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Macular Buckle With Three-armed Silicone

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02169635
Acronym
MBTAS
Enrollment
11
Registered
2014-06-23
Start date
2013-05-31
Completion date
2014-06-30
Last updated
2014-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia, Posterior Staphyloma

Keywords

macular buckle, high myopia, posterior staphyloma

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.

Interventions

PROCEDUREmacular buckle

macular buckle with a three-armed silicone capsule

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
best corrected visual acuity6 months

Secondary

MeasureTime frameDescription
postoperative complications6 months
Optical coherence tomography6 monthsUsing optical coherence tomography to observe the macular area postoperatively.

Other

MeasureTime frame
intraocular pressure6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026