The Intravitreal Autologous Platelet Concentrate Injectio... | NCT02081170

Studies
The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes

NCT02081170

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Mar 7, 2014Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,
Large Size Macular Hole (Diameter > 600 Microns) or
Recurred or Failed Macular Hole From Previous Surgery
or Chronic Macular Hole (Symptom Duration > 6 Months)

Interventions

Autologous platelet concentrate

Countries

South Korea

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

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 7, 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

Mar 6, 2014

Last Update Posted Date

Mar 7, 2014Estimated

Description Module

Brief Summary

The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.

Detailed Description

Not provided

Conditions Module

Conditions

Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,
Large Size Macular Hole (Diameter > 600 Microns) or
Recurred or Failed Macular Hole From Previous Surgery
or Chronic Macular Hole (Symptom Duration > 6 Months)

Keywords

Not provided

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

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
autologous platelet concentrate	Experimental		Procedure: Autologous platelet concentrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous platelet concentrate	Procedure	pars plana vitrectomy internal limiting membrane removal Fluid-air exchange Intravitreal autologous platelet concentrate injection Intravitreal gas (14% C3F8) injection Keep prone position for 7-14 days after surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
macular hole closure		6 months

Secondary Outcomes

Measure	Description	Time Frame
best-corrected visual acuity		6 months
metamorphopsia score		6 months
safety outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Macular hole with any of following condition
- High myopia (spherical equivalent ≤ -6.0 Diopters)
- Large size macular hole (Diameter > 600 microns)
- Recurred or failed macular hole from previous surgery
- Chronic macular hole (symptom duration > 6 months)

Exclusion Criteria:

Systemic infection
Hematologic disease
Severe maculopathy including severe diabetic retinopathy, advanced age-related macular degeneration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ga Eun Cho, MD	Contact	+82-3410-3548

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Seoul	0000	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms