Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02169635
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2014-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macular Buckle With Three-armed Silicone
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Safety and Efficacy Study of Macular Buckle With A Three-armed Silicone Capsule to Support the Posterior Staphyloma in High Myopia.
Status:
COMPLETED
Status Verified Date:
2014-06
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:
MBTAS
Brief Summary:
High myopia is characterized by prolonged axial length and posterior staphyloma, which result in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to anatomical improvements, but an higher axial length and the presence of a sever posterior staphyloma remains to be the two most important risk factors for poor visual outcomes. For these reasons, a different surgical approach, including macular buckling, might be considered in those patients with extremely high degree of myopia, in order to counteract the traction exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy had been proved to be an effective way to resolve myopic staphyloma related foveoschisis, macular hole, and associated retinal detachment. In this study, we sought to investigate the safety and efficacy of a macular buckling technique using a three-armed silicone capsule to support the posterior staphyloma in high myopia.
Detailed Description:
1. This study plans to recruit 11 participants with 6 months follow-up to assess the safety and efficacy of a newly designed macular buckle device;
2. The macular buckle device, surgical procedure, and participants registry had been reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;
3. Only those patients are diagnosed with severe posterior staphyloma are registered.
4. All participants are fully informed before register;
5. All the surgeries are performed by single qualified doctor (Lin Lu);
6. After operation, all participant could contact the researcher via telephone, and could be assessed for any surgical related complications. If there is severe complication happened, or any person that could not tolerant the macular buckle, the implanted device will be removed;
7. Specially assigned staff (Jinge Lu) is responsible for data collection, data management, adverse events reporting, and participant communication.
2. The macular buckle device, surgical procedure, and participants registry had been reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;
3. Only those patients are diagnosed with severe posterior staphyloma are registered.
4. All participants are fully informed before register;
5. All the surgeries are performed by single qualified doctor (Lin Lu);
6. After operation, all participant could contact the researcher via telephone, and could be assessed for any surgical related complications. If there is severe complication happened, or any person that could not tolerant the macular buckle, the implanted device will be removed;
7. Specially assigned staff (Jinge Lu) is responsible for data collection, data management, adverse events reporting, and participant communication.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: