iOCT for Patients With Diabetic Macular Edema

June 2, 2024 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group
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 OCT
before and after surgery intraoperative OCT is performed
Device: stand-alone OCT
before and after surgery stand-alone OCT is performed
Sham Comparator: controll group
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 OCT
before and after surgery intraoperative OCT is performed
Device: stand-alone OCT
before and after surgery stand-alone OCT is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
macular thickness
Time Frame: 2 hours
macular thickness is measured with the central subfield thickness function
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, MD, Prof, Vienna Institute for Research in Ocular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMÖ-iOCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Macular Edema

Clinical Trials on intraoperative OCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe