NCT02319655

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) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM. Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

June 2, 2014

Last Update Submit

October 29, 2017

Conditions

Epiretinal MembraneMacular Pucker

Keywords

Epiretinal membraneMacular puckerMembrane peelingpars plana vitrectomyAirbalanced salt solutionIntraoperative OCTHyporeflectivityRetina

Outcome Measures

Primary Outcomes (1)

  • Proportion of eyes with presence of a hyporeflective zone on the 7th postoperative day on OCT scan

    An expert in the field of reading retinal OCT scans will assess whether or not a hyporeflective zone on the 7th postoperative day is visible on the OCT scan

    7 days postoperatively

Secondary Outcomes (3)

  • Change in retinal thickness 3 months after surgery assessed with OCT

    3 months

  • Attachment of the posterior hyaloid membrane before starting surgery assessed with intraoperative OCT

    intraoperatively

  • Best corrected visual acuity

    3 months postoperatively

Study Arms (2)

Air tamponade

ACTIVE COMPARATOR

Air is injected after vitrectomy/membrane peeling

Procedure: Air tamponade

Balanced salt solution filling

ACTIVE COMPARATOR

Balances salt solution is injected after vitrectomy/membrane peeling

Procedure: Balanced salt solution filling

Interventions

Air tamponadePROCEDURE

Air tamponade

Air tamponade
Balanced salt solution fillingPROCEDURE

BSS filling

Balanced salt solution filling

Eligibility Criteria

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

You may qualify if:

  • Epiretinal membrane and the indication for surgery (visual symptoms)
  • Age 21 and older
  • written informed consent prior to surgery

You may not qualify if:

  • Patients who have already undergone vitrectomy
  • 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)

Oliver Findl

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Oliver Findl, MD,Prof,MBA

    VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prim.Prof.Dr.MBA

Study Record Dates

First Submitted

June 2, 2014

First Posted

December 18, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

AU(1)