NCT03372759

Brief Summary

Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract. Epiretinal membranes (ERM) and pseudomaculaforamen are disorders involving the posterior pole of the eyeball with consecutive vision loss. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative use of SD-OCT is possible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
6 months 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
5 months until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

November 8, 2016

Last Update Submit

March 1, 2018

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • postoperative tilt of the IOL is measured with purkinjemetry

    airtamponade has the potential to leave postoperative tilt of the IOL

    3 months

Study Arms (2)

study group air

ACTIVE COMPARATOR

airtamponade

Procedure: airtamponade

study group saline

SHAM COMPARATOR

saline

Procedure: saline

Interventions

airtamponadePROCEDURE

airtamponade is applicated in the study group air

study group air
salinePROCEDURE

saline is left in the study Group saline

study group saline

Eligibility Criteria

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

You may qualify if:

  • patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
  • Minimum Age of 21 years
  • written informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Oliver Findl, Prof

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department of Ophthalmology, principal investigator

Study Record Dates

First Submitted

November 8, 2016

First Posted

December 14, 2017

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

March 5, 2018

Record last verified: 2018-03

Locations

AU(1)