NCT02683694

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

February 12, 2016

Last Update Submit

March 8, 2018

Conditions

Macular Diseases

Keywords

Epiretinal membranelamellar holes of the maculamacular holesvitreomacular traction syndrome

Outcome Measures

Primary Outcomes (1)

  • peeling without staining

    number of patients that could be peeled without use of a dye

    intraoperative (10-15 minutes)

Study Arms (1)

study arm

OTHER

iOCT is performed

Device: iOCT

Interventions

iOCTDEVICE

the number of subjects that can be peeled without dye are assessed

Also known as: intraoperative OCT (iOCT)
study arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Epiretinal MembraneRetinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Oliver Findl, Prof

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Prof. Dr. Oliver Findl, MBA

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 17, 2016

Study Start

February 1, 2015

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

AU(1)