Macular Buckle With Three-armed Silicone (MBTAS)

Sun Yat-sen University

Status: Completed

Conditions: Posterior Staphyloma; High Myopia

Treatments: Procedure: macular buckle

Study type: Interventional

Funder types: Other

Identifiers

NCT02169635

2013meky013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Macula buckle

Experimental group

Description:

Macular buckle: perform episcleral macular buckle surgery using a three-armed silicone capsule to support the posterior staphyloma in high myopia.

Treatment:

Procedure: macular buckle