Skip to content

Single Superior ILM/ERM Flap for the FTMH.

Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05494242
Enrollment
5
Registered
2022-08-09
Start date
2022-09-01
Completion date
2023-03-21
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ophthalmopathy

Keywords

Full thickness macular hole, Epiretinal membrane, Internal limiting membrane, Flap

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.

Detailed description

After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.

Interventions

OTHERSurgical intervention

Pars-plana vitrectomy.

Sponsors

Ibinsina Modern Eye and Retina Center
CollaboratorOTHER
Omer Othman Abdullah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Full thickness macular hole

Exclusion criteria

* Lamellar and pseudo holes

Design outcomes

Primary

MeasureTime frameDescription
Anatomical outcomeThe fourth weeks post-operativelyOCT

Secondary

MeasureTime frameDescription
Functional outcomeThe fourth week post-operatively.Best corrected visual acuity

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026