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NCT04306718 Clinical Trial

Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study

Epiretinal Membrane Clinical Trial

Official title:
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04306718
Other study ID # hya
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 30, 2024

Study information
Verified date June 2024
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Macular hole or epiretinal Membrane Exclusion Criteria: - Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• membrane peeling
ERM and ILM are peeled routinely during surgery

Locations
Country Name City State
Austria VIROS at Hanuschkrankenhaus Vienna

Sponsors (1)
Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Proliferation of Hyalocytes hyalocytes from ERM and ILM will be cultured and counted 9 days
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