Retinal DiseasesDISCOVERNCT02423213
DISCOVER Study: Microscope-integrated Intraoperative OCT Study
An observational study of Retinal Diseases and Fuchs Endothelial Dystrophy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Diseases, Fuchs Endothelial Dystrophy, Macular Hole
- How many people
- 2,911 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes any patient requiring ophthalmic surgery who meets the inclusion criteria for feasibility of OCT imaging.
Who may be able to join
- The study population includes any patient requiring ophthalmic surgery
Who cannot join
- Under the age of 18 years.
- Cognitive/Mentally impaired or unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER 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.
Read the detailed description
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
- Retinal Diseases, Fuchs Endothelial Dystrophy, Macular Hole, Epiretinal Membrane, Retinal Detachment
- Keywords
- OCT, image-guided surgery, ophthalmic surgery
- Medical subject headings
- Retinal Diseases, Fuchs' Endothelial Dystrophy, Retinal Perforations, Epiretinal Membrane, Retinal Detachment
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2026
- Study completionJun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseasesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,911 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Justis Ehlers, The Cleveland Clinic
- Investigators
- Justis P Ehlers, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423213
- Sponsor's protocol ID
- 14-013
- Other IDs
- K23EY022947-01A1
- Acronym
- DISCOVER
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2015
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25141340Ehlers 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.
PubMed 24782469
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery: DISCOVER Study
- ClinicalTrials.gov ID
- NCT02423213
- Acronym / sponsor ID
- DISCOVER / 14-013
- Conditions
- Retinal Diseases, Fuchs Endothelial Dystrophy, Macular Hole, Epiretinal Membrane, Retinal Detachment
- Keywords
- OCT, image-guided surgery, ophthalmic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,911 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2026 (actual)
- Study completion
- Jun 2026 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes any patient requiring ophthalmic surgery who meets the inclusion criteria for feasibility of OCT imaging.
Key inclusion criteria (1 listed)
- The study population includes any patient requiring ophthalmic surgery
Key exclusion criteria (2 listed)
- Under the age of 18 years.
- Cognitive/Mentally impaired or unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To assess utility of microscope-integrated intraoperative OCT on surgical decision-making
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 25141340Ehlers 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.
- Results publication: PubMed 24782469Ehlers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justis P Ehlers, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Diseases and Fuchs Endothelial Dystrophy, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess feasibility of microscope-integrated intraoperative OCT (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.