Autologous Blood for Full-thickness Macular Hole

March 23, 2023 updated by: Omer Othman Abdullah

Autologous Whole Blood for Closing Full-thickness Macular Hole

Autologous blood for primary and recurrent holes

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

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 Contact

Study Contact Backup

Study Locations

  • Iraq
      • Erbil, Iraq, 44001
        • Omer Othman Abdullah

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary and recurrent holes

Exclusion Criteria:

  • Lamellar and pseudoholes

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: Utilizing autologous whole blood for the full thickness macular hole
It is an interventional study by performing pars-plana vitrectomy
Other: Pars-plana vitrectomy
Pars-plana vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical outcome
Time Frame: The fourth week post-operatively
OCT
The fourth week post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: The fourth week post-operatively.
Best corrected visual acuity
The fourth week post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omer Othman Abdullah

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 (Actual)

September 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

August 6, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMER 111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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