Eye Manifestations Clinical Trial
— MIOCTOfficial title:
Intraoperative OCT Guidance of Intraocular Surgery
Verified date | April 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to investigate the use of optical coherence tomography imaging integrated with an operating microscope (MIOCT) in ophthalmic surgeries.
Status | Completed |
Enrollment | 269 |
Est. completion date | August 8, 2018 |
Est. primary completion date | August 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Years and older |
Eligibility | Inclusion criteria 1. subjects undergoing surgery for vitreoretinal interface disease 2. subjects undergoing surgery for macular hole 3. subjects undergoing surgery for retinal detachment 4. subjects undergoing surgery for diabetic retinopathy with macular edema and/or traction detachments 5. subjects undergoing surgery for epiretinal membranes 6. subjects undergoing surgery for rare related macular diseases like myopic schisis. 7. subjects undergoing endothelial keratoplasty or anterior lamellar keratoplasty 8. subjects with normal ocular pathology enrolled as controls Exclusion criteria: 1. Any ocular disease that restricts the ability to perform MIOCT scanning. |
Country | Name | City | State |
---|---|---|---|
United States | Cole Eye Institute at the Cleveland Clinic Lemer College of Medicine | Cleveland | Ohio |
United States | Duke University Eye Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Eye Institute (NEI) |
United States,
Bhullar PK, Carrasco-Zevallos OM, Dandridge A, Pasricha ND, Keller B, Shen L, Izatt JA, Toth CA, Kuo AN. Intraocular Pressure and Big Bubble Diameter in Deep Anterior Lamellar Keratoplasty: An Ex-Vivo Microscope-Integrated OCT With Heads-Up Display Study. Asia Pac J Ophthalmol (Phila). 2017 Sep-Oct;6(5):412-417. doi: 10.22608/APO.2017265. — View Citation
Bleicher ID, Jackson-Atogi M, Viehland C, Gabr H, Izatt JA, Toth CA. Depth-Based, Motion-Stabilized Colorization of Microscope-Integrated Optical Coherence Tomography Volumes for Microscope-Independent Microsurgery. Transl Vis Sci Technol. 2018 Nov 1;7(6):1. doi: 10.1167/tvst.7.6.1. eCollection 2018 Nov. — View Citation
Carrasco-Zevallos OM, Keller B, Viehland C, Shen L, Seider MI, Izatt JA, Toth CA. Optical Coherence Tomography for Retinal Surgery: Perioperative Analysis to Real-Time Four-Dimensional Image-Guided Surgery. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT37-50. doi: 10.1167/iovs.16-19277. — View Citation
Carrasco-Zevallos OM, Keller B, Viehland C, Shen L, Waterman G, Todorich B, Shieh C, Hahn P, Farsiu S, Kuo AN, Toth CA, Izatt JA. Live volumetric (4D) visualization and guidance of in vivo human ophthalmic surgery with intraoperative optical coherence tomography. Sci Rep. 2016 Aug 19;6:31689. doi: 10.1038/srep31689. — View Citation
Carrasco-Zevallos OM, Viehland C, Keller B, Draelos M, Kuo AN, Toth CA, Izatt JA. Review of intraoperative optical coherence tomography: technology and applications [Invited]. Biomed Opt Express. 2017 Feb 21;8(3):1607-1637. doi: 10.1364/BOE.8.001607. eCollection 2017 Mar 1. — View Citation
Chen X, Viehland C, Carrasco-Zevallos OM, Keller B, Vajzovic L, Izatt JA, Toth CA. Microscope-Integrated Optical Coherence Tomography Angiography in the Operating Room in Young Children With Retinal Vascular Disease. JAMA Ophthalmol. 2017 May 1;135(5):483-486. doi: 10.1001/jamaophthalmol.2017.0422. — View Citation
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Ehlers JP, Kernstine K, Farsiu S, Sarin N, Maldonado R, Toth CA. Analysis of pars plana vitrectomy for optic pit-related maculopathy with intraoperative optical coherence tomography: a possible connection with the vitreous cavity. Arch Ophthalmol. 2011 Nov;129(11):1483-6. doi: 10.1001/archophthalmol.2011.316. — View Citation
Ehlers JP, Tao YK, Farsiu S, Maldonado R, Izatt JA, Toth CA. Integration of a spectral domain optical coherence tomography system into a surgical microscope for intraoperative imaging. Invest Ophthalmol Vis Sci. 2011 May 16;52(6):3153-9. doi: 10.1167/iovs.10-6720. — View Citation
Ehlers 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. — View Citation
Folgar 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. Erratum In: J Biomed Opt. 2015 May;20(5):59802. — View Citation
Gabr H, Chen X, Zevallos-Carrasco OM, Viehland C, Dandrige A, Sarin N, Mahmoud TH, Vajzovic L, Izatt JA, Toth CA. VISUALIZATION FROM INTRAOPERATIVE SWEPT-SOURCE MICROSCOPE-INTEGRATED OPTICAL COHERENCE TOMOGRAPHY IN VITRECTOMY FOR COMPLICATIONS OF PROLIFERATIVE DIABETIC RETINOPATHY. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S110-S120. doi: 10.1097/IAE.0000000000002021. — View Citation
Grewal DS, Bhullar PK, Pasricha ND, Carrasco-Zevallos OM, Viehland C, Keller B, Shen L, Izatt JA, Kuo AN, Toth CA, Mruthyunjaya P. Intraoperative 4-Dimensional Microscope-Integrated Optical Coherence Tomography-Guided 27-Gauge Transvitreal Choroidal Biopsy for Choroidal Melanoma. Retina. 2017 Apr;37(4):796-799. doi: 10.1097/IAE.0000000000001326. — View Citation
Grewal DS, Carrasco-Zevallos OM, Gunther R, Izatt JA, Toth CA, Hahn P. Intra-operative microscope-integrated swept-source optical coherence tomography guided placement of Argus II retinal prosthesis. Acta Ophthalmol. 2017 Aug;95(5):e431-e432. doi: 10.1111/aos.13123. Epub 2016 Jun 20. No abstract available. — View Citation
Hahn 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. — View Citation
Hahn P, Migacz J, O'Connell R, Izatt JA, Toth CA. Unprocessed real-time imaging of vitreoretinal surgical maneuvers using a microscope-integrated spectral-domain optical coherence tomography system. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):213-20. doi: 10.1007/s00417-012-2052-2. Epub 2012 May 16. — View Citation
Hahn P, Migacz J, O'Connell R, Maldonado RS, Izatt JA, Toth CA. The use of optical coherence tomography in intraoperative ophthalmic imaging. Ophthalmic Surg Lasers Imaging. 2011 Jul;42 Suppl(0):S85-94. doi: 10.3928/15428877-20110627-08. — View Citation
Hahn 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. — View Citation
Hsu ST, Gabr H, Viehland C, Sleiman K, Ngo HT, Carrasco-Zevallos OM, Vajzovic L, McNabb RP, Stinnett SS, Izatt JA, Kuo AN, Toth CA. Volumetric Measurement of Subretinal Blebs Using Microscope-Integrated Optical Coherence Tomography. Transl Vis Sci Technol. 2018 Apr 5;7(2):19. doi: 10.1167/tvst.7.2.19. eCollection 2018 Apr. — View Citation
Kuo 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. — View Citation
Kuo 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. — View Citation
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Nam 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. — View Citation
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Pasricha ND, Bhullar PK, Shieh C, Carrasco-Zevallos OM, Keller B, Izatt JA, Toth CA, Freedman SF, Kuo AN. Four-dimensional Microscope-Integrated Optical Coherence Tomography to Visualize Suture Depth in Strabismus Surgery. J Pediatr Ophthalmol Strabismus. 2017 Feb 14;54:e1-e5. doi: 10.3928/01913913-20170201-01. — View Citation
Pasricha ND, Shieh C, Carrasco-Zevallos OM, Keller B, Cunefare D, Mehta JS, Farsiu S, Izatt JA, Toth CA, Kuo AN. Needle Depth and Big-Bubble Success in Deep Anterior Lamellar Keratoplasty: An Ex Vivo Microscope-Integrated OCT Study. Cornea. 2016 Nov;35(11):1471-1477. doi: 10.1097/ICO.0000000000000948. — View Citation
Pasricha ND, Shieh C, Carrasco-Zevallos OM, Keller B, Izatt JA, Toth CA, Kuo AN. Real-Time Microscope-Integrated OCT to Improve Visualization in DSAEK for Advanced Bullous Keratopathy. Cornea. 2015 Dec;34(12):1606-10. doi: 10.1097/ICO.0000000000000661. — View Citation
Qian R, Carrasco-Zevallos OM, Mangalesh S, Sarin N, Vajzovic L, Farsiu S, Izatt JA, Toth CA. Characterization of Long Working Distance Optical Coherence Tomography for Imaging of Pediatric Retinal Pathology. Transl Vis Sci Technol. 2017 Oct 16;6(5):12. doi: 10.1167/tvst.6.5.12. eCollection 2017 Oct. — View Citation
Seider MI, Tran-Viet D, Toth CA. MACULAR PSEUDO-HOLE IN SHAKEN BABY SYNDROME: UNDERSCORING THE UTILITY OF OPTICAL COHERENCE TOMOGRAPHY UNDER ANESTHESIA. Retin Cases Brief Rep. 2016 Summer;10(3):283-5. doi: 10.1097/ICB.0000000000000251. — View Citation
Shen L, Carrasco-Zevallos O, Keller B, Viehland C, Waterman G, Hahn PS, Kuo AN, Toth CA, Izatt JA. Novel microscope-integrated stereoscopic heads-up display for intrasurgical optical coherence tomography. Biomed Opt Express. 2016 Apr 6;7(5):1711-26. doi: 10.1364/BOE.7.001711. eCollection 2016 May 1. — View Citation
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Todorich B, Shieh C, DeSouza PJ, Carrasco-Zevallos OM, Cunefare DL, Stinnett SS, Izatt JA, Farsiu S, Mruthyunjaya P, Kuo AN, Toth CA. Impact of Microscope-Integrated OCT on Ophthalmology Resident Performance of Anterior Segment Surgical Maneuvers in Model Eyes. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT146-53. doi: 10.1167/iovs.15-18818. — View Citation
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* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8.5 years |
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