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Macular Buckle With Three-armed Silicone (MBTAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02169635
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Information provided by (Responsible Party):
Lin Lu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
High Myopia Posterior Staphyloma Procedure: macular buckle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. best corrected visual acuity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. postoperative complications [ Time Frame: 6 months ]
  2. Optical coherence tomography [ Time Frame: 6 months ]
    Using optical coherence tomography to observe the macular area postoperatively.

Other Outcome Measures:
  1. intraocular pressure [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • high myopia over -8.0 Diopter
  • axial length over 26.5 mm
  • posterior staphyloma

Exclusion Criteria:

  • single eye patients
  • retinal detachment beyond macular area
  • a history of posterior scleritis
  • a history of Glaucoma
  • active hemorrhage in the surgical eye
  • active inflammation in the surgical eye
  • any situation that might hinder the observation of macular

Information from the National Library of Medicine

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 identifier (NCT number): NCT02169635

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China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Lin Lu, MD, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Lin Lu, Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen University Identifier: NCT02169635    
Other Study ID Numbers: 2013meky013
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Lin Lu, Sun Yat-sen University:
macular buckle
high myopia
posterior staphyloma
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases