ClinicalTrials.gg
CompletedNCT03452748Updated Sep 29, 2020

Fourier Transformed Infrared Spectroscopy in Macular Surgery

An interventional study of FTIR spectroscopy in Epiretinal Membrane and Macular Hole, sponsored by Vienna Institute for Research in Ocular Surgery. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery — 1 open to participants now, 2 under way, none of them phase 3. Epiretinal Membrane · Vienna Institute for Research in Ocular Surgery.

Started
2017
with 1 other
No phase
8 of 10
1 open now
Registered
3rd of 10
by date

Among the 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery, this one is one of 2 that started in 2017, is one of 8 with no phase, and was the 3rd registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phasethis study8 · 1 open
Observational2 · 0 open

By the year they started

First in 2015; this study’s year is marked. 2 started in 2017.

Size and results

Median enrollment 46 across the 8 interventional studies, 106 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Epiretinal Membrane
  • Macular Hole
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    FTIR arm

    all excised membranes are examined with FTIR spectroscopy

    Device: FTIR spectroscopy

Interventions

  • DeviceFTIR spectroscopy

    FTIR spectroscopy examines collagen fibers in the excised membranes

06

What researchers measure

Primary outcomes

  1. collagen

    occurrence of different types of collagen fibres in the excised membranes

    Time frame: 3 months

07

Study locations

1 site
  • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
    Vienna, 1140, Austria
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jun 2019, 29 months.

Of 30 interventional studies with no phase under Epiretinal Membrane, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 90. This study's 29 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2018
First posted
Mar 2, 2018
StartActual
Jan 1, 2017
Primary completionActual
Jun 1, 2019
CompletionActual
Jun 1, 2019
Last update
Sep 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03452748
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Head of the department of Ophthalmology, principal investigator, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Mar 2, 2018
Start date
Jan 1, 2017
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
Sep 29, 2020

Study contacts

Oliver Findl, Prof.
principal investigator · VIROS at Hanuschkrankenhaus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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