Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
Primary Purpose
Epiretinal Membrane
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
membrane peeling
Sponsored by
About this trial
This is an interventional basic science trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- Macular hole or epiretinal Membrane
Exclusion Criteria:
- Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Sites / Locations
- VIROS at HanuschkrankenhausRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
studyarm
Arm Description
Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits
Outcomes
Primary Outcome Measures
Proliferation of Hyalocytes
hyalocytes from ERM and ILM will be cultured and counted
Secondary Outcome Measures
Full Information
NCT ID
NCT04306718
First Posted
October 21, 2019
Last Updated
May 1, 2021
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT04306718
Brief Title
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
Official Title
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
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
ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.
Detailed Description
Hyalocytes, typically located 20 to 50μm anterior the internal limiting membrane (ILM), have the potential to contribute to development of epiretinal membranes (ERM) in presence of vitreoschisis. For macular holes, hyalocytes located on the ILM are hypothesized to contribute to the closure of the macular hole after application of the inverted ILM flap technique.
ILM is routinely excised during surgical repair of macular holes. During peeling of ERM it is excised in case of persisting wrinkling of the retinal surface or partial en bloc excision with the ERM. Furthermore, excision of ILM during ERM peeling is associated with significantly lower recurrence rates of ERM and better Long term visual acuity, according to the results reported by Chang et al. Removal of ERM and ILM is part of the surgical routine during surgical repair of macular holes and peeling of epiretinal membranes. Therefore, cultivation of excised ERM and ILM samples does not increase risks for patients in any way. During study it is planned to cultivate hyalocytes for investigation of their role in macular hole closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
studyarm
Arm Type
Experimental
Arm Description
Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits
Intervention Type
Procedure
Intervention Name(s)
membrane peeling
Intervention Description
ERM and ILM are peeled routinely during surgery
Primary Outcome Measure Information:
Title
Proliferation of Hyalocytes
Description
hyalocytes from ERM and ILM will be cultured and counted
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Macular hole or epiretinal Membrane
Exclusion Criteria:
Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, Prof., Dr.
Phone
+43 1 91021-84611
Email
hkh.augen.abt@wgkk.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Leisser, Dr.
Phone
+43 1 91021-84611
Email
hkh.augen.abt@wgkk.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof., Dr.
Organizational Affiliation
VIROS at Hanuschkrankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIROS at Hanuschkrankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof. Dr.
Phone
+43 1 91021-84611
Email
hkh.augen.abt@wgkk.at
First Name & Middle Initial & Last Name & Degree
Christoph Leisser, Dr.
Phone
+43 1 91021-84611
Email
hkh.augen.abt@wgkk.at
12. IPD Sharing Statement
Citations:
PubMed Identifier
28622372
Citation
Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.
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Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
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