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Fourier Transformed Infrared Spectroscopy in Macular Surgery

V

Vienna Institute for Research in Ocular Surgery

Status

Completed

Conditions

Macular Hole
Epiretinal Membrane

Treatments

Device: FTIR spectroscopy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

FTIR arm
Experimental group
Description:
all excised membranes are examined with FTIR spectroscopy
Treatment:
Device: FTIR spectroscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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