NCT05494242

Brief Summary

In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

August 6, 2022

Last Update Submit

March 23, 2023

Conditions

Ophthalmopathy

Keywords

Full thickness macular holeEpiretinal membraneInternal limiting membraneFlap

Outcome Measures

Primary Outcomes (1)

  • Anatomical outcome

    OCT

    The fourth weeks post-operatively

Secondary Outcomes (1)

  • Functional outcome

    The fourth week post-operatively.

Study Arms (2)

single superior flap technique to secure macular hole closure.

EXPERIMENTAL

The patients are divided into two groups: For the first group, the flap will be carried out under the effect of perfluorocarbon. For the second group, the flap stabilized with methylcellulose.

Other: Surgical intervention

Double flap technique to secure macular hole closure.

ACTIVE COMPARATOR

This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique.

Other: Surgical intervention

Interventions

Surgical interventionOTHER

Pars-plana vitrectomy.

Double flap technique to secure macular hole closure.single superior flap technique to secure macular hole closure.

Eligibility Criteria

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

You may qualify if:

  • Full thickness macular hole

You may not qualify if:

  • Lamellar and pseudo holes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omer Othman Abdullah

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Eye DiseasesEpiretinal Membrane

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Retinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate consultant ophthalmologist

Study Record Dates

First Submitted

August 6, 2022

First Posted

August 9, 2022

Study Start

September 1, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Both the best corrected visual acuity and the OCT.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Expected to be available around the end of November 2022
Access Criteria
via your permisson

Locations

IR(1)