NCT05269563

Brief Summary

Double flapping technique to close the macular hole.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

January 28, 2022

Last Update Submit

March 23, 2023

Conditions

Macular Holes

Keywords

Double Flaps

Outcome Measures

Primary Outcomes (1)

  • Ocular coherence tomography

    The closure of the hole can be assessed clearly

    The fourth week post-operatively

Study Arms (1)

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

Surgical interventionOTHER

Pars Plana Vitrectomy for Macular Hole Closure

Double flap technique to secure macular hole closure.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Full thickness macular hole

You may not qualify if:

  • Partial-thickness macular hole
  • Vitreomacular traction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibinsina Modern eye and retina center

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Omer Abdullah, M.Sc.

    Ibinsina Modern Eye and Retina Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate consultant ophthalmologist

Study Record Dates

First Submitted

January 28, 2022

First Posted

March 8, 2022

Study Start

January 1, 2022

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

IR(1)