iOCT for Patients With Diabetic Macular Edema | NCT03328715

Studies
iOCT for Patients With Diabetic Macular Edema

NCT03328715

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Completed

Last Update Posted

Jun 4, 2024Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Diabetic Macular Edema

Interventions

intraoperative OCT
stand-alone OCT

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Jan 15, 2024Actual

Completion Date

Jan 15, 2024Actual

First Submitted Date

Oct 29, 2017

First Submission Date that Met QC Criteria

Oct 29, 2017

First Posted Date

Nov 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2024

Last Update Posted Date

Jun 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Prof. Dr. Oliver Findl, MBA, Prim, Prof.,, Vienna Institute for Research in Ocular SurgeryPrincipal Investigator

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Active Comparator	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	Device: intraoperative OCT Device: stand-alone OCT
controll group	Sham Comparator	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	Device: intraoperative OCT Device: stand-alone OCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intraoperative OCT	Device	before and after surgery intraoperative OCT is performed	controll group study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Findl, MD, Prof	Vienna Institute for Research in Ocular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna		Vienna		1140	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided