Intraoperative OCT Guidance of Intraocular Surgery

NCT01588041 | Completed DMC

• 2 other identifiers: Pro00016827R01EY023039
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Eye Manifestations

Keywords

Microscope mounted SDOCT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (8)

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.

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \. Any ocular disease that restricts the ability to perform MIOCT scanning.

Sponsors & Collaborators

• Duke University: lead
• National Eye Institute (NEI): collaborator

Study Sites (2)

Duke University Eye Center

Durham, North Carolina, 27705, United States

Location

Cole Eye Institute at the Cleveland Clinic Lemer College of Medicine

Cleveland, Ohio, 44195, United States

Location

Related Publications (39)

• 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.

  PMID: 17574065 BACKGROUND

• Machemer 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.

  PMID: 8537019 BACKGROUND

• Tan DT, Mehta JS. Future directions in lamellar corneal transplantation. Cornea. 2007 Oct;26(9 Suppl 1):S21-8. doi: 10.1097/ICO.0b013e31812f685c.

  PMID: 17881911 BACKGROUND

• Singh 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.

  PMID: 21813553 BACKGROUND

• Weiland 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.

  PMID: 22047893 BACKGROUND

• Shin 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.

  PMID: 21955988 BACKGROUND

• Machemer 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.

  PMID: 623191 BACKGROUND

• Parel 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.

  PMID: 4812085 BACKGROUND

• 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.

  PMID: 26175961 BACKGROUND

• 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.

  PMID: 25829349 BACKGROUND

• 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.

  PMID: 25213121 BACKGROUND

• 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.

  PMID: 24441877 BACKGROUND

• 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.

  PMID: 23659972 BACKGROUND

• 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.

  PMID: 23538579 BACKGROUND

• 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.

  PMID: 23190928 BACKGROUND

• 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.

  PMID: 22585009 BACKGROUND

• Tao YK, Ehlers JP, Toth CA, Izatt JA. Intraoperative spectral domain optical coherence tomography for vitreoretinal surgery. Opt Lett. 2010 Oct 15;35(20):3315-7. doi: 10.1364/OL.35.003315.

  PMID: 20967051 BACKGROUND

• Ehlers JP, Gupta PK, Farsiu S, Maldonado R, Kim T, Toth CA, Mruthyunjaya P. Evaluation of contrast agents for enhanced visualization in optical coherence tomography. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6614-9. doi: 10.1167/iovs.10-6195. Epub 2010 Nov 4.

  PMID: 21051711 BACKGROUND

• 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.

  PMID: 21282565 BACKGROUND

• 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.

  PMID: 21790116 BACKGROUND

• 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.

  PMID: 22084218 BACKGROUND

• 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.

  PMID: 26509766 BACKGROUND

• Viehland C, Keller B, Carrasco-Zevallos OM, Nankivil D, Shen L, Mangalesh S, Viet du T, Kuo AN, Toth CA, Izatt JA. Enhanced volumetric visualization for real time 4D intraoperative ophthalmic swept-source OCT. Biomed Opt Express. 2016 Apr 12;7(5):1815-29. doi: 10.1364/BOE.7.001815. eCollection 2016 May 1.

  PMID: 27231623 BACKGROUND

• 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.

  PMID: 27231616 BACKGROUND

• 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.

  PMID: 26655385 BACKGROUND

• 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.

  PMID: 27409495 BACKGROUND

• 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.

  PMID: 27409466 BACKGROUND

• 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.

  PMID: 27321093 BACKGROUND

• 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.

  PMID: 27538478 BACKGROUND

• 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.

  PMID: 27673716 BACKGROUND

• 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.

  PMID: 27442318 BACKGROUND

• 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.

  PMID: 28196266 BACKGROUND

• 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.

  PMID: 28384676 BACKGROUND

• 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.

  PMID: 28663853 BACKGROUND

• 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.

  PMID: 28930381 BACKGROUND

• 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.

  PMID: 29057163 BACKGROUND

• 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.

  PMID: 29324591 BACKGROUND

• 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.

  PMID: 29651361 BACKGROUND

• 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.

  PMID: 30405965 BACKGROUND

MeSH Terms

Conditions

Eye Manifestations

Condition Hierarchy (Ancestors)

Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia A Toth, MD

  Duke University Health System, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

• Joseph A Izatt, PhD

  Duke University Department of Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: September 1, 2009
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)