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

• Sponsor: Vienna Institute for Research in Ocular Surgery (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04306718
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Procedure: membrane peeling	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: studyarm Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits	Procedure: membrane peeling; ERM and ILM are peeled routinely during surgery

Outcome Measures

Primary Outcome Measures

1. Proliferation of Hyalocytes [9 days]

   hyalocytes from ERM and ILM will be cultured and counted

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Macular hole or epiretinal Membrane

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIROS at Hanuschkrankenhaus	Vienna		Austria	1140

Sponsors and Collaborators

• Vienna Institute for Research in Ocular Surgery

Investigators

• Principal Investigator: Oliver Findl, Prof., Dr., VIROS at Hanuschkrankenhaus

Study Documents (Full-Text)

None provided.

More Information

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. Review.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of department, Professor, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT04306718
• Other Study ID Numbers: hya
• First Posted: Mar 13, 2020
• Last Update Posted: May 4, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epiretinal Membrane

Study Results

No Results Posted as of May 4, 2021