Macular Buckle With Three-armed Silicone

Not Applicable

Completed

• Conditions: Posterior Staphyloma; High Myopia
• Interventions: Procedure: macular buckle

• Registration Number: NCT02169635
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-05
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-18
• Last Update Submitted: 2014-06-18
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
best corrected visual acuity	6 months

Secondary Outcome Measures

Name	Time	Method
Optical coherence tomography	6 months	Using optical coherence tomography to observe the macular area postoperatively.
postoperative complications	6 months

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China