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出境医 / 临床实验 / Human Amniotic Membrane Plug for Large Macular Holes

Human Amniotic Membrane Plug for Large Macular Holes

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.

Condition or disease Intervention/treatment Phase
Macular Holes Procedure: human amniotic membrane plug with vitrectomy Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Amniotic Membrane Plug for Large Macular Holes
Actual Study Start Date : May 11, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 31, 2020
Arms and Interventions
Arm Intervention/treatment
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.
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

Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Egypt
Alexandria university
Alexandria, Egypt
Sponsors and Collaborators
University of Alexandria
Tracking Information
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
 (submitted: April 14, 2019)
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
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.

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
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
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2019)
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:

  • large macular hole confirmed by optical coherence tomography

Exclusion Criteria:

  • patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: optical coherence tomography data of patients pre and postoperatively may be shared with other researchers
Supporting Materials: Study Protocol
Time Frame: after start of recruiting patients
Responsible Party Mahmoud Abouhussein, University of Alexandria
Study Sponsor  ICMJE University of Alexandria
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alexandria
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP