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Amniotic Membrane for Recurrent Macular Hole

The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03528122
Enrollment
20
Registered
2018-05-17
Start date
2018-02-01
Completion date
2020-05-01
Last updated
2020-02-20

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

Conditions

Macula Hole, Myopic Macular Degeneration, Retinal Detachment

Keywords

amniotic membrane, retinal detachment, Myopic, macular hole, internal limiting membrane

Brief summary

Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.

Detailed description

It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.

Interventions

PROCEDURERecurrent opened macular hole

pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Individuals with recurrent macular hole associated retinal detachment

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included. * Opened holes after 1 month of the surgery. * Myopic macular holes only were included (Refraction of more than \_6 D and/or axial length of more than 26 mm).

Exclusion criteria

* All other causes of macular hole (traumatic and idiopathic) * Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.

Design outcomes

Primary

MeasureTime frameDescription
Anatomical restoration of macular hole closure6 monthsClosure of the macular hole

Secondary

MeasureTime frameDescription
Functional restoration after closure of the macular hole6 monthsImprovement of the best corrected visual acuity (BCVA)

Countries

Egypt

Outcome results

None listed

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