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NCT Number: NCT02423213

DISCOVER Study: Microscope-integrated Intraoperative OCT Study

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.

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Key information

Conditions

Retinal Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Epiretinal Membrane Eye Diseases Eye Diseases, Hereditary Fuchs Endothelial Dystrophy Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Macular Hole Retinal Detachment Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to the ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT functions almost like a light biopsy, allowing clinicians to visualize subtle changes in the tissue, such as macular edema or subretinal fluid. OCT in the clinic setting has become the gold standard for monitoring diseases such as macular degeneration and diabetic retinopathy;and it has become one of the most frequently ordered diagnostic test in ophthalmology.

Due to the restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-tops models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from the OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retinal diseases such as retinal detachment, macular hole and optic pit, that were not previously known. Our research team has been examining intraoperative OCT in the operating room using both a handheld and microscope-mounted portable spectral domain OCT probe with excellent success and an outstanding safety record.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study population includes any patient requiring ophthalmic surgery

Exclusion criteria

  • Under the age of 18 years.
  • Cognitive/Mentally impaired or unable to provide consent

Treatment and study plan

Primary outcomes

  1. To assess feasibility of microscope-integrated intraoperative OCT

    Time frame: 3 years

    Feasibility will be assessed as the percentage of cases where OCT images were successfully obtained with a microscope-integrated system

Secondary outcomes

  1. To assess utility of microscope-integrated intraoperative OCT on surgical decision-making

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie L Reese, R.N.

CONTACT

[email protected]

216-636-0183

Justis P Ehlers, M.D.

CONTACT

[email protected]

216-636-0183

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER Study

Acronym: DISCOVER

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2015
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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