Retinal Detachment Clinical Trial
Official title:
The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
Verified date | February 2020 |
Source | Minia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Minia UNiversity hospital | Minya | Minia |
Lead Sponsor | Collaborator |
---|---|
Minia University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anatomical restoration of macular hole closure | Closure of the macular hole | 6 months | |
Secondary | Functional restoration after closure of the macular hole | Improvement of the best corrected visual acuity (BCVA) | 6 months | |
Secondary | Functional restoration after closure of the macular hole | Any improvement of the waves in the electrophysiological (ERG) study. | 6 months |
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