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Completed

NCT Number: NCT02169635

Macular Buckle With Three-armed Silicone

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.

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Key information

Conditions

High Myopia Posterior Staphyloma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

macular buckle

Procedure

macular buckle with a three-armed silicone capsule

Primary outcomes

  1. best corrected visual acuity

    Time frame: 6 months

Secondary outcomes

  1. postoperative complications

    Time frame: 6 months

  2. Optical coherence tomography

    Time frame: 6 months

    Using optical coherence tomography to observe the macular area postoperatively.

Other outcomes

  1. intraocular pressure

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: MBTAS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2014
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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