About this trial
Optical coherence tomography (OCT )provides high resolution information regarding the anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view. Much of this information is not able to be visualized by a clinician. Utilizing this information during surgery will allow for the ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.
In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The study population includes any patient requiring ophthalmic surgery
Disqualifiers
Under the age of 18 years.
Cognitive/Mentally impaired or unable to provide consent
Trial population
The study population includes any patient requiring ophthalmic surgery who meets the inclusion criteria for feasibility of OCT imaging.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To assess feasibility of microscope-integrated intraoperative OCT
Feasibility will be assessed as the percentage of cases where OCT images were successfully obtained with a microscope-integrated system
Secondary outcomes
To assess utility of microscope-integrated intraoperative OCT on surgical decision-making
Utility will be assessed through a surgeon-feedback questionnaire, including the percentage of cases where the OCT information changed the surgical approach to the case according to the surgeon.
Sponsors and contacts
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The Cleveland Clinic
Lead sponsor
National Eye Institute (NEI)
Collaborator