Human Amniotic Membrane Plug for Large Macular Holes
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| ClinicalTrials.gov Identifier: NCT03917602 |
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Recruitment Status :
Completed
First Posted : April 17, 2019
Last Update Posted : March 24, 2020
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Sponsor:
University of Alexandria
Information provided by (Responsible Party):
Mahmoud Abouhussein, University of Alexandria
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | April 14, 2019 | ||||||||
| First Posted Date ICMJE | April 17, 2019 | ||||||||
| Last Update Posted Date | March 24, 2020 | ||||||||
| Actual Study Start Date ICMJE | May 11, 2019 | ||||||||
| Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
closure of the macular hole [ Time Frame: at the 6 month follow up visit ] closure of the macular hole as shown by optical coherence tomography
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Human Amniotic Membrane Plug for Large Macular Holes | ||||||||
| Official Title ICMJE | Human Amniotic Membrane Plug for Large Macular Holes | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Macular Holes | ||||||||
| Intervention ICMJE | Procedure: human amniotic membrane plug with vitrectomy
using human amniotic membrane plug with vitrectomy to try to close large macular hole
Other Name: human amniotic membrane plug with vitrectomy for closure of large macular holes
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| Study Arms ICMJE | Experimental: Patients with large macular holes
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: Procedure: human amniotic membrane plug with vitrectomy
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Actual Enrollment ICMJE |
15 | ||||||||
| Original Estimated Enrollment ICMJE |
10 | ||||||||
| Actual Study Completion Date ICMJE | January 31, 2020 | ||||||||
| Actual Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 5 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | Egypt | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03917602 | ||||||||
| Other Study ID Numbers ICMJE | 12042019 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Mahmoud Abouhussein, University of Alexandria | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | University of Alexandria | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of Alexandria | ||||||||
| Verification Date | March 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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