Macular Buckle With Three-armed Silicone (MBTAS)
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|ClinicalTrials.gov Identifier: NCT02169635|
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|High Myopia Posterior Staphyloma||Procedure: macular buckle||Not Applicable|
- 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;
- The macular buckle device, surgical procedure, and participants registry had been reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;
- Only those patients are diagnosed with severe posterior staphyloma are registered.
- All participants are fully informed before register;
- All the surgeries are performed by single qualified doctor (Lin Lu);
- 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;
- Specially assigned staff (Jinge Lu) is responsible for data collection, data management, adverse events reporting, and participant communication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Macular Buckle With A Three-armed Silicone Capsule to Support the Posterior Staphyloma in High Myopia.|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Macula buckle
Macular buckle: perform episcleral macular buckle surgery using a three-armed silicone capsule to support the posterior staphyloma in high myopia.
Procedure: macular buckle
macular buckle with a three-armed silicone capsule
- best corrected visual acuity [ Time Frame: 6 months ]
- postoperative complications [ Time Frame: 6 months ]
- Optical coherence tomography [ Time Frame: 6 months ]Using optical coherence tomography to observe the macular area postoperatively.
- intraocular pressure [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169635
|Zhongshan Ophthalmic Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Lin Lu, MD, PhD||Zhongshan Ophthalmic Center, Sun Yat-sen University|