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iOCT for Patients With Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
intraoperative OCT
stand-alone OCT
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Macular Edema

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any relevant corneal disease
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

study group

controll group

Arm Description

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

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

Outcomes

Primary Outcome Measures

macular thickness
macular thickness is measured with the central subfield thickness function

Secondary Outcome Measures

Full Information

First Posted
October 29, 2017
Last Updated
September 15, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT03328715
Brief Title
iOCT for Patients With Diabetic Macular Edema
Official Title
iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT
Detailed Description
48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
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
Arm Title
controll group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
intraoperative OCT
Intervention Description
before and after surgery intraoperative OCT is performed
Intervention Type
Device
Intervention Name(s)
stand-alone OCT
Intervention Description
before and after surgery stand-alone OCT is performed
Primary Outcome Measure Information:
Title
macular thickness
Description
macular thickness is measured with the central subfield thickness function
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Any relevant corneal disease In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, MD, Prof
Email
oliver.findl@wgkk.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, Prof
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No

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iOCT for Patients With Diabetic Macular Edema

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