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
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|
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|
|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|
Experimental: FTIR arm
all excised membranes are examined with FTIR spectroscopy
Device: FTIR spectroscopy
FTIR spectroscopy examines collagen fibers in the excised membranes
- collagen [ Time Frame: 3 months ]occurrence of different types of collagen fibres in the excised membranes
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
|Contact: Oliver Findl, Prof.||+43 1 firstname.lastname@example.org|
|Contact: Christoph Leisser, MD||+43 1 email@example.com|
|Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna||Recruiting|
|Vienna, Austria, 1140|
|Contact: Oliver Findl, MD, MBA|
|Principal Investigator:||Oliver Findl, Prof.||VIROS at Hanuschkrankenhaus|