Autologous Blood for Full-thickness Macular Hole | NCT05494229

Studies
Autologous Blood for Full-thickness Macular Hole

NCT05494229

Sponsor

Omer Othman Abdullah

Status

Terminated

Last Update Posted

Mar 27, 2023Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Ophthalmopathy

Interventions

Pars-plana vitrectomy

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to complications

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Aug 6, 2022

First Submission Date that Met QC Criteria

Aug 8, 2022

First Posted Date

Aug 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2023

Last Update Posted Date

Mar 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omer Othman Abdullah, Associate consultant ophthalmologist, Ibinsina Modern Eye and Retina CenterSponsor-Investigator

Lead Sponsor

Omer Othman AbdullahOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pars-plana vitrectomy	Other	Pars-plana vitrectomy	Utilizing autologous whole blood for the full thickness macular hole

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary and recurrent holes

Exclusion Criteria:

Lamellar and pseudoholes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer Abdullah, M.Sc.	Ibinsina Modern Eye and Retina Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Omer Othman Abdullah		Erbil		44001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases
D013927	Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided