iOCT for Patients With Diabetic Macular Edema

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Device: intraoperative OCT; Device: stand-alone OCT

• Registration Number: NCT03328715
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-10-29
• Study First Posted: 2017-11-01
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controll group	stand-alone OCT	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
study group	stand-alone OCT	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
study group	intraoperative OCT	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
controll group	intraoperative OCT	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

Primary Outcome Measures

Name	Time	Method
macular thickness	2 hours	macular thickness is measured with the central subfield thickness function

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna; 🇦🇹 Vienna, Austria