Human Amniotic Membrane Plug for Large Macular Holes
Primary Purpose
Macular Holes
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
human amniotic membrane plug with vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes focused on measuring Human amniotic membrane; large macular holes
Eligibility Criteria
Inclusion Criteria:
- large macular hole confirmed by optical coherence tomography
Exclusion Criteria:
- patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy
Sites / Locations
- Alexandria university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with large macular holes
Arm Description
Patients suffering from large macular holes as documented by spectral domain OCT will undergo pars plan vitrectomy with human amniotic membrane insertion into the macular hole.
Outcomes
Primary Outcome Measures
closure of the macular hole
closure of the macular hole as shown by optical coherence tomography
Secondary Outcome Measures
Full Information
NCT ID
NCT03917602
First Posted
April 14, 2019
Last Updated
March 23, 2020
Sponsor
University of Alexandria
1. Study Identification
Unique Protocol Identification Number
NCT03917602
Brief Title
Human Amniotic Membrane Plug for Large Macular Holes
Official Title
Human Amniotic Membrane Plug for Large Macular Holes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.
Detailed Description
This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.
Included participants with large macular holes will undergo complete vitrectomy is performed with an accurate vitreal base shaving (Constellation; Alcon Surgical). A human amniotic membrane hAM plug is taken from the hAM patch, and the final dimensions are adjusted with vitreoretinal scissors before insertion into the vitreous. The hAM plug is rolled inside the vitreoretinal forceps and inserted through the trocar into the vitreous. Then the human amniotic membrane is transplanted through macular hole into the subretinal space; it is then spread to cover the entire portion of the hole. Afterward, perfluorocarbon is injected to a complete overfilling of the break to permit good adhesion of the hAM plug to the underlying RPE and the overlying retina. Fluid-air exchange and an endotamponade injection is performed at the end of surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
Human amniotic membrane; large macular holes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with large macular holes
Arm Type
Experimental
Arm Description
Patients suffering from large macular holes as documented by spectral domain OCT will undergo pars plan vitrectomy with human amniotic membrane insertion into the macular hole.
Intervention Type
Procedure
Intervention Name(s)
human amniotic membrane plug with vitrectomy
Other Intervention Name(s)
human amniotic membrane plug with vitrectomy for closure of large macular holes
Intervention Description
using human amniotic membrane plug with vitrectomy to try to close large macular hole
Primary Outcome Measure Information:
Title
closure of the macular hole
Description
closure of the macular hole as shown by optical coherence tomography
Time Frame
at the 6 month follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
large macular hole confirmed by optical coherence tomography
Exclusion Criteria:
patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy
Facility Information:
Facility Name
Alexandria university
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
optical coherence tomography data of patients pre and postoperatively may be shared with other researchers
IPD Sharing Time Frame
after start of recruiting patients
Learn more about this trial
Human Amniotic Membrane Plug for Large Macular Holes
We'll reach out to this number within 24 hrs