iOCT for Patients With Diabetic Macular Edema

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03328715

Enrollment

Registered

2017-11-01

Start date

2016-12-01

Completion date

2024-01-15

Last updated

2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

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.

Interventions

DEVICEintraoperative OCT

before and after surgery intraoperative OCT is performed

DEVICEstand-alone OCT

before and after surgery stand-alone OCT is performed

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
macular thickness	2 hours	macular thickness is measured with the central subfield thickness function

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026