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

Vienna Institute for Research in Ocular Surgery

Status: Active, not recruiting

Conditions: Epiretinal Membrane

Treatments: Procedure: membrane peeling

Study type: Interventional

Funder types: Other

Identifiers

NCT04306718

hya

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Macular hole or epiretinal Membrane

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

studyarm

Experimental group

Description:

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

Treatment:

Procedure: membrane peeling