iOCT for Patients With Diabetic Macular Edema

Vienna Institute for Research in Ocular Surgery

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Device: intraoperative OCT; Device: stand-alone OCT

Study type: Interventional

Funder types: Other

Identifiers

NCT03328715

DMÖ-iOCT

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

study group

Active Comparator group

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

Treatment:

Device: stand-alone OCT

Device: intraoperative OCT

controll group

Sham Comparator group

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

Treatment:

Device: stand-alone OCT

Device: intraoperative OCT