Double Flap Technique for Macular Hole | NCT05269563

Studies
Double Flap Technique for Macular Hole

NCT05269563

Sponsor

Omer Othman Abdullah

Status

Completed

Last Update Posted

Mar 24, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Macular Holes

Interventions

Surgical intervention

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Mar 23, 2023Actual

Completion Date

Mar 23, 2023Actual

First Submitted Date

Jan 28, 2022

First Submission Date that Met QC Criteria

Feb 25, 2022

First Posted Date

Mar 8, 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 24, 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

Double flapping technique to close the macular hole.

Detailed Description

Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.

Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.

Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.

The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Double flap technique to secure macular hole closure.	Experimental	Single ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried.	Other: Surgical intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical intervention	Other	Pars Plana Vitrectomy for Macular Hole Closure	Double flap technique to secure macular hole closure.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular coherence tomography	The closure of the hole can be assessed clearly	The fourth week post-operatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full thickness macular hole

Exclusion Criteria:

Partial-thickness macular hole
Vitreomacular traction

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
Ibinsina Modern eye and retina center		Erbil		44001	Iraq

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided