Eye ManifestationsMIOCTNCT01588041
Intraoperative OCT Guidance of Intraocular Surgery
An observational study of Eye Manifestations, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the use of optical coherence tomography imaging integrated with an operating microscope (MIOCT) in ophthalmic surgeries. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Manifestations
- How many people
- 269 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to 8 Aug 2018
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 722 subjects identified and recruited from the clinics of Duke Eye Center and Cole Eye Institute. Of those, there will be 500 retina subjects and 222 anterior segment subjects. Control subjects may include employees and students of both institutions.
Who may be able to join
- subjects undergoing surgery for vitreoretinal interface disease
- subjects undergoing surgery for macular hole
- subjects undergoing surgery for retinal detachment
- subjects undergoing surgery for diabetic retinopathy with macular edema and/or traction detachments
- subjects undergoing surgery for epiretinal membranes
- subjects undergoing surgery for rare related macular diseases like myopic schisis.
- subjects undergoing endothelial keratoplasty or anterior lamellar keratoplasty
- subjects with normal ocular pathology enrolled as controls
Who cannot join
- 1. Any ocular disease that restricts the ability to perform MIOCT scanning.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cole Eye Institute at the Cleveland Clinic Lemer College of Medicine
Cleveland, Ohio, 44195
Duke University Eye Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to investigate the use of optical coherence tomography imaging integrated with an operating microscope (MIOCT) in ophthalmic surgeries.
Read the detailed description
Optical Coherence Tomography (OCT) is used to capture reproducible ocular morphology and cross-sectional tissue measurements in-vivo in a rapid, non-invasive, non-contact manner. It has displaced ophthalmoscopy and stereo photography for clinical assessment and documentation of retinal microanatomy including thickness, cystoid structures, subretinal fluid and retinal traction.(1) Spectral Domain Optical Coherence Tomography (SDOCT) has the speed and resolution required for real-time noninvasive three-dimensional imaging of critical pathology.
While modern ophthalmic surgery has benefited from rapid advances in instrumentation and techniques (2-6), the basic principles of the stereo zoom operating microscope have not changed (except for increased automation) since the 1930's. (7-9) The ability to better resolve tissue microanatomy through real-time micro-imaging would have a dramatic impact on ophthalmic surgeon's capabilities, foster the development of new surgical techniques, and potentially improve surgical outcomes.
Complementary to microscope integrated OCT (MIOCT) testing, we use a commercial hand-held SDOCT instrument (Bioptigen, Inc.) during pauses in both anterior segment and retinal surgery to document surgical process.
While both the handheld instrument and Duke's Generation 1 (G1) MIOCT prototype have demonstrated that high-quality OCT imaging is possible during surgery, in both cases control of the OCT scan location and display of the real-time image data are managed on the OCT system console, located up to several feet from the surgeon. Thus, the potential dramatic impact of this technology on ophthalmic surgery is constrained by its limited integration with the surgical environment. The primary technical goal of this project is to address this issue through novel advances in OCT technology, automated tracking of surgical instruments and tools, and fusion of OCT controls, images and measurements into a seamless interface for the surgeon.
This study will facilitate future quality improvement processes based on intraoperative data matched to postoperative outcomes. Intraoperative OCT feedback will revolutionize communication in surgical research, clinical communication, surgeon training and continuing education, and will provide measurable data regarding disease patterns and intraoperative response, novel instrument and adjuvant use.
This study will prospectively examine the surgical utility of MIOCT in retinal and anterior segment surgery. A total of 722 subjects will be enrolled at 2 sites, Duke Eye Center and Cole Eye Institute. Of those, there will be 500 retina subjects and 222 anterior segment subjects. There will be a small number of normal subjects, who are not undergoing eye surgery, enrolled in this portion of this study for non-surgical study of the MIOCT system imaging, particularly for Generation 2 (G2) MIOCT. Rate of recruitment: 460 retina subjects will be enrolled at the rate of approximately 115 per year (~57 per year at both Duke and Cole) for years 1-4 and approximately 40 subjects will be enrolled in year 5 (adding up to a total of 500 subjects).
- Conditions
- Eye Manifestations
- Keywords
- Microscope mounted SDOCT
- Medical subject headings
- Eye Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitreoretinal Interface Disease Group | A minimum of 50 subjects with vitreoretinal interface disease will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. | |
| Macular Hole Group | A minimum of 50 subjects with macular hole with be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. | |
| Retinal Detachment Group | A minimum of 50 subjects with retinal detachment will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. | |
| Diabetic Retinopathy Group | A minimum of 50 subjects with diabetic retinopathy will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. | |
| Rare Related Macular Disease Group | Up to 70 subjects with rare related macular diseases will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. | |
| Generation 2 MIOCT Transition Group | 80 of the subjects recruited in years 1 through 5 (40 normal, 40 diseased) will be imaged with both the generation 1 MIOCT and the generation 2 MIOCT systems prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. | |
| Endothelial Keratoplasty Group | 150 subjects undergoing Descemet Stripping Endothelial Keratoplasty (DSEK) will be imaged with MIOCT at the conclusion of the surgical procedure and may be imaged during follow-up visits. | |
| Anterior Lamellar Keratoplasty Group | 150 subjects undergoing Deep Anterior Lamellar Keratoplasty (DALK) will be imaged with MIOCT at the conclusion of the surgical procedure and may be imaged during follow-up visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test and provide feedback on the intraoperative system both in laboratory and then in the operating room.
The primary outcome of this project is to integrate optical coherence tomography (OCT) with the surgical environment through novel advances in OCT technology, automated tracking of surgical instruments and tools, and fusion of OCT controls, images and measurements into a seamless interface for the surgeon.
Measured: 8.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startSep 2009
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Eye ManifestationsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Cynthia A Toth, MD, Principal investigator, Duke University Health System, Department of OphthalmologyJoseph A Izatt, PhD, Principal investigator, Duke University Department of Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588041
- Sponsor's protocol ID
- Pro00016827
- Other IDs
- R01EY023039
- Acronym
- MIOCT
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2012
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All findings resulting from the MIOCT study will be prepared for publication in peer-reviewed journals and posted on PubMed Central once accepted. We are also strong advocates of open-access publishing whenever possible; one of the MPIs (Prof. Izatt) is the founding editor-in-chief of the Optical Society of America's (OSA) newest on-line, open-access journal Biomedical Optics Express (http://www.opticsinfobase.org/boe/home.cfm). We are supportive of efforts by publishers and professional societies to develop technologies for on-line publishing of entire experimental datasets. We have published such datasets using OSA's Interactive Science Publishing technology in the recent past (http://midas.osa.org/midaspub/item/view/1123). We will archive experimental results and findings from the proposed project for at least the duration of the project, and make the underlying datasets available to other researchers upon request.
Publications
Mirza RG, Johnson MW, Jampol LM. Optical coherence tomography use in evaluation of the vitreoretinal interface: a review. Surv Ophthalmol. 2007 Jul-Aug;52(4):397-421. doi: 10.1016/j.survophthal.2007.04.007.
PubMed 17574065Machemer R. The development of pars plana vitrectomy: a personal account. Graefes Arch Clin Exp Ophthalmol. 1995 Aug;233(8):453-68. doi: 10.1007/BF00183425. No abstract available.
PubMed 8537019Tan DT, Mehta JS. Future directions in lamellar corneal transplantation. Cornea. 2007 Oct;26(9 Suppl 1):S21-8. doi: 10.1097/ICO.0b013e31812f685c.
PubMed 17881911Singh MS, MacLaren RE. Stem cells as a therapeutic tool for the blind: biology and future prospects. Proc Biol Sci. 2011 Oct 22;278(1721):3009-16. doi: 10.1098/rspb.2011.1028. Epub 2011 Aug 3.
PubMed 21813553Weiland JD, Cho AK, Humayun MS. Retinal prostheses: current clinical results and future needs. Ophthalmology. 2011 Nov;118(11):2227-37. doi: 10.1016/j.ophtha.2011.08.042.
PubMed 22047893Shin JY, Yu HG. Visual prognosis and spectral-domain optical coherence tomography findings of myopic foveoschisis surgery using 25-gauge transconjunctival sutureless vitrectomy. Retina. 2012 Mar;32(3):486-92. doi: 10.1097/IAE.0b013e31822058d1.
PubMed 21955988Machemer R, Parel JM. An improved microsurgical ceiling-mounted unit and automated television. Am J Ophthalmol. 1978 Feb;85(2):205-9. doi: 10.1016/s0002-9394(14)75949-5.
PubMed 623191Parel JM, Machemer R, Aumayr W. A new concept for vitreous surgery. 5. An automated operating microscope. Am J Ophthalmol. 1974 Feb;77(2):161-8. doi: 10.1016/0002-9394(74)90668-0. No abstract available.
PubMed 4812085Hahn P, Carrasco-Zevallos O, Cunefare D, Migacz J, Farsiu S, Izatt JA, Toth CA. Intrasurgical Human Retinal Imaging With Manual Instrument Tracking Using a Microscope-Integrated Spectral-Domain Optical Coherence Tomography Device. Transl Vis Sci Technol. 2015 Jul 1;4(4):1. doi: 10.1167/tvst.4.4.1. eCollection 2015 Jul.
PubMed 26175961Nam DH, Desouza PJ, Hahn P, Tai V, Sevilla MB, Tran-Viet D, Cunefare D, Farsiu S, Izatt JA, Toth CA. INTRAOPERATIVE SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY IMAGING AFTER INTERNAL LIMITING MEMBRANE PEELING IN IDIOPATHIC EPIRETINAL MEMBRANE WITH CONNECTING STRANDS. Retina. 2015 Aug;35(8):1622-30. doi: 10.1097/IAE.0000000000000534.
PubMed 25829349Kuo AN, Carrasco-Zevallos O, Toth CA, Izatt JA. Caveats to obtaining retinal topography with optical coherence tomography. Invest Ophthalmol Vis Sci. 2014 Sep 11;55(9):5730-1. doi: 10.1167/iovs.14-15212. No abstract available.
PubMed 25213121Folgar FA, Yuan EL, Farsiu S, Toth CA. Lateral and axial measurement differences between spectral-domain optical coherence tomography systems. J Biomed Opt. 2014 Jan;19(1):16014. doi: 10.1117/1.JBO.19.1.016014.
PubMed 24441877Kuo AN, McNabb RP, Chiu SJ, El-Dairi MA, Farsiu S, Toth CA, Izatt JA. Correction of ocular shape in retinal optical coherence tomography and effect on current clinical measures. Am J Ophthalmol. 2013 Aug;156(2):304-11. doi: 10.1016/j.ajo.2013.03.012. Epub 2013 May 6.
PubMed 23659972Hahn P, Migacz J, O'Donnell R, Day S, Lee A, Lin P, Vann R, Kuo A, Fekrat S, Mruthyunjaya P, Postel EA, Izatt JA, Toth CA. Preclinical evaluation and intraoperative human retinal imaging with a high-resolution microscope-integrated spectral domain optical coherence tomography device. Retina. 2013 Jul-Aug;33(7):1328-37. doi: 10.1097/IAE.0b013e3182831293.
PubMed 23538579Ehlers JP, Tao YK, Farsiu S, Maldonado R, Izatt JA, Toth CA. Visualization of real-time intraoperative maneuvers with a microscope-mounted spectral domain optical coherence tomography system. Retina. 2013 Jan;33(1):232-6. doi: 10.1097/IAE.0b013e31826e86f5. No abstract available.
PubMed 23190928
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative OCT Guidance of Intraocular Surgery
- ClinicalTrials.gov ID
- NCT01588041
- Acronym / sponsor ID
- MIOCT / Pro00016827
- Conditions
- Eye Manifestations
- Keywords
- Microscope mounted SDOCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Sep 2009
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 30 Apr 2012 (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.
The purpose of this study is to investigate the use of optical coherence tomography imaging integrated with an operating microscope (MIOCT) in ophthalmic surgeries.
Detailed description
Optical Coherence Tomography (OCT) is used to capture reproducible ocular morphology and cross-sectional tissue measurements in-vivo in a rapid, non-invasive, non-contact manner. It has displaced ophthalmoscopy and stereo photography for clinical assessment and documentation of retinal microanatomy including thickness, cystoid structures, subretinal fluid and retinal traction.(1) Spectral Domain Optical Coherence Tomography (SDOCT) has the speed and resolution required for real-time noninvasive three-dimensional imaging of critical pathology.
While modern ophthalmic surgery has benefited from rapid advances in instrumentation and techniques (2-6), the basic principles of the stereo zoom operating microscope have not changed (except for increased automation) since the 1930's. (7-9) The ability to better resolve tissue microanatomy through real-time micro-imaging would have a dramatic impact on ophthalmic surgeon's capabilities, foster the development of new surgical techniques, and potentially improve surgical outcomes.
Complementary to microscope integrated OCT (MIOCT) testing, we use a commercial hand-held SDOCT instrument (Bioptigen, Inc.) during pauses in both anterior segment and retinal surgery to document surgical process.
While both the handheld instrument and Duke's Generation 1 (G1) MIOCT prototype have demonstrated that high-quality OCT imaging is possible during surgery, in both cases control of the OCT scan location and display of the real-time image data are managed on the OCT system console, located up to several feet from the surgeon. Thus, the potential dramatic impact of this technology on ophthalmic surgery is constrained by its limited integration with the surgical environment. The primary technical goal of this project is to address this issue through novel advances in OCT technology, automated tracking of surgical instruments and tools, and fusion of OCT controls, images and measurements into a seamless interface for the surgeon.
This study will facilitate future quality improvement processes based on intraoperative data matched to postoperative outcomes. Intraoperative OCT feedback will revolutionize communication in surgical research, clinical communication, surgeon training and continuing education, and will provide measurable data regarding disease patterns and intraoperative response, novel instrument and adjuvant use.
This study will prospectively examine the surgical utility of MIOCT in retinal and anterior segment surgery. A total of 722 subjects will be enrolled at 2 sites, Duke Eye Center and Cole Eye Institute. Of those, there will be 500 retina subjects and 222 anterior segment subjects. There will be a small number of normal subjects, who are not undergoing eye surgery, enrolled in this portion of this study for non-surgical study of the MIOCT system imaging, particularly for Generation 2 (G2) MIOCT. Rate of recruitment: 460 retina subjects will be enrolled at the rate of approximately 115 per year (~57 per year at both Duke and Cole) for years 1-4 and approximately 40 subjects will be enrolled in year 5 (adding up to a total of 500 subjects).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Vitreoretinal Interface Disease Group | – | –A minimum of 50 subjects with vitreoretinal interface disease will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. |
| Macular Hole Group | – | –A minimum of 50 subjects with macular hole with be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. |
| Retinal Detachment Group | – | –A minimum of 50 subjects with retinal detachment will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. |
| Diabetic Retinopathy Group | – | –A minimum of 50 subjects with diabetic retinopathy will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. |
| Rare Related Macular Disease Group | – | –Up to 70 subjects with rare related macular diseases will be imaged with MIOCT prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. |
| Generation 2 MIOCT Transition Group | – | –80 of the subjects recruited in years 1 through 5 (40 normal, 40 diseased) will be imaged with both the generation 1 MIOCT and the generation 2 MIOCT systems prior to surgery, during surgical maneuvers, during a normal pause in surgery, and at 2 post-operative follow-up visits. |
| Endothelial Keratoplasty Group | – | –150 subjects undergoing Descemet Stripping Endothelial Keratoplasty (DSEK) will be imaged with MIOCT at the conclusion of the surgical procedure and may be imaged during follow-up visits. |
| Anterior Lamellar Keratoplasty Group | – | –150 subjects undergoing Deep Anterior Lamellar Keratoplasty (DALK) will be imaged with MIOCT at the conclusion of the surgical procedure and may be imaged during follow-up visits. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 722 subjects identified and recruited from the clinics of Duke Eye Center and Cole Eye Institute. Of those, there will be 500 retina subjects and 222 anterior segment subjects. Control subjects may include employees and students of both institutions.
Key inclusion criteria (8 listed)
- subjects undergoing surgery for vitreoretinal interface disease
- subjects undergoing surgery for macular hole
- subjects undergoing surgery for retinal detachment
- subjects undergoing surgery for diabetic retinopathy with macular edema and/or traction detachments
- subjects undergoing surgery for epiretinal membranes
Key exclusion criteria (1 listed)
- 1. Any ocular disease that restricts the ability to perform MIOCT 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
Test and provide feedback on the intraoperative system both in laboratory and then in the operating room.
Time frame: 8.5 years
The primary outcome of this project is to integrate optical coherence tomography (OCT) with the surgical environment through novel advances in OCT technology, automated tracking of surgical instruments and tools, and fusion of OCT controls, images and measurements into a seamless interface for the surgeon.
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 19 Apr 2023.
- Background: PubMed 17574065Mirza RG, Johnson MW, Jampol LM. Optical coherence tomography use in evaluation of the vitreoretinal interface: a review. Surv Ophthalmol. 2007 Jul-Aug;52(4):397-421. doi: 10.1016/j.survophthal.2007.04.007.
- Background: PubMed 8537019Machemer R. The development of pars plana vitrectomy: a personal account. Graefes Arch Clin Exp Ophthalmol. 1995 Aug;233(8):453-68. doi: 10.1007/BF00183425. No abstract available.
- Background: PubMed 17881911Tan DT, Mehta JS. Future directions in lamellar corneal transplantation. Cornea. 2007 Oct;26(9 Suppl 1):S21-8. doi: 10.1097/ICO.0b013e31812f685c.
- Background: PubMed 21813553Singh MS, MacLaren RE. Stem cells as a therapeutic tool for the blind: biology and future prospects. Proc Biol Sci. 2011 Oct 22;278(1721):3009-16. doi: 10.1098/rspb.2011.1028. Epub 2011 Aug 3.
- Background: PubMed 22047893Weiland JD, Cho AK, Humayun MS. Retinal prostheses: current clinical results and future needs. Ophthalmology. 2011 Nov;118(11):2227-37. doi: 10.1016/j.ophtha.2011.08.042.
- Background: PubMed 21955988Shin JY, Yu HG. Visual prognosis and spectral-domain optical coherence tomography findings of myopic foveoschisis surgery using 25-gauge transconjunctival sutureless vitrectomy. Retina. 2012 Mar;32(3):486-92. doi: 10.1097/IAE.0b013e31822058d1.
- Background: PubMed 623191Machemer R, Parel JM. An improved microsurgical ceiling-mounted unit and automated television. Am J Ophthalmol. 1978 Feb;85(2):205-9. doi: 10.1016/s0002-9394(14)75949-5.
- Background: PubMed 4812085Parel JM, Machemer R, Aumayr W. A new concept for vitreous surgery. 5. An automated operating microscope. Am J Ophthalmol. 1974 Feb;77(2):161-8. doi: 10.1016/0002-9394(74)90668-0. No abstract available.
- Background: PubMed 26175961Hahn P, Carrasco-Zevallos O, Cunefare D, Migacz J, Farsiu S, Izatt JA, Toth CA. Intrasurgical Human Retinal Imaging With Manual Instrument Tracking Using a Microscope-Integrated Spectral-Domain Optical Coherence Tomography Device. Transl Vis Sci Technol. 2015 Jul 1;4(4):1. doi: 10.1167/tvst.4.4.1. eCollection 2015 Jul.
- Background: PubMed 25829349Nam DH, Desouza PJ, Hahn P, Tai V, Sevilla MB, Tran-Viet D, Cunefare D, Farsiu S, Izatt JA, Toth CA. INTRAOPERATIVE SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY IMAGING AFTER INTERNAL LIMITING MEMBRANE PEELING IN IDIOPATHIC EPIRETINAL MEMBRANE WITH CONNECTING STRANDS. Retina. 2015 Aug;35(8):1622-30. doi: 10.1097/IAE.0000000000000534.
- Background: PubMed 25213121Kuo AN, Carrasco-Zevallos O, Toth CA, Izatt JA. Caveats to obtaining retinal topography with optical coherence tomography. Invest Ophthalmol Vis Sci. 2014 Sep 11;55(9):5730-1. doi: 10.1167/iovs.14-15212. No abstract available.
- Background: PubMed 24441877Folgar FA, Yuan EL, Farsiu S, Toth CA. Lateral and axial measurement differences between spectral-domain optical coherence tomography systems. J Biomed Opt. 2014 Jan;19(1):16014. doi: 10.1117/1.JBO.19.1.016014.
- Individual participant dataSharing planned: Yes. All findings resulting from the MIOCT study will be prepared for publication in peer-reviewed journals and posted on PubMed Central once accepted. We are also strong advocates of open-access publishing whenever possible; one of the MPIs (Prof. Izatt) is the founding editor-in-chief of the Optical Society of America's (OSA) newest on-line, open-access journal Biomedical Optics Express (http://www.opticsinfobase.org/boe/home.cfm). We are supportive of efforts by publishers and professional societies to develop technologies for on-line publishing of entire experimental datasets. We have published such datasets using OSA's Interactive Science Publishing technology in the recent past (http://midas.osa.org/midaspub/item/view/1123). We will archive experimental results and findings from the proposed project for at least the duration of the project, and make the underlying datasets available to other researchers upon request.
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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.
Cynthia A Toth, MD principal investigator
Duke University Health System, Department of Ophthalmology
Joseph A Izatt, PhD principal investigator
Duke University Department of Biomedical Engineering
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Manifestations, run by Duke University at 2 sites 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 8 inclusion and 1 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Test and provide feedback on the intraoperative system both in laboratory and then in the operating room. (time frame: 8.5 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 NCT01588041, which also lists 39 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 19 Apr 2023.