4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The study team will conduct the first in-human pilot studies using 4D MIOCT for imaging in the operating room. Building on the earlier integration and wet-lab validations, the researchers will assess the system's ease of use, safety, and visualization of intended structures during various anterior and posterior segment ophthalmic procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult participants 18 years of age and older
Patients undergoing surgery for ocular disease
Adults able and willing to give informed consent to participate in the study
Disqualifiers
Patients with any ocular disease that restricts the ability to perform OCT scanning
Trial design
Design model
Single group
Treatments tested in this trial
4D MIOCT integrated into a Zeiss Artevo 800
Device4D MIOCT integrated into a Zeiss Artevo 800 surgical microscope with an add-on investigational 3D OCT scanner
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Group 1 - Imaging during ophthalmic surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
4D MIOCT ease of use
Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)
Time frame
Standard of care visit - day 1Secondary outcomes
1
Surgical workflow
Evaluation of surgical workflow/interference using Likert Scales (Likert scores 1-5)
Time frame
Standard of care visit - day 12
Presence of microanatomy as measured by 4D MIOCT image reading
Presence (Yes/No) of retinal anatomy as measured from 4D MIOCT grading
Time frame
Standard of care visit - day 13
Presence of abnormal microanatomy as measured by 4D MIOCT
Combination of presence (Yes/No) and severity (e.g. mild, moderate, severe) of abnormal retinal structures and measured from 4D MIOCT images
Time frame
Standard of care visit - day 1Sponsors and contacts
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Duke University
Lead sponsor
Carl Zeiss Meditec AG
Collaborator
Source ClinicalTrials.gov