DISCOVER Study: Microscope-integrated Intraoperative OCT Study

NCT ID: NCT02423213

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinal Diseases Fuchs Endothelial Dystrophy Macular Hole Epiretinal Membrane Retinal Detachment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Justis Ehlers

Assistant Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justis P Ehlers, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Justis P Ehlers, M.D.

Role: CONTACT

216-636-0183

Jamie L Reese, R.N.

Role: CONTACT

216-636-0183

Facility Contacts

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Jamie P Ehlers, MD

Role: primary

216-636-0183

Jamie L Reese, RN

Role: backup

216-636-0183

References

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Ehlers JP, Srivastava SK, Feiler D, Noonan AI, Rollins AM, Tao YK. Integrative advances for OCT-guided ophthalmic surgery and intraoperative OCT: microscope integration, surgical instrumentation, and heads-up display surgeon feedback. PLoS One. 2014 Aug 20;9(8):e105224. doi: 10.1371/journal.pone.0105224. eCollection 2014.

Reference Type BACKGROUND
PMID: 25141340 (View on PubMed)

Ehlers JP, Kaiser PK, Srivastava SK. Intraoperative optical coherence tomography using the RESCAN 700: preliminary results from the DISCOVER study. Br J Ophthalmol. 2014 Oct;98(10):1329-32. doi: 10.1136/bjophthalmol-2014-305294. Epub 2014 Apr 29.

Reference Type BACKGROUND
PMID: 24782469 (View on PubMed)

Other Identifiers

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K23EY022947-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-013

Identifier Type: -

Identifier Source: org_study_id

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