Reporting Clinical Endpoints in Studies of Minimally Invasive Glaucoma Surgery.

Minimally invasive glaucoma surgery (MIGS) refers to a group of procedures generally characterized by an ab interno approach, minimal trauma to ocular tissue, moderate efficacy, an excellent safety profile, and rapid recovery. The number of MIGS procedures continues to increase, and their use has become widespread among glaucoma and cataract specialists. Standardization of the methodology and reporting of clinical endpoints in MIGS investigations enhances interpretation and comparison across different studies. The assessment of surgical interventions should not only consider statistical significance, but also whether the outcome is meaningful to patients. Minimal clinically important difference (MCID) is defined as the smallest change in a treatment outcome that is considered beneficial for an individual patient and prompts a change in their clinical management, and expert consensus is an accepted approach to determine the MCID. The American Academy of Ophthalmology's Glaucoma Preferred Practice Pattern Panel is an expert panel that develops guidelines identifying characteristics and components of quality eye care. The panel recommends that the cumulative probability of surgical success at 2 years with Kaplan-Meier survival analysis be used as the primary efficacy endpoint in MIGS studies. The panel suggests that surgical success for standalone MIGS be defined as intraocular pressure (IOP) ≤ 21 mmHg and reduced ≥ 20% from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The proposed MCID for the cumulative probability of success of standalone MIGS at 2 years is 50%. The panel recommends that surgical success for MIGS combined with cataract extraction with intraocular lens implantation (CE-IOL) be defined as a decrease in glaucoma medical therapy ≥ 1 medication from baseline without an increase in IOP, or IOP ≤ 21 mmHg and reduced ≥ 20% from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The suggested MCID for the cumulative probability of success for CE-IOL/MIGS at 2 years is 65%.

Addressing Glaucoma in Myopic Eyes: Diagnostic and Surgical Challenges.

Epidemiological and genetic studies provide strong evidence supporting an association between myopia and glaucoma. The accurate detection of glaucoma in myopic eyes, especially those with high myopia, remains clinically challenging due to characteristic morphologic features of the myopic optic nerve in addition to limitations of current optic nerve imaging modalities. Distinguishing glaucoma from myopia is further complicated by overlapping perimetric findings. Therefore, longitudinal follow-up is essential to differentiate progressive structural and functional abnormalities indicative of glaucoma from defects that may result from myopia alone. Highly myopic eyes are at increased risk of complications from traditional incisional glaucoma surgery and may benefit from newer microinvasive glaucoma surgeries in select cases.

Deep Learning for Localized Detection of Optic Disc Hemorrhages.

PURPOSE: To develop an automated deep learning system for detecting the presence and location of disc hemorrhages in optic disc photographs. DESIGN: Development and testing of a deep learning algorithm. METHODS: Optic disc photos (597 images with at least 1 disc hemorrhage and 1075 images without any disc hemorrhage from 1562 eyes) from 5 institutions were classified by expert graders based on the presence or absence of disc hemorrhage. The images were split into training (n = 1340), validation (n = 167), and test (n = 165) datasets. Two state-of-the-art deep learning algorithms based on either object-level detection or image-level classification were trained on the dataset. These models were compared to one another and against 2 independent glaucoma specialists. We evaluated model performance by the area under the receiver operating characteristic curve (AUC). AUCs were compared with the Hanley-McNeil method. RESULTS: The object detection model achieved an AUC of 0.936 (95% CI = 0.857-0.964) across all held-out images (n = 165 photographs), which was significantly superior to the image classification model (AUC = 0.845, 95% CI = 0.740-0.912; P = .006). At an operating point selected for high specificity, the model achieved a specificity of 94.3% and a sensitivity of 70.0%, which was statistically indistinguishable from an expert clinician (P = .7). At an operating point selected for high sensitivity, the model achieves a sensitivity of 96.7% and a specificity of 73.3%. CONCLUSIONS: An autonomous object detection model is superior to an image classification model for detecting disc hemorrhages, and performed comparably to 2 clinicians.

Choroidal Effusions after Glaucoma Drainage Implant Surgery: Risk Factors and Surgical Management.

OBJECTIVE: To report the incidence of patients who developed choroidal effusions after glaucoma drainage implant (GDI) surgery and determine risk factors for and outcomes of surgical intervention. DESIGN: Retrospective case series. SUBJECTS: Medical records of 605 patients who underwent GDI surgery from January 1, 2017 to June 7, 2021 at New York University Langone Health and New York Eye and Ear Infirmary of Mount Sinai were reviewed. METHODS: Preoperative, intraoperative, and postoperative clinical data were obtained. Multivariate logistic regression evaluated the factors associated with the need for surgical intervention. Patient records were analyzed for effusion resolution, intraocular pressure (IOP), visual acuity (VA), and complications across treatment modalities. MAIN OUTCOME MEASURES: Incidence of choroidal effusion development and need for surgical intervention. RESULTS: Choroidal effusions developed in 110 (18%) patients (110 eyes). Surgical intervention to drain the effusion or ligate the implant tube was performed in 19 (17%) patients. The average time to surgical intervention was 47.6 days. Among patients who developed postoperative effusions, risk factors for requiring surgical intervention included history of selective laser trabeculoplasty (SLT) (P = 0.004; odds ratio [OR], 14.4), prior GDI surgery (P = 0.04; OR 8.7), 350-mm2 Baerveldt glaucoma implant placement (P = 0.05; OR, 4.8), and anterior chamber shallowing (AC; P < 0.001; OR, 25.1) in the presence of effusions. The subgroup that required multiple surgeries for effusion resolution had a significantly lower mean IOP at the most recent follow-up compared with those who received medical management only (P < 0.001). A higher percentage of patients who required surgical intervention lost VA at the most recent follow-up compared with patients whose effusions resolved with conservative management (i.e., medical management, AC viscoelastic injection). CONCLUSIONS: Choroidal effusions after GDI surgery resolved with conservative management in most patients. A history of SLT or GDI placement, implantation of a BGI-350, and the presence of a shallow chamber were risk factors for surgical intervention. Although interventions, such as surgical drainage are at times necessary, a better understanding of their impacts can help guide postoperative decisions. The risks and benefits of these procedures must be carefully considered in these high-risk eyes. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Results from the Primary Tube Versus Trabeculectomy Study and translation to clinical practice.

PURPOSE OF REVIEW: The Primary Tube Versus Trabeculectomy (PTVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery and trabeculectomy with mitomycin C (MMC) in eyes without previous incisional ocular surgery. This article reviews results from the PTVT Study and suggests how they may be translated to clinical practice. RECENT FINDINGS: Tube shunt surgery had a higher failure rate than trabeculectomy with MMC in the PTVT Study, and the difference was statistically significant at 1 year but not at 3 years and 5 years. Both surgical procedures reduced intraocular pressure (IOP) to the low teens throughout 5 years of follow-up. Mean IOPs were lower after trabeculectomy with MMC compared with tube shunt implantation, and the differences were statistically significant during the first postoperative year and at 3 years. The greater IOP reduction after trabeculectomy with MMC was achieved with significantly fewer glaucoma medications relative to tube shunt placement. Surgical complications were common in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was significantly higher after trabeculectomy with MMC than tube shunt surgery. The rates of late postoperative complications, cataract progression, and vision loss were similar with both surgical procedures. Serious complications producing vision loss and/or requiring a reoperation to manage the complication developed more frequently after trabeculectomy with MMC compared with tube shunt surgery, and the difference was statistically significant at 1 year but not at 3 years and 5 years postoperatively. SUMMARY: Tube shunt implantation and trabeculectomy with MMC are both viable surgical options for managing glaucoma in patients without previous incisional ocular surgery. Results from the PTVT Study support further expansion of tube shunt use beyond refractory glaucomas.

Leadership in Ophthalmology Professional Organizations: A Descriptive Analysis and Trends, 2002-2022.

PURPOSE: To describe characteristics and trends in appointed leaders of ophthalmology professional organizations between 2002 and 2022. DESIGN: Trend study. METHODS: This study used a Web-based search and data collection. Data were collected on 232 individuals appointed to leadership positions of ophthalmology professional organizations. Main outcome measures were demographic and publication data. RESULTS: Of the 232 ophthalmology leaders appointed between 2002 and 2022, 22.8% were female. Most leaders had subspecialty training (92.9%), practiced in the South (32.6%, P = .001), and practiced at academic institutions (64.8%). Leaders were appointed 32.7 ± 7.3 years after graduation from medical school. Significant variation existed in the number of publications (98.3 ± 104.0) and research productivity scores (29.2 ± 19.5) at the time of appointment. The number of female leaders doubled in 2012-2021 as compared to 2002-2011 (2002-2011: 14.5% female vs 2012-2021: 29.6% female; P = .01). Female leaders were generally appointed earlier in their careers as compared to male leaders (P = .005, male vs female in 2002-2011; P = .02 male vs female in 2012-2021). There were no statistically significant differences in the number of publications or research productivity scores among female vs male leaders. CONCLUSIONS: Leaders of ophthalmology professional organizations are largely fellowship-trained subspecialists practicing at academic institutions. Although the number of female leaders of ophthalmology professional organizations has grown over time, most leaders are male. Female leaders tend to be earlier in their careers than male leaders; however, there is no statistically significant difference in research productivity scores among female vs male leaders.

Head and Neck Region Dermatological Ultraviolet-Related Cancers are Associated with Exfoliation Syndrome in a Clinic-Based Population.

OBJECTIVE: We assessed the relationship between ultraviolet (UV)-associated dermatological carcinomas (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) and exfoliation syndrome (XFS) or exfoliation glaucoma (XFG). DESIGN: Case-control study. PARTICIPANTS: Between 2019 and 2021, 321 participants and control subjects (XFS or XFG = 98; primary open-angle glaucoma [POAG] = 117; controls = 106; ages 50-90 years) were recruited. METHODS: A cross-sectional survey assessing medical history, maximum known intraocular pressure, cup-to-disc ratio, Humphrey visual field 24-2, the propensity to tan or burn in early life, history of BCC or SCC, and XFS or XFG diagnosis. The multivariable models adjusted for age, sex, medical history, eye color, hair color, and likeliness of tanning versus burning at a young age. MAIN OUTCOME MEASURES: History of diagnosed XFS or XFG. RESULTS: Any history of BCC or SCC in the head and neck region was associated with a 2-fold higher risk of having XFS or XFG versus having POAG or being a control subject (odds ratio [OR], 2.01; 95% confidence interval [CI], 1.04-3.89) in a multivariable-adjusted analysis. We observed a dose-response association in which the chance of having XFS or XFG increased by 67% per head and neck BCC or SCC occurrence (OR, 1.67; 95% CI, 1.09-2.56). When we excluded POAG participants, head and neck BCC or SCC was associated with a 2.8-fold higher risk of XFS or XFG (OR, 2.80; 95% CI, 1.12-7.02), and each additional occurrence had a 2-fold higher risk of XFS or XFG (OR, 1.97; 95% CI, 1.09-3.58). The association between head and neck region BCC or SCC and POAG compared with the control subjects was null (OR, 1.42; 95% CI, 0.58-3.48). With BCC or SCC located anywhere on the body, there was a nonsignificantly higher risk of having XFS or XFG compared with having POAG or being a control subject (OR, 1.65; 95% CI, 0.88-3.09). CONCLUSIONS: Head and neck region BCCs or SCCs are associated with a higher risk of having XFS or XFG. These findings support prior evidence that head and neck UV exposure may be a risk factor for XFS.

How glaucoma care changed for the better after the pandemic.

PURPOSE OF REVIEW: The current article reviews enhancements to the delivery of glaucoma care that developed in response to the coronavirus disease 19 (COVID-19) pandemic and are likely to persist beyond its resolution. RECENT FINDINGS: Literature from the review period (2020-2021) includes reports highlighting contributions of the ophthalmology community to global health during the pandemic. Glaucoma practices worldwide have instituted more robust infection control measures to mitigate severe acute respiratory syndrome coronavirus 2 transmission in the outpatient setting, and many of these modifications will endure in the post-COVID era. Operational adjustments have led to the provision of more efficient glaucoma care. A hybrid care model involving technician-based diagnostic testing and subsequent virtual consultation with a glaucoma specialist has evolved as a useful adjunct to traditional face-to-face encounters with patients. SUMMARY: Glaucoma specialists, patients, and staff have adapted to a 'new normal' of glaucoma care delivery during the COVID-19 pandemic. Although innovation has propelled several improvements to glaucoma care during this global health crisis, significant barriers to more widespread implementation of teleglaucoma still exist. Whether, and in what capacity, the pandemic has permanently altered glaucoma practice patterns remains to be seen.

The American Glaucoma Society 100: Articles with Significant Impact on Clinical Glaucoma Care.

PURPOSE: To identify 100 articles with significant impact on the clinical care of patients with glaucoma. DESIGN: Cross-sectional study. PARTICIPANTS: A total of 108 members of the American Glaucoma Society (AGS) in the original survey and 63 in the follow-up survey. METHODS: The 100 most frequently cited English-language original articles relevant to glaucoma were identified via a Scopus search. The American Academy of Ophthalmology (AAO) Preferred Practice Pattern Glaucoma Panel selected an additional 100 articles including newer and "classic" papers. An anonymous survey including the list of 200 articles was distributed to the AGS membership. Survey participants were asked to rate the impact of each article on the clinical care of glaucoma patients using a 4-point Likert scale. Survey respondents were able to provide "write-in" suggestions for the AGS 100. A subsequent anonymous follow-up survey was distributed asking participants to use the same Likert scale to rate 31 "write-in" articles suggested in the original survey. The AGS 100 was created by ranking the top 100 articles based on mean Likert scores from the original and follow-up surveys. MAIN OUTCOME MEASURES: Original English-language articles that have influenced the clinical care of patients with glaucoma. RESULTS: The mean ± standard deviation Likert score of articles included in the AGS 100 was 2.9 ± 0.3 (range, 2.47-3.69). The median citation number was 345 (range, 11-2426). Publication year ranged from 1965 to 2020. Articles were published in 14 journals, the most common of which were Ophthalmology (42%), American Journal of Ophthalmology (21%), and Archives of Ophthalmology (20%). Forty-eight articles were derived from randomized clinical trials. CONCLUSIONS: The AGS 100 is a collection of articles judged to have significant clinical impact on glaucoma care. The list will serve as an online educational resource for ophthalmologists in training and in practice.

Glaucoma care during the coronavirus disease 2019 pandemic.

PURPOSE OF REVIEW: The current article reviews the impact of the coronavirus disease 2019 (COVID-19) pandemic on the delivery of ophthalmic, and specifically, glaucoma care. RECENT FINDINGS: Literature from the review period includes case series demonstrating the presence of severe acute respiratory syndrome coronavirus 2 RNA in the conjunctival secretions of patients with laboratory-confirmed COVID-19. The global ophthalmology community published reports outlining the enhanced infection control measures undertaken by different institutions around the world to mitigate transmission of the novel coronavirus. Telemedicine has been increasingly implemented in glaucoma practices to reduce in-office patient volume. New data regarding the efficacy and feasibility of tools for home monitoring of intraocular pressure, virtual visual field testing, and remote disc photography are reviewed. SUMMARY: COVID-19 has posed a global public health threat due to the severity of its contagion and associated morbidity and mortality. Glaucoma specialists have responded to the pandemic with innovative modifications to reduce viral transmission and optimize patient and staff safety in the office and operating room. The role of teleglaucoma has expanded and will continue to evolve as remote diagnostic devices undergo further refinement and validation.

Safety profile of minimally invasive glaucoma surgery.

PURPOSE OF REVIEW: This article reviews the safety profile of trabecular meshwork/Schlemm's canal-based, subconjunctival, and suprachoroidal minimally invasive glaucoma surgery (MIGS). RECENT FINDINGS: Prospective randomized clinical trials and metaanalyses published during the 2019-2020 review period provided important data regarding the safety profile of trabecular meshwork/Schlemm's canal-based MIGS. Transient hyphema and intraocular pressure spikes are among the most common complications associated with this category of MIGS, but more serious adverse events such as cyclodialysis cleft formation may also occur. Trabecular bypass microstents and the intracanalicular scaffold are further subject to device-related complications, including malposition and obstruction. Recent case reports and retrospective case series have further characterized the safety profile of the subconjunctival gel stent, with adverse events ranging from self-limited hypotony to visually devastating endophthalmitis and suprachoroidal hemorrhage. Five-year results of the COMPASS XT study demonstrated significantly greater endothelial cell loss in patients randomized to receive CyPass Micro-Stent (Alcon Laboratories, Fort Worth, TX, USA) in combination with cataract surgery versus those who underwent cataract surgery alone, and ultimately led to a Food and Drug Administration Class I recall of the device. SUMMARY: Trabecular meshwork/Schlemm's canal-based procedures are generally among the safest MIGS, with mostly self-limited and nonvision-threatening complications. Subconjunctival gel stent insertion is associated with both bleb-related and stent-specific adverse events, which are similar to those observed with trabeculectomy and tube shunt surgery, respectively. Removal of the CyPass Micro-Stent from the market underscores the need for high-quality, long-term safety data regarding MIGS.

The Effect of Phacoemulsification on Intraocular Pressure in Eyes with Preexisting Glaucoma Drainage Implants.

PURPOSE: To study the effect of phacoemulsification on intraocular pressure (IOP) control in patients with preexisting glaucoma drainage implants (GDIs). DESIGN: Retrospective, observational case series. PARTICIPANTS: A total of 45 patients (51 eyes) with previously placed GDIs who underwent phacoemulsification between January 2013 and March 2018. METHODS: The list of patients was obtained from billing records. Clinical data were retrieved from the corresponding electronic medical records. MAIN OUTCOME MEASURES: Intraocular pressure, number of glaucoma medications before and after phacoemulsification (postoperative day 1, week 1, months 1, 3, 6, 12, 18, and 24), rate of failure (failure defined as IOP >18 mmHg and IOP increase >20% at 2 consecutive visits after month 1, need for additional glaucoma surgery, or loss of light perception vision), and postoperative complications. RESULTS: Mean follow-up was 23.0 ± 11.1 months. The average interval between GDI surgery and phacoemulsification was 9.4 ± 6.7 months. An Ahmed glaucoma valve (AGV; New World Medical) was implanted in 12 eyes, a Baerveldt glaucoma implant (BGI; Johnson & Johnson Surgical Vision) was implanted in 36 eyes, and a Molteno (Molteno Ophthalmic Limited) glaucoma implant was implanted in 3 eyes. Before phacoemulsification, the mean IOP was 14.4 ± 4.4 mmHg on 2.1 ± 1.3 glaucoma medications. At postoperative month 24, the mean IOP was 12.6 ± 4.4 mmHg (n = 29, P = 0.519) on 2.0 ± 1.6 (P = 0.457) glaucoma medications. The reduction in IOP was significant only at postoperative week 1 (P = 0.031). The cumulative failure rate was 3.9% at 1 year and 11.8% at 2 years. The AGV group had a significantly higher mean IOP before phacoemulsification than the BGI group (P = 0.016). Analysis of covariance, taking the baseline IOP as a covariate, revealed no differences in postoperative IOP and number of glaucoma medications between groups, except for month 18 (1 patient in the BGI group had uncontrolled IOP requiring surgery). Postoperative complications included cystoid macular edema (10%), corneal decompensation (6%), and choroidal effusion (4%). CONCLUSIONS: Phacoemulsification after GDI surgery resulted in a transient reduction in IOP at postoperative week 1. Patients with previously placed AGVs had similar postoperative outcomes compared with those with BGIs.

Suture Stenting of a Tube Fenestration for Early Intraocular Pressure Control After Baerveldt Glaucoma Implant Surgery.

PURPOSE: To evaluate the efficacy and safety of a tube fenestration stented with a 10-0 polyglactin suture for controlling early postoperative intraocular pressure (IOP) after Baerveldt glaucoma implant (BGI) surgery. METHODS: The medical records of 110 patients (119 eyes) who underwent BGI surgery with a tube fenestration stented with a 10-0 polyglactin suture anterior to an occlusive tube ligature were retrospectively reviewed. Main outcome measures included IOP and number of glaucoma medications at postoperative day 1, week 1, and weeks 2 to 3 as well as complications occurring before ligature release. RESULTS: Mean±SD preoperative IOP was 30.9±9.3 mm Hg using an average of 3.8±1.1 glaucoma medications. A statistically significant reduction in IOP and glaucoma medications was observed at all timepoints during the first 3 postoperative weeks compared with baseline (P<0.001). Mean IOP on postoperative day 1, week 1, and weeks 2 to 3 was 18.4±12.2 mm Hg on no medication, 15.9±9.4 mm Hg on 1.0±1.3 medications, and 16.7±8.2 mm Hg on 1.2±1.5 medications, respectively. In total, 44 eyes (37%) achieved IOP control without glaucoma medication during period of tube occlusion. CONCLUSIONS: The use of a single, monofilament 10-0 polyglactin suture to stent a fenestration proximal to the occlusive ligature of a BGI tube is effective in controlling IOP in the early postoperative period. Hypotony-related complications were infrequent and resolved in all cases with in-office interventions.

Complications of micro-invasive glaucoma surgery.

PURPOSE OF REVIEW: Micro-invasive glaucoma surgery (MIGS) is gaining favor with both comprehensive ophthalmologists and glaucoma specialists due in part to its improved safety profile when compared to traditional incisional glaucoma surgery. Despite a micro-invasive approach and minimal induced tissue trauma, each MIGS procedure is associated with unique complications. The present article summarizes evidence from the 2016 to 2017 review period regarding the safety profiles of Schlemm's canal-based, suprachoroidal, and subconjunctival microstents. RECENT FINDINGS: Ab-interno microstents are subject to intraoperative malpositioning, which can result in luminal obstruction and decreased efficacy. Acutely elevated intraocular pressure (IOP) has been observed with the iStent (Glaukos Corp., Laguna Hills, CA, USA; 2-4.3%), Hydrus Microstent (Ivantis Inc., Irvine, CA, USA; 6%), Cypass Microstent (Alcon, Fort Worth, TX, USA; 3-10.8%), and Xen Gel Stent (Allergan Plc, Dublin, Ireland; 21.5%). Meanwhile, most cases of hypotony (IOP < 6 mmHg) occurred within the first postoperative month, resolved with conservative treatment and without further surgical intervention, and were not associated with vision-threatening sequelae. SUMMARY: Interest in MIGS continues to grow as these procedures allow surgeons to intervene earlier in the disease course for patients with milder stages of glaucoma. Complications associated with MIGS, albeit infrequent and mostly transient, do occur despite a less invasive approach than trabeculectomy and tube shunt surgery.

Suprachoroidal shunts.

PURPOSE OF REVIEW: This article reviews recent studies evaluating the efficacy and safety of ab externo and ab interno suprachoroidal shunts designed to augment uveoscleral outflow in patients with open angle glaucoma. RECENT FINDINGS: The Gold Shunt and STARflo are placed into the suprachoroidal space via an ab externo approach, while the CyPass Micro-Stent and iStent Supra are inserted ab interno through a clear corneal incision. A small randomized clinical trial suggested similar efficacy among two different models of the Gold Shunt and the Ahmed glaucoma valve. The pivotal multicenter, randomized COMPASS trial showed that the CyPass Micro-Stent combined with cataract surgery is more effective than cataract surgery alone through 2 years. Study results suggest a favorable safety profile for each suprachoroidal device and intraocular pressure-lowering to the mid-to-high teens with an associated reduction in medication burden. Given the relative novelty of these procedures, it is currently unknown whether fibroblastic proliferation within the suprachoroidal space may limit their long-term success. SUMMARY: Renewed interest in the suprachoroidal space has led to the development of new biocompatible glaucoma implants. Ab interno devices are easily combined with cataract surgery and preserve conjunctiva for future incisional glaucoma surgery. Additional data regarding the long-term efficacy and late complications of suprachoroidal shunts are needed.