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NCT03328715 Clinical Trial

iOCT for Patients With Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03328715
Other study ID # DMÖ-iOCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date January 15, 2024

Study information
Verified date June 2024
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date January 15, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• intraoperative OCT
before and after surgery intraoperative OCT is performed
• stand-alone OCT
before and after surgery stand-alone OCT is performed

Locations
Country Name City State
Austria Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary macular thickness macular thickness is measured with the central subfield thickness function 2 hours
See also
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