The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
March 6, 2014 updated by: Samsung Medical Center
The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 0000
- Recruiting
- Samsung Medical Center
-
Contact:
- Se Woong Kang, MD
- Phone Number: +82-2-3410-3562
-
Contact:
- Ga Eun Cho, MD
- Phone Number: +82-2-3410-3548
-
Sub-Investigator:
- Ga Eun Cho, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: autologous platelet concentrate
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
macular hole closure
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
best-corrected visual acuity
Time Frame: 6 months
|
6 months
|
|
|
metamorphopsia score
Time Frame: 6 months
|
6 months
|
|
|
safety outcome
Time Frame: 6 months
|
frequency and severity of ocular adverse event
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
March 5, 2014
First Submitted That Met QC Criteria
March 6, 2014
First Posted (Estimate)
March 7, 2014
Study Record Updates
Last Update Posted (Estimate)
March 7, 2014
Last Update Submitted That Met QC Criteria
March 6, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-12-066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.