Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359548
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-29
Brief Title:
PEELED INTERNAL LIMITING MEMBRANE REPOSITION
Sponsor:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES A Single-centre Randomized Prospective Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None