Macular Buckle With Three-armed Silicone | NCT02169635

Studies
Macular Buckle With Three-armed Silicone

NCT02169635

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Jun 23, 2014Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

High Myopia
Posterior Staphyloma

Interventions

macular buckle

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jun 17, 2014

First Submission Date that Met QC Criteria

Jun 18, 2014

First Posted Date

Jun 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2014

Last Update Posted Date

Jun 23, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Lu, Director, Fundus Disease Center of Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
macular buckle	Procedure	macular buckle with a three-armed silicone capsule	Macula buckle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
best corrected visual acuity		6 months

Secondary Outcomes

Measure	Description	Time Frame
postoperative complications		6 months
Optical coherence tomography	Using optical coherence tomography to observe the macular area postoperatively.	6 months

Other Outcomes

Measure	Description	Time Frame
intraocular pressure		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lin Lu, MD, PhD	Zhongshan Ophthalmic Center, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center		Guangzhou	Guangdong	510060	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23619638	Background	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. No abstract available.
23190923	Background	Ward B. Degenerative myopia: myopic macular schisis and the posterior pole buckle. Retina. 2013 Jan;33(1):224-31. doi: 10.1097/IAE.0b013e31826d3a93. No abstract available.