Status:
UNKNOWN
Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Shanghai Municipal Science and Technology Commission
Conditions:
Macular Holes
Eligibility:
All Genders
55-70 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06063005
Start Date
July 1 2022
End Date
June 30 2025
Last Update
October 30 2023
Active Locations (1)
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1
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200000