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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous platelet concentrate
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous platelet concentrate

Arm Description

Outcomes

Primary Outcome Measures

macular hole closure

Secondary Outcome Measures

best-corrected visual acuity
metamorphopsia score
safety outcome
frequency and severity of ocular adverse event

Full Information

First Posted
March 5, 2014
Last Updated
March 6, 2014
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02081170
Brief Title
The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autologous platelet concentrate
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous platelet concentrate
Intervention Description
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
Primary Outcome Measure Information:
Title
macular hole closure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
best-corrected visual acuity
Time Frame
6 months
Title
metamorphopsia score
Time Frame
6 months
Title
safety outcome
Description
frequency and severity of ocular adverse event
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ga Eun Cho, MD
Phone
+82-3410-3548
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
0000
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, MD
Phone
+82-2-3410-3562
First Name & Middle Initial & Last Name & Degree
Ga Eun Cho, MD
Phone
+82-2-3410-3548
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, MD
First Name & Middle Initial & Last Name & Degree
Ga Eun Cho, MD

12. IPD Sharing Statement

Learn more about this trial

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

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