NCT03452748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

February 22, 2018

Last Update Submit

September 28, 2020

Conditions

Epiretinal MembraneMacular Hole

Outcome Measures

Primary Outcomes (1)

  • collagen

    occurrence of different types of collagen fibres in the excised membranes

    3 months

Study Arms (1)

FTIR arm

EXPERIMENTAL

all excised membranes are examined with FTIR spectroscopy

Device: FTIR spectroscopy

Interventions

FTIR spectroscopyDEVICE

FTIR spectroscopy examines collagen fibers in the excised membranes

FTIR arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hereditary macular disorders
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Epiretinal MembraneRetinal Perforations

Interventions

Spectroscopy, Fourier Transform Infrared

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Spectrophotometry, InfraredSpectrophotometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • Oliver Findl, Prof.

    VIROS at Hanuschkrankenhaus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
no masking
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: all excised membranes will be examined with FTIR spectroscopy, there will be no control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department of Ophthalmology, principal investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 2, 2018

Study Start

January 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

AU(1)