NCT03328715

Brief Summary

Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 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

December 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

7.1 years

First QC Date

October 29, 2017

Last Update Submit

June 2, 2024

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • macular thickness

    macular thickness is measured with the central subfield thickness function

    2 hours

Study Arms (2)

study group

ACTIVE COMPARATOR

only patients with diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery

Device: intraoperative OCTDevice: stand-alone OCT

controll group

SHAM COMPARATOR

only patients without diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery

Device: intraoperative OCTDevice: stand-alone OCT

Interventions

intraoperative OCTDEVICE

before and after surgery intraoperative OCT is performed

controll groupstudy group
stand-alone OCTDEVICE

before and after surgery stand-alone OCT is performed

controll groupstudy group

Eligibility Criteria

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

You may qualify if:

  • Cataract with the indication for surgery (visual symptoms) for both groups (study and control group)
  • Diabetic macula edema - for the study group
  • Age 21 and older
  • written informed consent prior to surgery

You may not qualify if:

  • Any relevant corneal disease
  • 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

Study Officials

  • Oliver Findl, MD, Prof

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim, Prof.,

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 1, 2017

Study Start

December 1, 2016

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)