Fourier Transformed Infrared Spectroscopy in Macular Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03452748

Enrollment

Registered

2018-03-02

Start date

2017-01-01

Completion date

2019-06-01

Last updated

2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Macular Hole

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.

Interventions

DEVICEFTIR spectroscopy

FTIR spectroscopy examines collagen fibers in the excised membranes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

no masking

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
collagen	3 months	occurrence of different types of collagen fibres in the excised membranes

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026