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

NCT ID: NCT02081170

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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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

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Conditions

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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)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous platelet concentrate

Group Type EXPERIMENTAL

Autologous platelet concentrate

Intervention Type PROCEDURE

1. pars plana vitrectomy
2. internal limiting membrane removal
3. Fluid-air exchange
4. Intravitreal autologous platelet concentrate injection
5. Intravitreal gas (14% C3F8) injection
6. Keep prone position for 7-14 days after surgery

Interventions

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Autologous platelet concentrate

1. pars plana vitrectomy
2. internal limiting membrane removal
3. Fluid-air exchange
4. Intravitreal autologous platelet concentrate injection
5. Intravitreal gas (14% C3F8) injection
6. Keep prone position for 7-14 days after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ga Eun Cho, MD

Role: CONTACT

+82-3410-3548

Facility Contacts

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Se Woong Kang, MD

Role: primary

+82-2-3410-3562

Ga Eun Cho, MD

Role: backup

+82-2-3410-3548

Other Identifiers

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2013-12-066

Identifier Type: -

Identifier Source: org_study_id

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