Fourier Transformed Infrared Spectroscopy in Macular Surgery

September 28, 2020 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collagen
Time Frame: 3 months
occurrence of different types of collagen fibres in the excised membranes
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vienna Institute for Research in Ocular Surgery

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (ACTUAL)

March 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTIR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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