Back to resultsAutologous Blood for Full-thickness Macular Hole
Primary Purpose
Ophthalmopathy
Status
Terminated
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Pars-plana vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Ophthalmopathy focused on measuring Full Thickness Macular Hole, Blood Clot, Whole blood, Pars-pana vitrectomy
Eligibility Criteria
Inclusion Criteria:
- Primary and recurrent holes
Exclusion Criteria:
- Lamellar and pseudoholes
Sites / Locations
- Omer Othman Abdullah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Utilizing autologous whole blood for the full thickness macular hole
Arm Description
It is an interventional study by performing pars-plana vitrectomy
Outcomes
Primary Outcome Measures
Anatomical outcome
OCT
Secondary Outcome Measures
Functional outcome
Best corrected visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05494229
Brief Title
Autologous Blood for Full-thickness Macular Hole
Official Title
Autologous Whole Blood for Closing Full-thickness Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to complications
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omer Othman Abdullah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Autologous blood for primary and recurrent holes
Detailed Description
Utilizing whole autologous blood for closing both primary and recurrent holes. Here, we apply a drop of the taken whole blood over the hole, and the access blood will be aspirated on the macula with a silicon-tipped active back-flash cannula, to abolish all the possibilities of the fibrinogenic behavior of the whole blood composition, which might cause traction and recurrent hole formation. Therefore, only the hole will be filled with blood. The blood will be taken under completely sterile and aseptic conditions.
The air infusion will be raised after the valve of one of the trocars will be removed, to allow the air current to dry the clot inside the hole rapidly. Then air gas exchange will be performed to allow the clot to remain away from intraocular fluids for one to two weeks and abolish the possibility of the clot being dissolved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ophthalmopathy
Keywords
Full Thickness Macular Hole, Blood Clot, Whole blood, Pars-pana vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Utilizing autologous whole blood for the full thickness macular hole
Arm Type
Experimental
Arm Description
It is an interventional study by performing pars-plana vitrectomy
Intervention Type
Other
Intervention Name(s)
Pars-plana vitrectomy
Intervention Description
Pars-plana vitrectomy
Primary Outcome Measure Information:
Title
Anatomical outcome
Description
OCT
Time Frame
The fourth week post-operatively
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Best corrected visual acuity
Time Frame
The fourth week post-operatively.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary and recurrent holes
Exclusion Criteria:
Lamellar and pseudoholes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Abdullah, M.Sc.
Organizational Affiliation
Ibinsina Modern Eye and Retina Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omer Othman Abdullah
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Autologous Blood for Full-thickness Macular Hole
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