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Fourier Transformed Infrared Spectroscopy in Macular Surgery

Primary Purpose

Epiretinal Membrane, Macular Hole

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
FTIR spectroscopy
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epiretinal Membrane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FTIR arm

Arm Description

all excised membranes are examined with FTIR spectroscopy

Outcomes

Primary Outcome Measures

collagen
occurrence of different types of collagen fibres in the excised membranes

Secondary Outcome Measures

Full Information

First Posted
February 22, 2018
Last Updated
September 28, 2020
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT03452748
Brief Title
Fourier Transformed Infrared Spectroscopy in Macular Surgery
Official Title
Fourier Transformed Infrared Spectroscopy in Macular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Macular Hole

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FTIR arm
Arm Type
Experimental
Arm Description
all excised membranes are examined with FTIR spectroscopy
Intervention Type
Device
Intervention Name(s)
FTIR spectroscopy
Intervention Description
FTIR spectroscopy examines collagen fibers in the excised membranes
Primary Outcome Measure Information:
Title
collagen
Description
occurrence of different types of collagen fibres in the excised membranes
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof.
Organizational Affiliation
VIROS at Hanuschkrankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

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Fourier Transformed Infrared Spectroscopy in Macular Surgery

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