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OpenTrials
Completed

NCT Number: NCT03328715

iOCT for Patients With Diabetic Macular Edema

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

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Key information

Conditions

Diabetic Macular Edema

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intraoperative OCT

Device

before and after surgery intraoperative OCT is performed

stand-alone OCT

Device

before and after surgery stand-alone OCT is performed

Primary outcomes

  1. macular thickness

    Time frame: 2 hours

    macular thickness is measured with the central subfield thickness function

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2017
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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