Autologous Blood for Full-thickness Macular Hole

Ophthalmopathy Clinical Trial

Official title:

Autologous Whole Blood for Closing Full-thickness Macular Hole

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05494229
• Other study ID #: IMER 111
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Ibinsina Modern Eye and Retina Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Autologous blood for primary and recurrent holes

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary and recurrent holes

Exclusion Criteria:

• Lamellar and pseudoholes

Related Conditions & MeSH terms

• Eye Diseases
• Ophthalmopathy
• Retinal Perforations

Intervention

Other:
• Pars-plana vitrectomy
Pars-plana vitrectomy

Locations

Country	Name	City	State
Iraq	Omer Othman Abdullah	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Omer Othman Abdullah

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical outcome	OCT	The fourth week post-operatively
Secondary	Functional outcome	Best corrected visual acuity	The fourth week post-operatively.