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Fourier Transformed Infrared Spectroscopy in Macular Surgery

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ClinicalTrials.gov Identifier: NCT03452748
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief Summary:

Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT).

The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare results to optic coherence tomography (OCT) findings.


Condition or disease Intervention/treatment Phase
Epiretinal Membrane Macular Hole Device: FTIR spectroscopy Not Applicable

Detailed Description:

Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation.

In total, 20 eyes with idiopathic ERM, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic ERM will be examined. To our knowledge there are no previous reports about FTIR spectroscopy of ERM and ILM, therefore the study will be performed as an exploratory pilot study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: all excised membranes will be examined with FTIR spectroscopy, there will be no control group
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Diagnostic
Official Title: Fourier Transformed Infrared Spectroscopy in Macular Surgery
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : October 1, 2019

Arm Intervention/treatment
Experimental: FTIR arm
all excised membranes are examined with FTIR spectroscopy
Device: FTIR spectroscopy
FTIR spectroscopy examines collagen fibers in the excised membranes




Primary Outcome Measures :
  1. collagen [ Time Frame: 3 months ]
    occurrence of different types of collagen fibres in the excised membranes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic ERM, lamellar macular holes, full thickness macular holes, diabetic ERM and the indication for surgery (visual symptoms)
  • Age 21 and older
  • written informed consent for surgery and participation in the study prior to surgery

Exclusion Criteria: - Macular edema due to other reasons than ERM

  • Hereditary macular disorders
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452748


Contacts
Contact: Oliver Findl, Prof. +43 1 91021-84611 oliver@findl.at
Contact: Christoph Leisser, MD +43 1 91021-84611 christoph.leisser@wgkk.at

Locations
Austria
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna Recruiting
Vienna, Austria, 1140
Contact: Oliver Findl, MD, MBA         
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
Principal Investigator: Oliver Findl, Prof. VIROS at Hanuschkrankenhaus

Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of the department of Ophthalmology, principal investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03452748     History of Changes
Other Study ID Numbers: FTIR
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Perforations
Epiretinal Membrane
Retinal Diseases
Eye Diseases