Macular Buckle With Three-armed Silicone

High Myopia Clinical Trial

— MBTAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169635
• Other study ID #: 2013meky013
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: June 18, 2014
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Myopia
• Myopia
• Posterior Staphyloma

Intervention

Procedure:
• macular buckle
macular buckle with a three-armed silicone capsule

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

Alkabes M, Pichi F, Nucci P, Massaro D, Dutra Medeiros M, Corcostegui B, Mateo C. Anatomical and visual outcomes in high myopic macular hole (HM-MH) without retinal detachment: a review. Graefes Arch Clin Exp Ophthalmol. 2014 Feb;252(2):191-9. doi: 10.1007/s00417-013-2555-5. Epub 2014 Jan 3. Review. — View Citation

Devin F, Tsui I, Morin B, Duprat JP, Hubschman JP. T-shaped scleral buckle for macular detachments in high myopes. Retina. 2011 Jan;31(1):177-80. doi: 10.1097/IAE.0b013e3181fc7e73. — View Citation

Parolini B, Frisina R, Pinackatt S, Mete M. A new L-shaped design of macular buckle to support a posterior staphyloma in high myopia. Retina. 2013 Jul-Aug;33(7):1466-70. doi: 10.1097/IAE.0b013e31828e69ea. — View Citation

Ward B, Tarutta EP, Mayer MJ. The efficacy and safety of posterior pole buckles in the control of progressive high myopia. Eye (Lond). 2009 Dec;23(12):2169-74. doi: 10.1038/eye.2008.433. Epub . — View Citation

Ward B. Degenerative myopia: myopic macular schisis and the posterior pole buckle. Retina. 2013 Jan;33(1):224-31. doi: 10.1097/IAE.0b013e31826d3a93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraocular pressure		6 months	Yes
Primary	best corrected visual acuity		6 months	No
Secondary	postoperative complications		6 months	Yes
Secondary	Optical coherence tomography	Using optical coherence tomography to observe the macular area postoperatively.	6 months	No