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

Not Applicable

Active, not recruiting

• Conditions: Epiretinal Membrane
• Interventions: Procedure: membrane peeling

• Registration Number: NCT04306718
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Macular hole or epiretinal Membrane

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
studyarm	membrane peeling	Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits

Primary Outcome Measures

Name	Time	Method
Proliferation of Hyalocytes	9 days	hyalocytes from ERM and ILM will be cultured and counted

Trial Locations

Locations (1)

VIROS at Hanuschkrankenhaus; 🇦🇹 Vienna, Austria