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Active, not recruitingNCT04306718Updated Jun 4, 2024

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

An interventional study of membrane peeling in Epiretinal Membrane, sponsored by Vienna Institute for Research in Ocular Surgery. Active, not recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Epiretinal Membrane

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In context

Epiretinal Membrane

120 studies on the registry are indexed under Epiretinal Membrane; 14 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 73 interventional studies indexed under Epiretinal Membrane.

Browse Epiretinal Membrane studies →

Lead sponsor

Vienna Institute for Research in Ocular Surgery is the lead sponsor of 64 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Macular hole or epiretinal Membrane

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    studyarm

    Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits

    Procedure: membrane peeling

Interventions

  • Proceduremembrane peeling

    ERM and ILM are peeled routinely during surgery

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What researchers measure

Primary outcomes

  1. Proliferation of Hyalocytes

    hyalocytes from ERM and ILM will be cultured and counted

    Time frame: 9 days

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Study locations

1 site
  • VIROS at Hanuschkrankenhaus
    Vienna, 1140, Austria
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References and documents

Publications

  • 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. PubMed 28622372 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04306718
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Head of department, Professor, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Mar 13, 2020
Start date
Oct 1, 2019
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jun 4, 2024

Study contacts

Oliver Findl, Prof., Dr.
principal investigator · VIROS at Hanuschkrankenhaus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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