Fourier Transformed Infrared Spectroscopy in Macular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epiretinal Membrane Macular Hole

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

no masking

Study Groups

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FTIR arm

all excised membranes are examined with FTIR spectroscopy

Group Type EXPERIMENTAL

FTIR spectroscopy

Intervention Type DEVICE

FTIR spectroscopy examines collagen fibers in the excised membranes

Interventions

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FTIR spectroscopy

FTIR spectroscopy examines collagen fibers in the excised membranes

Intervention Type DEVICE

Eligibility Criteria

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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