Retinal DetachmentPIONEERNCT02423161
PIONEER: Intraoperative and Perioperative OCT Study
An observational study of Retinal Detachment and Epiretinal Membrane, run by The Cleveland Clinic at 1 site in United States.
Trial summary
OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized 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 Detachment, Epiretinal Membrane, Macular Hole
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2017
- 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 may be able to join
- The study population includes any patient requiring ophthalmic surgery
Who cannot join
- Children under the age of 18
- Cognitive/Mentally impaired or unable to provide consent
- Media opacity precluding OCT scanning
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: Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study
OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.
Read the detailed description
Over the last decade, optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT has become to function as a light biopsy, allowing clinicians to visualize subtle pathologic changes in the tissue, such as macular edema or subretinal fluid. The use of OCT in the clinic setting has become the standard for monitoring diseases such as macular degeneration and diabetic retinopathy. It has quickly become the most frequent ordered diagnostic test in ophthalmology.
Due to 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-top 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 OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retina in diseases such as retinal detachment, macular hole, and optic pit, that were not previously known. Using OCT during lamellar corneal transplant procedures, anterior segment surgeons have been able to image proper placement of the graft that was previously unattainable with a standard surgical microscopic view.
Using information gained from OCT, surgeons may be able to improve surgical decision making and improve clinical outcomes. For this study, subjects undergoing ophthalmic surgery, including vitreoretinal surgery and anterior segment surgery, would have OCT imaging performed in the perioperative period, intraoperative period, or both to document architectural changes in the ocular tissues. This information would be prospectively collected and reviewed for associations with anatomic and functional outcomes.
A microscope-mounted OCT system will be used to assess feasibility and utility of imaging during ophthalmic surgical milestones.
- Keywords
- OCT, image-guided surgery, vitreoretinal surgery, corneal surgery
- Medical subject headings
- Retinal Detachment, Epiretinal Membrane, Retinal Perforations, Fuchs' Endothelial Dystrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intraoperative OCT
Defined as percentage of cases where OCT was successfully able to be obtained during surgery
Measured: 3 years
Secondary outcomes (3)
Utility of intraoperative OCT
Defined as percentage of cases where the OCT altered surgical decision-making based on surgeon-report on questionnaire
Measured: 3 years
Safety of intraoperative OCT
Defined as the percentage of subjects that experience adverse events that were related to the intraoperative OCT and/or in excess of what might be expected relative to the surgery performed
Measured: 3 years
Time requirements for intraoperative OCT
Defined as the mean number of minutes required to completed intraoperative imaging during a surgical case
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 startAug 2011
- Primary completionAug 2014
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies 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
- 750 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, Cole Eye Institute, Cleveland Clinic, OH 44195
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423161
- Sponsor's protocol ID
- 11-787
- Acronym
- PIONEER
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2015
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Ehlers JP, Ohr MP, Kaiser PK, Srivastava SK. Novel microarchitectural dynamics in rhegmatogenous retinal detachments identified with intraoperative optical coherence tomography. Retina. 2013 Jul-Aug;33(7):1428-34. doi: 10.1097/IAE.0b013e31828396b7.
PubMed 23609120Ehlers JP, Xu D, Kaiser PK, Singh RP, Srivastava SK. Intrasurgical dynamics of macular hole surgery: an assessment of surgery-induced ultrastructural alterations with intraoperative optical coherence tomography. Retina. 2014 Feb;34(2):213-21. doi: 10.1097/IAE.0b013e318297daf3.
PubMed 23860560Ehlers JP, Itoh Y, Xu LT, Kaiser PK, Singh RP, Srivastava SK. Factors associated with persistent subfoveal fluid and complete macular hole closure in the PIONEER study. Invest Ophthalmol Vis Sci. 2014 Dec 18;56(2):1141-6. doi: 10.1167/iovs.14-15765.
PubMed 25525173Ehlers JP, Dupps WJ, Kaiser PK, Goshe J, Singh RP, Petkovsek D, Srivastava SK. The Prospective Intraoperative and Perioperative Ophthalmic ImagiNg with Optical CoherEncE TomogRaphy (PIONEER) Study: 2-year results. Am J Ophthalmol. 2014 Nov;158(5):999-1007. doi: 10.1016/j.ajo.2014.07.034. Epub 2014 Jul 29.
PubMed 25077834Juthani VV, Goshe JM, Srivastava SK, Ehlers JP. Association between transient interface fluid on intraoperative OCT and textural interface opacity after DSAEK surgery in the PIONEER study. Cornea. 2014 Sep;33(9):887-92. doi: 10.1097/ICO.0000000000000209.
PubMed 25055146Au J, Goshe J, Dupps WJ Jr, Srivastava SK, Ehlers JP. Intraoperative Optical Coherence Tomography for Enhanced Depth Visualization in Deep Anterior Lamellar Keratoplasty From the PIONEER Study. Cornea. 2015 Sep;34(9):1039-43. doi: 10.1097/ICO.0000000000000508.
PubMed 26114817
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Intraoperative and Perioperative Ophthalmic Imaging With Optical Coherence Tomography: PIONEER Study
- ClinicalTrials.gov ID
- NCT02423161
- Acronym / sponsor ID
- PIONEER / 11-787
- Keywords
- OCT, image-guided surgery, vitreoretinal surgery, corneal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Aug 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2017 (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.
OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.
Detailed description
Over the last decade, optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT has become to function as a light biopsy, allowing clinicians to visualize subtle pathologic changes in the tissue, such as macular edema or subretinal fluid. The use of OCT in the clinic setting has become the standard for monitoring diseases such as macular degeneration and diabetic retinopathy. It has quickly become the most frequent ordered diagnostic test in ophthalmology.
Due to 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-top 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 OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retina in diseases such as retinal detachment, macular hole, and optic pit, that were not previously known. Using OCT during lamellar corneal transplant procedures, anterior segment surgeons have been able to image proper placement of the graft that was previously unattainable with a standard surgical microscopic view.
Using information gained from OCT, surgeons may be able to improve surgical decision making and improve clinical outcomes. For this study, subjects undergoing ophthalmic surgery, including vitreoretinal surgery and anterior segment surgery, would have OCT imaging performed in the perioperative period, intraoperative period, or both to document architectural changes in the ocular tissues. This information would be prospectively collected and reviewed for associations with anatomic and functional outcomes.
A microscope-mounted OCT system will be used to assess feasibility and utility of imaging during ophthalmic surgical milestones.
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
Key inclusion criteria (1 listed)
- The study population includes any patient requiring ophthalmic surgery
Key exclusion criteria (3 listed)
- Children under the age of 18
- Cognitive/Mentally impaired or unable to provide consent
- Media opacity precluding OCT scanning
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
Feasibility of intraoperative OCT
Time frame: 3 years
Defined as percentage of cases where OCT was successfully able to be obtained during surgery
3 secondary outcomes
Utility of intraoperative OCT
Time frame: 3 years
Safety of intraoperative OCT
Time frame: 3 years
Time requirements for intraoperative OCT
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 20 Aug 2024.
- Background: PubMed 23609120Ehlers JP, Ohr MP, Kaiser PK, Srivastava SK. Novel microarchitectural dynamics in rhegmatogenous retinal detachments identified with intraoperative optical coherence tomography. Retina. 2013 Jul-Aug;33(7):1428-34. doi: 10.1097/IAE.0b013e31828396b7.
- Background: PubMed 23860560Ehlers JP, Xu D, Kaiser PK, Singh RP, Srivastava SK. Intrasurgical dynamics of macular hole surgery: an assessment of surgery-induced ultrastructural alterations with intraoperative optical coherence tomography. Retina. 2014 Feb;34(2):213-21. doi: 10.1097/IAE.0b013e318297daf3.
- Results publication: PubMed 25525173Ehlers JP, Itoh Y, Xu LT, Kaiser PK, Singh RP, Srivastava SK. Factors associated with persistent subfoveal fluid and complete macular hole closure in the PIONEER study. Invest Ophthalmol Vis Sci. 2014 Dec 18;56(2):1141-6. doi: 10.1167/iovs.14-15765.
- Results publication: PubMed 25077834Ehlers JP, Dupps WJ, Kaiser PK, Goshe J, Singh RP, Petkovsek D, Srivastava SK. The Prospective Intraoperative and Perioperative Ophthalmic ImagiNg with Optical CoherEncE TomogRaphy (PIONEER) Study: 2-year results. Am J Ophthalmol. 2014 Nov;158(5):999-1007. doi: 10.1016/j.ajo.2014.07.034. Epub 2014 Jul 29.
- Results publication: PubMed 25055146Juthani VV, Goshe JM, Srivastava SK, Ehlers JP. Association between transient interface fluid on intraoperative OCT and textural interface opacity after DSAEK surgery in the PIONEER study. Cornea. 2014 Sep;33(9):887-92. doi: 10.1097/ICO.0000000000000209.
- Derived from this study: PubMed 26114817Au J, Goshe J, Dupps WJ Jr, Srivastava SK, Ehlers JP. Intraoperative Optical Coherence Tomography for Enhanced Depth Visualization in Deep Anterior Lamellar Keratoplasty From the PIONEER Study. Cornea. 2015 Sep;34(9):1039-43. doi: 10.1097/ICO.0000000000000508.
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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
Cole Eye Institute, Cleveland Clinic, OH 44195
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 Detachment and Epiretinal Membrane, 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 3 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 20 Aug 2024. 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?
Feasibility of 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 NCT02423161, which also lists 6 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 20 Aug 2024.