILM flap with a tip (approximately 500µm wide) above; the ILM flap was transposed approximately 25-30 degrees along the tip to the inferior temporal area with the assistance of heavy water, and a total of 1ml of perfluorodecalin fluid (heavy water) was injected to cover the MH area with the ILM flap, and the original ILM defect area corresponding to the MH was transposed to the outside of the MH. The heavy water is replaced by liquid/gas exchange. Ophthalmic 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen as the postoperative intraocular filling.
• ILM Peeling
After vitrectomy, internal limiting membrane peeling up to the vascular arcade, thorough loosening of the macular hole area of the retina, and fluid/gas exchange. An eye-specific 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen for intraocular tamponade after the operation.

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity	The best corrected visual acuity indicates the best visual acuity with proper refractive correction.	1 week, 1 month, 3 months, 1 years, 2 years after the operation
Secondary	Closure rate	MH closure is mainly reflected in the outer layer of continuity closure shown on OCT.	1 week, 1 month, 3 months, 1 years, 2 years after the operation