Clinical trial NCT06063005: Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
Official title: Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macular Holes
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
First posted: 2023-10-02
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Secondary outcomes:
measure: Closure rate
timeFrame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai
name: Peiquan Zhao, Dr.
role: STUDY_CHAIR
References: