Macular Buckle With Three-armed Silicone

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy Study of Macular Buckle With A Three-armed Silicone Capsule to Support the Posterior Staphyloma in High Myopia.

Conditions
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High Myopia, Posterior Staphyloma

Intervention / Treatment
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* Procedure: macular buckle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macula buckle<br>Macular buckle: perform episcleral macular buckle surgery using a three-armed silicone capsule to support the posterior staphyloma in high myopia. | Procedure: macular buckle<br>* macular buckle with a three-armed silicone capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications |  | 6 months | 
| Optical coherence tomography | Using optical coherence tomography to observe the macular area postoperatively. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular buckle, high myopia, posterior staphyloma