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Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases

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ClinicalTrials.gov Identifier: NCT02683694
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief Summary:

During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula.

Epiretinal membrane (ERM), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.

Different study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.


Condition or disease Intervention/treatment Phase
Macular Diseases Device: iOCT Not Applicable

Detailed Description:
The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases
Study Start Date : February 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
study arm
iOCT is performed
Device: iOCT
the number of subjects that can be peeled without dye are assessed
Other Name: intraoperative OCT (iOCT)




Primary Outcome Measures :
  1. peeling without staining [ Time Frame: intraoperative (10-15 minutes) ]
    number of patients that could be peeled without use of a dye



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epiretinal Membrane, lamellar hole of the macula, macular hole and vitreomacular traction syndrome

Exclusion Criteria:

  • Other diseases of the eye, such as AMD, retinopathia pigmentosa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683694


Locations
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Austria
VIROS
Vienna, Austria, 1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
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Principal Investigator: Oliver Findl, Prof Vienna Institute for Research in Ocular Surgery

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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT02683694     History of Changes
Other Study ID Numbers: iOC
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
Epiretinal membrane
lamellar holes of the macula
macular holes
vitreomacular traction syndrome