Safety and Efficacy of Epithelium-Off Corneal Collagen Cross-Linking for the Treatment of Corneal Ectasia: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the evidence on the safety and effectiveness of epithelium-off corneal collagen cross-linking (CXL) for the treatment of progressive corneal ectasia. METHODS: A literature search of the PubMed database was most recently conducted in March 2024 with no date restrictions and limited to studies published in English. The search identified 359 citations that were reviewed in abstract form, and 43 of these were reviewed in full text. High-quality randomized clinical trials comparing epithelium-off CXL with conservative treatment in patients who have keratoconus (KCN) and post-refractive surgery ectasia were included. The panel deemed 6 articles to be of sufficient relevance for inclusion, and these were assessed for quality by the panel methodologist; 5 were rated level I, and 1 was rated level II. There were no level III studies. RESULTS: This analysis includes 6 prospective, randomized controlled trials that evaluated the use of epithelium-off CXL to treat progressive KCN (5 studies) and post-laser refractive surgery ectasia (1 study), with a mean postoperative follow-up of 2.4 years (range, 1-5 years). All studies showed a decreased progression rate in treated patients compared with controls. Improvement in the maximum keratometry (Kmax) value, corrected distance visual acuity (CDVA), and uncorrected distance visual acuity (UDVA) was observed in the treatment groups compared with control groups. A decrease in corneal thickness was observed in both groups but was greater in the CXL group. Complications were rare. CONCLUSIONS: Epithelium-off CXL is effective in reducing the progression of KCN and post-laser refractive surgery ectasia in most treated patients with an acceptable safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Outcomes and Complications of Limbal Stem Cell Allograft Transplantation: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the safety and outcomes of keratolimbal allograft (KLAL) transplantation and living-related conjunctival limbal allograft (lr-CLAL) transplantation for bilateral severe/total limbal stem cell deficiency (LSCD). METHODS: Literature searches were last conducted in the PubMed database in February 2023 and were limited to the English language. They yielded 523 citations; 76 were reviewed in full text, and 21 met the inclusion criteria. Two studies were rated level II, and the remaining 19 studies were rated level III. There were no level I studies. RESULTS: After KLAL surgery, best-corrected visual acuity (BCVA) improved in 42% to 92% of eyes at final follow-up (range, 12-95 months). The BCVA was unchanged in 17% to 39% of eyes and decreased in 8% to 29% of eyes. Two of 14 studies that evaluated the results of KLAL reported a notable decline in visual acuity over time postoperatively. Survival of KLAL was variable, ranging from 21% to 90% at last follow-up (range, 12-95 months) and decreased over time. For patients undergoing lr-CLAL surgery, BCVA improved in 31% to 100% of eyes at final follow-up (range, 16-49 months). Of the 9 studies evaluating lr-CLAL, 4 reported BCVA unchanged in 30% to 39% of patients, and 3 reported a decline in BCVA in 8% to 10% of patients. The survival rate of lr-CLAL ranged from 50% to 100% at final follow-up (range, 16-49 months). The most common complications were postoperative elevation of intraocular pressure, persistent epithelial defects, and acute allograft immune rejections. CONCLUSIONS: Given limited options for patients with bilateral LSCD, both KLAL and lr-CLAL are viable choices that may provide improvement of vision and ocular surface findings. The studies trend toward a lower rejection rate and graft failure with lr-CLAL. However, the level and duration of immunosuppression vary widely between the studies and may impact allograft rejections and long-term graft survival. Complications related to immunosuppression are minimal. Repeat surgery may be needed to maintain a viable ocular surface. Reasonable long-term success can be achieved with both KLAL and lr-CLAL with appropriate systemic immunosuppression. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Advanced Corneal Imaging in Keratoconus: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the diagnostic capabilities of the newest generation of corneal imaging devices for the identification of keratoconus. METHODS: Corneal imaging devices studied included tomographic platforms (Scheimpflug photography, OCT) and functional biomechanical devices (imaging an air impulse on the cornea). A literature search in the PubMed database for English language studies was last conducted in February 2023. The search yielded 469 citations, which were reviewed in abstract form. Of these, 147 were relevant to the assessment objectives and underwent full-text review. Forty-five articles met the criteria for inclusion and were assigned a level of evidence rating by the panel methodologist. Twenty-six articles were rated level II, and 19 articles were rated level III. There were no level I evidence studies of corneal imaging for the diagnosis of keratoconus found in the literature. To provide a common cross-study outcome measure, diagnostic sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) were extracted. (A perfect diagnostic test that identifies all cases properly has an AUC of 1.0.) RESULTS: For the detection of keratoconus, sensitivities for all devices and parameters (e.g., anterior or posterior corneal curvature, corneal thickness) ranged from 65% to 100%. The majority of studies and parameters had sensitivities greater than 90%. The AUCs ranged from 0.82 to 1.00, with the majority greater than 0.90. Combined indices that integrated multiple parameters had an AUC in the mid-0.90 range. Keratoconus suspect detection performance was lower with AUCs ranging from 0.66 to 0.99, but most devices and parameters had sensitivities less than 90%. CONCLUSIONS: Modern corneal imaging devices provide improved characterization of the cornea and are accurate in detecting keratoconus with high AUCs ranging from 0.82 to 1.00. The detection of keratoconus suspects is less accurate with AUCs ranging from 0.66 to 0.99. Parameters based on single anatomic locations had a wide range of AUCs. Studies with combined indices using more data and parameters consistently reported high AUCs. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Visualization of surgical maneuvers using intraoperative real-time volumetric optical coherence tomography.

Ophthalmic microsurgery is traditionally performed using stereomicroscopes and requires visualization and manipulation of sub-millimeter tissue structures with limited contrast. Optical coherence tomography (OCT) is a non-invasive imaging modality that can provide high-resolution, depth-resolved cross sections, and has become a valuable tool in clinical practice in ophthalmology. While there has been substantial progress in both research and commercialization efforts to bring OCT imaging into live surgery, its use is still somewhat limited due to factors such as low imaging speed, limited scan configurations, and suboptimal data visualization. In this paper we describe, to the best of our knowledge, the translation of the fastest swept-source intraoperative OCT system with real-time volumetric imaging with stereoscopic data visualization provided via a heads-up display into the operating room. Results from a sampling of human anterior segment and retinal surgeries chosen from 93 human surgeries using the system are shown and the benefits that this mode of intrasurgical OCT imaging provides are discussed.

Systematic analysis of levels of evidence supporting American Academy of Ophthalmology Preferred Practice Pattern guidelines, 2012-2021.

BACKGROUND: Despite the increased emphasis on evidence-based medicine, the current state of evidence behind ophthalmology clinical practice guidelines is unknown. The purpose of this systematic analysis was to understand the levels of evidence (LOE) supporting American Academy of Ophthalmology (AAO) Preferred Practice Pattern (PPP) guidelines, assess changes over time, and compare LOE across ophthalmology subspecialties. METHODS: All current PPP guidelines and their immediate predecessors were comprehensively reviewed to identify all recommendations with LOE provided (I [randomized controlled trials], II [case-control or cohort studies], and III [nonanalytic studies]). RESULTS: Twenty-three out of 24 current PPPs had a prior edition. Among the PPPs with a prior edition, the number of recommendations with LOE decreased from 1254 in prior PPPs to 94 in current PPPs. The number of recommendations with LOE I decreased from 114 to 83, LOE II decreased from 147 to 2, and LOE III decreased from 993 to 9. However, the proportion of LOE I recommendations increased from 9 to 88%, driven by a disproportionate decrease in reporting of evidence lower than LOE I. Subgroup analysis by subspecialty showed similar trends (LOE I recommendations in prior PPPs vs current PPPs: retina: 57 [12%] vs 19 [100%]; cornea: 33 [5%] vs 24 [100%]; glaucoma: 9 [23%] vs 17 [100%]; cataract: 13 [17%] vs 18 [100%]). CONCLUSIONS: Trends in LOE reporting in PPP guidelines indicate an increasing emphasis on evidence from randomized controlled trials from 2012 to 2021. The decline in the number of recommendations with LOE reported suggests an area for improvement in future guidelines as the presence of LOE is crucial to facilitate interpretation of clinical practice guidelines.

Robotic Optical Coherence Tomography Retinal Imaging for Emergency Department Patients: A Pilot Study for Emergency Physicians' Diagnostic Performance.

STUDY OBJECTIVE: To evaluate the diagnostic performance of emergency physicians' interpretation of robotically acquired retinal optical coherence tomography images for detecting posterior eye abnormalities in patients seen in the emergency department (ED). METHODS: Adult patients presenting to Duke University Hospital emergency department from November 2020 through October 2021 with acute visual changes, headache, or focal neurologic deficit(s) who received an ophthalmology consultation were enrolled in this pilot study. Emergency physicians provided standard clinical care, including direct ophthalmoscopy, at their discretion. Retinal optical coherence tomography images of these patients were obtained with a robotic, semi-autonomous optical coherence tomography system. We compared the detection of abnormalities in optical coherence tomography images by emergency physicians with a reference standard, a combination of ophthalmology consultation diagnosis and retina specialist optical coherence tomography review. RESULTS: Nine emergency physicians reviewed the optical coherence tomography images of 72 eyes from 38 patients. Based on the reference standard, 33 (46%) eyes were normal, 16 (22%) had at least 1 urgent/emergency abnormality, and the remaining 23 (32%) had at least 1 nonurgent abnormality. Emergency physicians' optical coherence tomography interpretation had 69% (95% confidence interval [CI], 49% to 89%) sensitivity for any abnormality, 100% (95% CI, 79% to 100%) sensitivity for urgent/emergency abnormalities, 48% (95% CI, 28% to 68%) sensitivity for nonurgent abnormalities, and 64% (95% CI, 44% to 84%) overall specificity. In contrast, emergency physicians providing standard clinical care did not detect any abnormality with direct ophthalmoscopy. CONCLUSION: Robotic, semi-autonomous optical coherence tomography enabled ocular imaging of emergency department patients with a broad range of posterior eye abnormalities. In addition, emergency provider optical coherence tomography interpretation was more sensitive than direct ophthalmoscopy for any abnormalities, urgent/emergency abnormalities, and nonurgent abnormalities in this pilot study with a small sample of patients and emergency physicians.

Optical coherence tomography refraction and optical path length correction for image-guided corneal surgery.

Optical coherence tomography (OCT) may be useful for guidance of ocular microsurgeries such as deep anterior lamellar keratoplasty (DALK), a form of corneal transplantation that requires delicate insertion of a needle into the stroma to approximately 90% of the corneal thickness. However, visualization of the true shape of the cornea and the surgical tool during surgery is impaired in raw OCT volumes due to both light refraction at the corneal boundaries, as well as geometrical optical path length distortion due to the group velocity of broadband OCT light in tissue. Therefore, uncorrected B-scans or volumes may not provide an accurate visualization suitable for reliable surgical guidance. In this article, we introduce a method to correct for both refraction and optical path length distortion in 3D in order to reconstruct corrected OCT B-scans in both natural corneas and corneas deformed by needle insertion. We delineate the separate roles of phase and group index in OCT image distortion correction, and introduce a method to estimate the phase index from the group index which is readily measured in samples. Using the measured group index and estimated phase index of human corneas at 1060 nm, we demonstrate quantitatively accurate geometric reconstructions of the true cornea and inserted needle shape during simulated DALK surgeries.

Practice Patterns of Fundoscopic Examination for Diabetic Retinopathy Screening in Primary Care.

Importance: Primary care professionals (PCPs) have a central role in screening for diabetic retinopathy (DR), especially in settings where access to specialty eye care is limited. Data on current DR screening practice patterns in primary care are needed to inform screening strategies. Objectives: To assess the practice patterns of fundoscopic examination for DR screening in a large primary care network and to evaluate the sensitivity and accuracy of PCP fundoscopy for detecting DR. Design, Setting, and Participants: A retrospective cohort study was performed using random sampling and manual review of electronic health records of PCP fundoscopic examination documentation compared with documentation of an examination performed by an eye care professional (ophthalmologist or optometrist) within 2 years before or after primary care encounters. From a single-institution primary care network of 28 clinics, 7449 adult patients with diabetes seen at least once in the primary care network in 2019 were eligible for this study. Data from 2001 encounters were abstracted from the electronic health record for a random sample of 767 patients. Data analysis was performed from January 2021 to May 2022. Exposure: Fundoscopic examination by PCPs. Main Outcomes and Measures: The frequency of PCPs performing fundoscopy at least once in the calendar year for patients with diabetes. Univariate and multivariable logistic regression analyses were performed to identify patient, clinician, and clinic factors associated with PCPs performing fundoscopy at least once in the calendar year. The PCP examination results were compared with diagnoses made by eye care professionals to assess the sensitivity and accuracy of the findings from PCP examinations. Results: Among the 767 adult patients with diabetes included in the analysis, 387 (50.5%) were female, and the median age was 64 years (IQR, 54-71 years). Primary care professionals documented a fundoscopic examination for 93 patients (12.1%); all results were documented as normal. When eye care professional examination results were used as the reference standard, the accuracy of PCP fundoscopic examination was 62.7% (95% CI, 50.0%-73.9%) and sensitivity for detecting disease was 0.0% (95% CI, 0.0%-14.9%). No patient demographic or clinical characteristics were associated with PCPs performing fundoscopy. In multivariable logistic regression, the number of PCP years in practice was associated with greater odds of patients receiving fundoscopy at least once in the year (adjusted odds ratio per 10 years in practice, 1.26; 95% CI, 1.01-1.59; P = .04); having nurse practitioner credentials was associated with lower odds of receiving fundoscopy (adjusted odds ratio, 0.23; 95% CI, 0.04-0.79; P = .049; compared with having physician credentials); after adjusting for rural clinic location, clinic location in a primary care shortage area, and documentation of an up-to-date eye care professional examination by a PCP in the study year. Conclusions and Relevance: In this cohort study, fundoscopic examination was rarely performed and was not sensitive for detecting DR in primary care practice. Because the rate of DR screening by eye care professionals remains low, research to explore and break down barriers to the implementation of effective primary care-based DR screening strategies, such as teleretinal imaging, is needed to prevent vision loss from undiagnosed DR.

Intraocular Lens Implantation in the Absence of Zonular Support: An Outcomes and Safety Update: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the visual acuity results and complications of different surgical techniques for intraocular lens (IOL) implantation in the absence of zonular support. METHODS: Peer-reviewed literature searches were conducted last in PubMed and the Cochrane Library in July 2019. The searches yielded 734 citations of articles published in English. The panel reviewed the abstracts of these mostly retrospective case series studies, and 45 were determined to be relevant to the assessment objectives. Three articles were rated as level II evidence, and 42 articles were rated as level III evidence. RESULTS: Eight different types of IOL fixation techniques with at least 6-month follow-up were evaluated: anterior chamber IOL (ACIOL), iris-claw IOL, retropupillary iris-claw IOL, 10-0 polypropylene iris-sutured posterior chamber IOL (PCIOL), 10-0 polypropylene scleral-sutured PCIOL, 8-0 polypropylene scleral-sutured PCIOL, CV-8 polytetrafluoroethylene, and intrascleral haptic fixation (ISHF). Eight articles reported data comparing 2 techniques. The 45 studies had insufficient statistical power to compare the techniques conclusively. A qualitative analysis of similar types showed that trends in visual acuity outcomes were not inferior to those of ACIOL implantation, but the severity of preoperative pathologic features was not controlled for. Compared with ACIOL, complications of cystoid macular edema were higher in 10-0 polypropylene iris-sutured PCIOL and 8-0 polypropylene scleral-sutured PCIOL. Non-anterior chamber IOL techniques were less likely to report chronic uveitis. Chronic glaucoma was highest in the 8-0 polypropylene scleral-sutured PCIOL group. Although retinal detachment was infrequent overall, it was twice as common in both iris- and scleral-sutured PCIOLs (except CV-8 polytetrafluoroethylene suture) compared with nonsutured methods: ACIOL, iris-clipped IOL, and ISHF PCIOL. CONCLUSIONS: The evidence reviewed shows no superiority of any single IOL implantation technique in the absence of zonular support. The various techniques seem to have equivalent visual acuity outcomes and safety profiles. Each technique has its own profile of inherent risk of postoperative complications. Surgeons must educate patients on the importance of close, long-term follow-up as a result of the uncertain nature of these techniques. Large prospective studies are needed to confirm the long-term complication profiles of these various IOL implantation techniques.

Intraoperative aberrometry vs modern preoperative formulas in predicting intraocular lens power.

PURPOSE: To compare the outcomes of an intraoperative aberrometer (ORA) to the Barrett Universal II (Barrett II) and Hill-RBF 2.0 (Hill-RBF) intraocular lens (IOL) power calculation formulas. SETTING: Duke University Eye Center, Durham, North Carolina, USA. DESIGN: Retrospective study. METHODS: Patients without history of refractive corneal surgery who had an uneventful cataract surgery from April 2016 to June 2018 were enrolled. Refractive prediction error was calculated with the Barrett II formula, the Hill-RBF formula, and the ORA intraoperative aberrometer (OIA) and was stratified by axial length, IOL type, and the percentage of eyes within a diopteric range of target refraction. RESULTS: Nine-hundred forty-nine eyes were included. The mean and median absolute predictive errors were 0.29 diopters (D) and 0.23 D (Barrett II), 0.31 D and 0.24 D (Hill-RBF), and 0.31 D and 0.25 D (intraoperative aberrometry), respectively (P > .05). Axial length stratification did not influence statistical difference in the IOL prediction methods. Barrett II outperformed the OIA toric multifocal (P = .011) group. Postoperative refraction was within 0.50 D of target in 84% (Barrett II), 83% (Hill-RBF), and 82% (OIA) of eyes (P > .05). CONCLUSIONS: Comparing the OIA to the Barrett II and Hill-RBF calculators, there was minimal clinical difference in the toric multifocal group. Regarding postoperative predicted spherical equivalent, for patients without a history of refractive surgery and good potential visual acuity, refractive outcome was not improved by utilizing the OIA.

Optical Coherence Tomography Guided Robotic Needle Insertion for Deep Anterior Lamellar Keratoplasty.

OBJECTIVE: Deep anterior lamellar keratoplasty (DALK) significantly reduces the post-transplantation morbidity in patients eligible for partial-thickness cornea grafts. The popular "big bubble" technique for DALK is so challenging, however, that a significant fraction of corneal pneumodissection attempts fail for surgeons without extensive DALK-specific experience, even with previous-generation cross-sectional optical coherence tomography (OCT) guidance. We seek to develop robotic, volumetric OCT-guided technology capable of facilitating or automating the difficult needle insertion step in DALK. METHODS: Our system provides for real-time volumetric corneal imaging, segmentation, and tracking of the needle insertion to display feedback for surgeons and to generate needle insertion plans for robotic execution. We include a non-automatic mode for cooperative needle control for stabilization and tremor attenuation, and an automatic mode in which needle insertion plans are generated based on OCT tracking results and executed under surgeon hold-to-run control by the robot arm. We evaluated and compared freehand, volumetric OCT-guided, cooperative, and automatic needle insertion approaches in terms of perforation rate and final needle depth in an ex vivo human cornea model. RESULTS: Volumetric OCT visualization reduces cornea perforations and beneficially increases final needle depth in manual insertions by clinically significant amounts. Our automatic robotic needle insertion techniques meet or exceed surgeon performance in both needle placement and perforation rate. CONCLUSION: Volumetric OCT is a key enabler for surgeons, although robotic techniques can reliably replicate their performance. SIGNIFICANCE: Robotic needle control and volumetric OCT promise to improve outcomes in DALK.

Autologous Serum-Based Eye Drops for Treatment of Ocular Surface Disease: A Report by the American Academy of Ophthalmology.

PURPOSE: To describe the safety and effectiveness of using autologous serum-based eye drops for the treatment of severe dry eye and persistent corneal epithelial defect. METHODS: Literature searches of the PubMed and Cochrane Library databases were conducted most recently in March 2019. The searches identified 281 citations, which were reviewed in abstract form. Of these, 48 were selected for a full-text review, and 13 met the inclusion criteria and were assigned a quality-of-evidence rating by the panel methodologist. Eight of these studies were rated level II and 5 were rated level III; there were no level I studies. RESULTS: This analysis included 10 studies of the use of autologous serum-based eye drops for severe dry eye disease and 4 studies of persistent epithelial defect. Several studies showed good effectiveness, with some improvement in symptoms, signs, or both. Eight of the studies reported improved symptoms for severe dry eye disease, and all noted improvement in at least 1 clinical sign. For persistent epithelial defects, all of the studies showed improvement, with 3 of the 4 demonstrating an improvement rate of more than 90%. Adverse events were rare. CONCLUSIONS: Although autologous serum-based tears may be effective in the treatment of severe dry eye and persistent epithelial defect, conclusions are limited owing to the absence of controlled trials.

Optical Coherence Tomography-Guided Robotic Ophthalmic Microsurgery via Reinforcement Learning from Demonstration.

Ophthalmic microsurgery is technically difficult because the scale of required surgical tool manipulations challenge the limits of the surgeon's visual acuity, sensory perception, and physical dexterity. Intraoperative optical coherence tomography (OCT) imaging with micrometer-scale resolution is increasingly being used to monitor and provide enhanced real-time visualization of ophthalmic surgical maneuvers, but surgeons still face physical limitations when manipulating instruments inside the eye. Autonomously controlled robots are one avenue for overcoming these physical limitations. We demonstrate the feasibility of using learning from demonstration and reinforcement learning with an industrial robot to perform OCT-guided corneal needle insertions in an ex vivo model of deep anterior lamellar keratoplasty (DALK) surgery. Our reinforcement learning agent trained on ex vivo human corneas, then outperformed surgical fellows in reaching a target needle insertion depth in mock corneal surgery trials. This work shows the combination of learning from demonstration and reinforcement learning is a viable option for performing OCT guided robotic ophthalmic surgery.

Influence of corneal diameter on surgically induced astigmatism in small-incision cataract surgery.

OBJECTIVE: Clear corneal incisions (CCI) in cataract surgery create a variable amount of surgically induced astigmatism (SIA). As refractive outcomes become increasingly important, it is necessary to understand factors that impact SIA and refractive surprises. In this study, we evaluate the effect of horizontal corneal diameter (white-to-white, WTW) on SIA in 2.2 mm small-incision cataract surgery. DESIGN: Prospective study at an academic-university-based outpatient clinic (Duke Eye Center). PARTICIPANTS: We enrolled adults ≥18 years of age without prior corneal surgery or corneal pathology undergoing cataract surgery with a single surgeon (R.R.V.). METHODS: All surgeries were uncomplicated and performed through a manually constructed, limbal, temporal, or superotemporal 2.2 mm CCI. Enrolled participants received standard-of-care evaluations and postoperative management. SIA was calculated at the first postoperative month using the Jaffe and Clayman vector analysis equation. RESULTS: We enrolled 43 subjects (55 eyes) with a mean age of 71 years with WTW corneal diameter values ranging from 11.34 to 12.99 mm obtained from Lenstar® (Haag-Streit Group, Koeniz, Switzerland). Postoperative SIA ranged from 0.072 to 1.6 D (mean 0.47 D, standard deviation 0.33 D). SIA was plotted against WTW and best fit to a linear regression model with a slope of -0.056 and an R2 value of 0.006. CONCLUSIONS: In this prospective study, WTW diameter had minimal effects on the SIA in uncomplicated small-incisional cataract surgery through a 2.2 mm temporal or superotemporal CCI with a single surgeon. Our findings suggest that corneal diameter does not play a clinically significant role in this population undergoing small-incisional cataract surgery.

Advances in Whole-Eye Optical Coherence Tomography Imaging.

Contemporary anterior segment and retinal optical coherence tomography (OCT) systems only image their particular designated region of the eye and cannot image both areas of the eye at once. This separation is due to the differences in optical system design needed to properly image the front or back of the eye and also due to limitations in the imaging depth of current commercial OCT systems. More recently, research and commercial OCT systems capable of "whole-eye" imaging have been described. These whole-eye OCT systems enable applications such as ocular biometry for cataract surgery, ocular shape analysis for myopia, and others. Further, these whole-eye OCT systems allow us to image the eye as an integrated whole rather than as separate, independent divisions.

Constant linear velocity spiral scanning for near video rate 4D OCT ophthalmic and surgical imaging with isotropic transverse sampling.

Ultrahigh speed optical coherence tomography (OCT) systems with >100 kHz A-scan rates can generate volumes rapidly with minimal motion artifacts and are well suited for 4D imaging (volumes through time) applications such as intra-operative imaging. In such systems, high OCT data acquisition efficiency (defined as the fraction of usable A-scans generated during the total acquisition time) is desired to maximize the volumetric frame rate and sampling pitch. However, current methods for beam scanning using non-resonant and resonant mirror scanners can result in severe scan distortion and transverse oversampling as well as require acquisition dead times, which limit the acquisition efficiency and performance of ultrahigh speed 4D OCT. We introduce constant linear velocity spiral scanning (CLV-SC) as a novel beam scanning method to maximize the data acquisition efficiency of ultrahigh speed 4D OCT systems. We demonstrate that CLV-SC does not require acquisition dead times and achieves more uniform transverse sampling compared to raster scanning. To assess its clinical utility, we implement CLV-SC with a 400 kHz OCT system and image the anterior eye and retina of healthy adults at up to 10 volumes per second with isotropic transverse sampling, allowing B-scans with equal sampling pitch to be extracted from arbitrary locations within a single volume. The feasibility of CLV-SC for intra-operative imaging is also demonstrated using a 800 kHz OCT system to image simulated retinal surgery at 15 volumes per second with isotropic transverse sampling, resulting in high quality volume renders that enable clear visualization of surgical instruments and manipulation of tissue.

Real-time visualization and interaction with static and live optical coherence tomography volumes in immersive virtual reality.

Virtual reality (VR) head-mounted displays are an attractive technology for viewing intrasurgical optical coherence tomography (OCT) volumes because they liberate surgeons from microscope oculars. We demonstrate real-time, interactive viewing of OCT volumes in a commercial HTC Vive immersive VR system using previously reported ray casting techniques. Furthermore, we show interactive manipulation and sectioning of volumes using handheld controllers and guidance of mock surgical procedures in porcine eyes exclusively within VR. To the best of our knowledge, we report the first immersive VR-OCT viewer with stereo ray casting volumetric renders, arbitrary sectioning planes, and live acquisition support. We believe VR-OCT volume displays will advance ophthalmic surgery towards VR-integrated surgery.

Descemet Membrane Endothelial Keratoplasty: Safety and Outcomes: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the safety and outcomes of Descemet membrane endothelial keratoplasty (DMEK) for the surgical treatment of corneal endothelial dysfunction. METHODS: Literature searches were last conducted in the PubMed and the Cochrane Library databases most recently in May 2017. The searches, which were limited to English-language abstracts, yielded 1085 articles. The panel reviewed the abstracts, and 47 were determined to be relevant to this assessment. RESULTS: After DMEK surgery, the mean best-corrected visual acuity (BCVA) ranged from 20/21 to 20/31, with follow-up ranging from 5.7 to 68 months. At 6 months, 37.6% to 85% of eyes achieved BCVA of 20/25 or better and 17% to 67% achieved BCVA of 20/20 or better. Mean endothelial cell (EC) loss was 33% (range, 25%-47%) at 6 months. Overall change in spherical equivalent was +0.43 diopters (D; range, -1.17 to +1.2 D), with minimal induced astigmatism of +0.03 D (range, -0.03 to +1.11 D). The most common complication was partial graft detachment requiring air injection (mean, 28.8%; range, 0.2%-76%). Intraocular pressure elevation was the second most common complication (range, 0%-22%) after DMEK, followed by primary graft failure (mean, 1.7%; range, 0%-12.5%), secondary graft failure (mean, 2.2%; range, 0%-6.3%), and immune rejection (mean, 1.9%; range, 0%-5.9%). Overall graft survival rates after DMEK ranged from 92% to 100% at last follow-up. Best-corrected visual acuity after Descemet's stripping endothelial keratoplasty (DSEK) ranged from 20/34 to 20/66 at 9 months. The most common complications after DSEK were graft detachment (mean, 14%; range, 0%-82%), endothelial rejection (mean, 10%; range, 0%-45%), and primary graft failure (mean, 5%; range, 0%-29%). Mean EC loss after DSEK was 37% at 6 months. CONCLUSIONS: The evidence reviewed supports DMEK as a safe and effective treatment for endothelial failure. With respect to visual recovery time, visual outcomes, and rejection rates, DMEK seems to be superior to DSEK and to induce less refractive error with similar surgical risks and EC loss compared with DSEK. The rate of air injection and repeat keratoplasty were similar in DMEK and DSEK after the learning curve for DMEK.

Review of intraoperative optical coherence tomography: technology and applications [Invited].

During microsurgery, en face imaging of the surgical field through the operating microscope limits the surgeon's depth perception and visualization of instruments and sub-surface anatomy. Surgical procedures outside microsurgery, such as breast tumor resections, may also benefit from visualization of the sub-surface tissue structures. The widespread clinical adoption of optical coherence tomography (OCT) in ophthalmology and its growing prominence in other fields, such as cancer imaging, has motivated the development of intraoperative OCT for real-time tomographic visualization of surgical interventions. This article reviews key technological developments in intraoperative OCT and their applications in human surgery. We focus on handheld OCT probes, microscope-integrated OCT systems, and OCT-guided laser treatment platforms designed for intraoperative use. Moreover, we discuss intraoperative OCT adjuncts and processing techniques currently under development to optimize the surgical feedback derivable from OCT data. Lastly, we survey salient clinical studies of intraoperative OCT for human surgery.

Four-dimensional microscope- integrated optical coherence tomography to enhance visualization in glaucoma surgeries.

We report the first use of swept-source microscope-integrated optical coherence tomography (SS-MIOCT) capable of live four-dimensional (4D) (three-dimensional across time) imaging intraoperatively to directly visualize tube shunt placement and trabeculectomy surgeries in two patients with severe open-angle glaucoma and elevated intraocular pressure (IOP) that was not adequately managed by medical intervention or prior surgery. We performed tube shunt placement and trabeculectomy surgery and used SS-MIOCT to visualize and record surgical steps that benefitted from the enhanced visualization. In the case of tube shunt placement, SS-MIOCT successfully visualized the scleral tunneling, tube shunt positioning in the anterior chamber, and tube shunt suturing. For the trabeculectomy, SS-MIOCT successfully visualized the scleral flap creation, sclerotomy, and iridectomy. Postoperatively, both patients did well, with IOPs decreasing to the target goal. We found the benefit of SS-MIOCT was greatest in surgical steps requiring depth-based assessments. This technology has the potential to improve clinical outcomes.