Macular Buckle With Three-armed Silicone

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02169635
Study type	Interventional
Source	Sun Yat-sen University
Contact
Status	Completed
Phase	N/A
Start date	May 2013
Completion date	June 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01658761` - Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes	N/A
Enrolling by invitation	`NCT03666052` - Shanghai Child and Adolescent Large-scale Eye Study -High Myopia Registration
Completed	`NCT03294967` - Effect of Caffeine on Ocular Circulation in High Myopes	N/A
Not yet recruiting	`NCT05550740` - Repeated Low-Level Red-Light Therapy for Shortening Axial Length	N/A
Not yet recruiting	`NCT05095194` - Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT	N/A
Suspended	`NCT02915133` - The Relationship Between Structure and Visual Function in Myopia Foveoschisis
Not yet recruiting	`NCT05533450` - A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens	N/A
Not yet recruiting	`NCT05042856` - To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients	N/A
Completed	`NCT03266354` - Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation
Recruiting	`NCT05201677` - Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract	N/A
Recruiting	`NCT03533647` - Development and Pathological Changes of High Myopia Among Children and Adolescents in China
Completed	`NCT06204211` - Genetic Research on High Myopic Individuals in Northern China
Recruiting	`NCT05691296` - The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin	N/A
Completed	`NCT03202485` - Comparison Between TICL and ICL+AK for High Myopic Astigmatism	N/A
Not yet recruiting	`NCT05768152` - Repeated Low-Level Red-Light Therapy Shortens Axial Length	N/A
Completed	`NCT00564213` - Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds	Phase 4
Active, not recruiting	`NCT05803174` - Screening and Identification of Biomarkers for High Myopia by a Rapid Method
Completed	`NCT03174639` - High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps	N/A
Not yet recruiting	`NCT06264830` - 3D Visualization System in Highly Myopic Cataract Operation	N/A
Recruiting	`NCT05850936` - Effect of IOP Lowering on Progressive HM	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Macular Buckle With Three-armed Silicone — MBTAS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms