Fourier Transformed Infrared Spectroscopy in Macular Surgery

Sponsor

Vienna Institute for Research in Ocular Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT03452748

Collaborator

(none)

Enrollment

Location

Arm

28.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane Macular Hole	Device: FTIR spectroscopy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

all excised membranes will be examined with FTIR spectroscopy, there will be no control groupall 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 :

Jan 1, 2017

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

collagen [3 months]
occurrence of different types of collagen fibres in the excised membranes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna		Austria	1140

Sponsors and Collaborators

Vienna Institute for Research in Ocular Surgery

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

FTIR

First Posted:

Mar 2, 2018

Last Update Posted:

Sep 29, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Perforations

Epiretinal Membrane

Study Results

No Results Posted as of Sep 29, 2020