iOCT for Patients With Diabetic Macular Edema

NCT ID: NCT03328715

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2024-01-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

intraoperative OCT

Intervention Type DEVICE

before and after surgery intraoperative OCT is performed

stand-alone OCT

Intervention Type DEVICE

before and after surgery stand-alone OCT is performed

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

Group Type SHAM_COMPARATOR

intraoperative OCT

Intervention Type DEVICE

before and after surgery intraoperative OCT is performed

stand-alone OCT

Intervention Type DEVICE

before and after surgery stand-alone OCT is performed

Interventions

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intraoperative OCT

before and after surgery intraoperative OCT is performed

Intervention Type DEVICE

stand-alone OCT

before and after surgery stand-alone OCT is performed

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Prim, Prof.,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

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

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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DMÖ-iOCT

Identifier Type: -

Identifier Source: org_study_id

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