Autologous Blood for Full-thickness Macular Hole

• Sponsor: Omer Othman Abdullah (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05494229
• Collaborator: (none)
• Enrollment: 5
• Arm: 1
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

Autologous blood for primary and recurrent holes

Condition or Disease	Intervention/Treatment	Phase
Ophthalmopathy	Other: Pars-plana vitrectomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Autologous Whole Blood for Closing Full-thickness Macular Hole
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Anatomical outcome [The fourth week post-operatively]

   OCT

Secondary Outcome Measures

1. Functional outcome [The fourth week post-operatively.]

   Best corrected visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Primary and recurrent holes

Exclusion Criteria:

• Lamellar and pseudoholes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Omer Othman Abdullah

Investigators

• Principal Investigator: Omer Abdullah, M.Sc., Ibinsina Modern Eye and Retina Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina Center
• ClinicalTrials.gov Identifier: NCT05494229
• Other Study ID Numbers: IMER 111
• First Posted: Aug 9, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina Center: Full Thickness Macular Hole; Blood Clot; Whole blood; Pars-pana vitrectomy
• Additional relevant MeSH terms: Retinal Perforations; Eye Diseases

Study Results

No Results Posted as of Aug 15, 2022