Autologous Blood for Full-thickness Macular Hole

NCT ID: NCT05494229

Last Updated: 2023-03-27

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

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-01

Brief Summary

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Autologous blood for primary and recurrent holes

Detailed Description

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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.

Conditions

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Ophthalmopathy

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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Utilizing autologous whole blood for the full thickness macular hole

It is an interventional study by performing pars-plana vitrectomy

Group Type EXPERIMENTAL

Pars-plana vitrectomy

Intervention Type OTHER

Pars-plana vitrectomy

Interventions

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Pars-plana vitrectomy

Pars-plana vitrectomy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary and recurrent holes

Exclusion Criteria

* Lamellar and pseudoholes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omer Othman Abdullah

OTHER

Sponsor Role lead

Responsible Party

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Omer Othman Abdullah

Associate consultant ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Omer Abdullah, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Ibinsina Modern Eye and Retina Center

Locations

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Omer Othman Abdullah

Erbil, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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IMER 111

Identifier Type: -

Identifier Source: org_study_id

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