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%.

Selective Laser Trabeculoplasty for the Treatment of Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the current published literature for high-quality studies on the use of selective laser trabeculoplasty (SLT) for the treatment of glaucoma. This is an update of the Ophthalmic Technology Assessment titled, "Laser Trabeculoplasty for Open-Angle Glaucoma," published in November 2011. METHODS: Literature searches in the PubMed database in March 2020, September 2021, August 2022, and March 2023 yielded 110 articles. The abstracts of these articles were examined to include those written since November 2011 and to exclude reviews and non-English articles. The panel reviewed 47 articles in full text, and 30 were found to fit the inclusion criteria. The panel methodologist assigned a level I rating to 19 studies and a level II rating to 11 studies. RESULTS: Data in the level I studies support the long-term effectiveness of SLT as primary treatment or as a supplemental therapy to glaucoma medications for patients with open-angle glaucoma. Several level I studies also found that SLT and argon laser trabeculoplasty (ALT) are equivalent in terms of safety and long-term efficacy. Level I evidence indicates that perioperative corticosteroid and nonsteroidal anti-inflammatory drug eye drops do not hinder the intraocular pressure (IOP)-lowering effect of SLT treatment. The impact of these eye drops on lowering IOP differed in various studies. No level I or II studies exist that determine the ideal power settings for SLT. CONCLUSIONS: Based on level I evidence, SLT is an effective long-term option for the treatment of open-angle glaucoma and is equivalent to ALT. It can be used as either a primary intervention, a replacement for medication, or an additional therapy with glaucoma medications. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Central Visual Field Testing in Early Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To evaluate the current published literature on the utility of the 10-2 visual field (VF) testing strategy for the evaluation and management of early glaucoma, defined here as mean deviation (MD) better than -6 decibels (dB). METHODS: A search of the peer-reviewed literature was last conducted in June 2023 in the PubMed database. Abstracts of 986 articles were examined to exclude reviews and non-English-language articles. After inclusion and exclusion criteria were applied, 26 articles were selected, and the panel methodologist rated them for strength of evidence. Thirteen articles were rated level I, and 8 articles were rated level II. The 5 level III articles were excluded. Data from the 21 included articles were abstracted and reviewed. RESULTS: The central 12 locations on the 24-2 VF test grid lie within the central 10 degrees covered by the 10-2 VF test. In early glaucoma, defects detected within the central 10 degrees generally agree between the 2 tests. Defects within the central 10 degrees of the 24-2 VF test can predict defects on the 10-2 VF test, although the 24-2 may miss defects detected on the 10-2 VF test. In addition, results from the 10-2 VF test show better association with findings from OCT scans of the macular ganglion cell complex. Modifications of the 24-2 test that include extra test locations within the central 10 degrees improve detection of central defects found on 10-2 VF testing. CONCLUSIONS: Evidence to date does not support routine testing using 10-2 VF for patients with early glaucoma. However, early 10-2 VF testing may provide sufficient additional information for some patients, particularly those with a repeatable defect within the central 12 locations of the standard 24-2 VF test or who have inner retinal layer thinning on OCT scans of the macula. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Aqueous Shunts with Extraocular Reservoir for Open-Angle Adult Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To evaluate the recently published literature on the efficacy and safety of the use of aqueous shunts with extraocular reservoir for the management of adult open-angle glaucomas (OAGs). METHODS: A search of peer-reviewed literature was last conducted in April 2023 of the PubMed database and included only articles published since the last aqueous shunt Ophthalmic Technology Assessment, which assessed articles published before 2008. The abstracts of these 419 articles were examined, and 58 studies were selected for full-text analysis. After inclusion and exclusion criteria were applied, 28 articles were selected and assigned ratings by the panel methodologist according to the level of evidence. Twenty-five articles were rated level I and 3 articles were rated level II. There were no level III articles. RESULTS: Implantation of aqueous shunts with extraocular reservoir can lower intraocular pressure (IOP) by between one-third and one-half of baseline IOP, depending on whether it is undertaken as the primary or secondary glaucoma surgery. Success rates for aqueous shunts were found to be better than for trabeculectomies in eyes with prior incisional surgery. Conversely, in eyes without prior incisional surgery, implantation of aqueous shunts was found to have an overall lower success rate as the primary glaucoma procedure compared with trabeculectomy. Although both valved and nonvalved aqueous shunts with extraocular reservoir were effective, the nonvalved device generally achieved slightly lower long-term IOPs with fewer glaucoma medications and less need for additional glaucoma surgery. Both devices slow the rates of visual field progression with efficacy comparable with that of trabeculectomy. Early aqueous humor suppression after aqueous shunt implantation is recommended for the management of the postoperative hypertensive phase and long-term IOP control. No strong evidence supports the routine use of mitomycin C with aqueous shunt implantation for OAG. CONCLUSIONS: Implantation of aqueous shunts with extraocular reservoir, including valved or nonvalved devices, has been shown to be an effective strategy to lower IOP. Strong level I evidence supports the use of aqueous shunts with extraocular reservoir by clinicians for the management of adult OAG. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Trabecular Procedures Combined with Cataract Surgery for Open-Angle Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To determine the intraocular pressure (IOP) reduction of various trabecular procedures (a form of minimally invasive glaucoma surgery [MIGS]) combined with cataract surgery compared with cataract surgery alone, to compare the safety of the various trabecular procedures, and to highlight patient characteristics that may favor one trabecular procedure over another. METHODS: A search of English-language peer-reviewed literature in the PubMed database was initially conducted in February 2021 and updated in April 2023. This yielded 279 articles. Twenty studies met initial inclusion and exclusion criteria and were assessed for quality by the panel methodologist. Of these, 10 were rated level I, 3 were rated level II, and 7 were rated level III. Only the 10 level I randomized controlled trials (RCTs) were included in this assessment, and all were subject to potential industry-sponsorship bias. RESULTS: The current analysis focuses on the amount of IOP reduction (in studies that involved medication washout) and on IOP reduction with concurrent medication reduction (in studies that did not involve medication washout). Based on studies that performed a medication washout, adding a trabecular procedure to cataract surgery provided an additional 1.6 to 2.3 mmHg IOP reduction in subjects with hypertensive, mild to moderate open-angle glaucoma (OAG) at 2 years over cataract surgery alone, which itself provided approximately 5.4 to 7.6 mmHg IOP reduction. In other words, adding a trabecular procedure provided an additional 3.8% to 8.9% IOP reduction over cataract surgery alone, which itself provided 21% to 28% IOP reduction. There was no clear benefit of one trabecular procedure over another. Patient-specific considerations that can guide procedure selection include uveitis predisposition, bleeding risk, metal allergy, and narrowing of Schlemm's canal. There are no level I data on the efficacy of trabecular procedures in subjects with pretreatment IOP of 21 mmHg or less. CONCLUSIONS: Trabecular procedures combined with cataract surgery provide an additional mild IOP reduction over cataract surgery alone in hypertensive OAG subjects. Additional research should standardize outcome definitions, avoid industry sponsorship bias, and study the efficacy of these procedures in normotensive OAG. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Corneal Hysteresis for the Diagnosis of Glaucoma and Assessment of Progression Risk: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the current published literature on the utility of corneal hysteresis (CH) to assist the clinician in the diagnosis of glaucoma or in the assessment of risk for disease progression in existing glaucoma patients. METHODS: Searches of the peer-reviewed literature in the PubMed database were performed through July 2022. The abstracts of 423 identified articles were examined to exclude reviews and non-English articles. After inclusion and exclusion criteria were applied, 19 articles were selected, and the panel methodologist rated them for level of evidence. Eight articles were rated level I, and 5 articles were rated level II. The 6 articles rated level III were excluded. RESULTS: Corneal hysteresis is lower in patients with primary open-angle glaucoma, primary angle-closure glaucoma, pseudoexfoliative glaucoma, and pseudoexfoliation syndrome compared with normal subjects. Interpretation of low CH in patients with high intraocular pressure (IOP) or on topical hypotensive medications is complicated by the influence of these parameters on CH measurements. However, CH is also lower in treatment-naïve, normal-tension glaucoma patients compared with normal subjects who have a similar IOP. In addition, lower CH is associated with an increased risk of progression of glaucoma based on visual fields or structural markers in open-angle glaucoma patients, including those with apparently well-controlled IOP. CONCLUSIONS: Corneal hysteresis is lower in glaucoma patients compared with normal subjects, and lower CH is associated with an increased risk of disease progression. However, a causal relationship remains to be demonstrated. Nevertheless, measurement of CH complements current structural and functional assessments in determining disease risk in glaucoma suspects and patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Efficacy of Combined Suprachoroidal Stent and Cataract Surgery in Patients With Glaucoma.

PURPOSE: The purpose of this study was to evaluate the efficacy of intraocular pressure (IOP) control after combined CyPass Micro-Stent implantation and cataract surgery (combined surgery). METHODS: All cases of combined surgery performed from February 2017 to July 2018 at Stein and Doheny Eye Institutes were reviewed. The primary outcome was a qualified success with stratified IOP targets based on criteria: final IOP (A) ≤18 mm Hg and reduction of 20%, (B) ≤15 mm Hg and reduction of 25%, (C) ≤12 mm Hg and reduction of 30%. Secondary outcome measures included postoperative IOP and number of medications, complications, additional glaucoma surgery, and postoperative refractive error. Predictive factors for failure were investigated. IOP spike was defined as a postoperative IOP ≥30 or >10 mm Hg increase from preoperative IOP. RESULTS: One hundred forty-one eyes (107 patients) were included. Mean (±SD) preoperative IOP was 15.4±3.4 mm Hg on an average of 2.2±1.1 medications. A statistically significant reduction in IOP and number of medications was seen at 12 months (13.8±4.2 mm Hg, 1.3±1.3 medications, P<0.001). Fifteen eyes (10.6%) had a postoperative IOP spike. Thirteen eyes (9.2%) experienced 17 complications (12.1%). Additional glaucoma surgery was performed in 3 eyes (2 patients). Cumulative success rates at 1 year based on criteria A, B, and C were 42%, 33%, and 28%, respectively. Lower preoperative IOP, greater preoperative medication number, the occurrence of postoperative IOP spike, and non-Caucasian ethnicity were associated with failure. CONCLUSION: Combined CyPass Micro-Stent implantation and cataract surgery may reduce glaucoma medication burden with a success rate of 28% to 42% at 1 year.

Clinical results of ab interno trabeculotomy using the trabectome in patients with uveitic glaucoma.

IMPORTANCE: To evaluate the safety and efficacy of ab interno trabeculotomy (AIT) (trabecular ablation) with the trabectome in patients with uveitic glaucoma. BACKGROUND: Traditional glaucoma filtration surgeries in the uveitic patient population come with a higher risk of complications such as failure and hypotony. DESIGN: Retrospective observational cohort study. PARTICIPANTS: All patients diagnosed with uveitic glaucoma were included in this study. Patients were excluded if they have less than 12 months of follow-up. METHODS: All patients who received AIT alone or combined with phacoemulsification. MAIN OUTCOME MEASURES: Major outcomes include intraocular pressure (IOP), number of glaucoma medications and secondary glaucoma surgery, if any. Kaplan-Meier method was used for survival analysis and success was defined as IOP ≤21 mmHg, at least 20% IOP reduction from baseline for any two consecutive visits after 3 months, no additional glaucoma medications, and no secondary glaucoma surgery. RESULTS: A total of 45 eyes, 45 patients, with an average age of 52 years were included in the study. The majority were Japanese (40%) and underwent AIT alone (71%). IOP was reduced from 29.2 ± 8.0 to 16.7 ± 4.6 mmHg at 12 months (P < .01*), while the number of glaucoma medications was reduced from 4.0 ± 1.0 to 2.5 ± 1.6 (P < .01*). Survival rate at 12 months was 91%. Six cases required secondary glaucoma surgery and no other serious complication were reported. CONCLUSIONS AND RELEVANCE: The trabectome AIT procedure appears to be effective in reducing IOP in uveitic glaucoma patients. Although no statistically significant difference was found in the number of glaucoma medications, a decreasing trend was found.

Novel and Semiautomated 360-Degree Gonioscopic Anterior Chamber Angle Imaging in Under 60 Seconds.

PURPOSE: Obtaining slit-lamp gonioscopic images requires a high level of expertise and can be time consuming. The images typically are limited to 4 quadrants with limited resolution and can be affected by different lighting conditions. Our goal was to study the ability of the novel imaging system to quickly and easily document the full 360 degrees of the anterior chamber angle in a standardized manner. DESIGN: Cross-sectional cohort study. SUBJECTS: Eighty-four eyes from 50 subjects were included in this study, including 26 eyes from 17 normal participants and 58 eyes from 33 patients diagnosed with glaucoma. METHODS: A newly introduced, commercially available gonioscope (GS-1, NIDEK Co, Gamagori, Japan) was utilized to perform semiautomated imaging of the full 360-degree iridocorneal angle on participants under an institutional review board-approved study. Topical proparacaine was administered to the eye to anesthetize the eye and imaging was completed using the 16-mirror, machine-attached gonioscopic lens coupled with lubricating ophthalmic gel ointment. The first step of the 2-step image acquisition process is analogous to manual gonioscopy, whereas the second step is performed by the instrument in an automated fashion. First, the instrument is manually moved forward by the operator to allow the machine-attached lens to make contact with the patient's corneal surface (time = 30 seconds). Second, the instrument automatically achieves fine focus on the iridocorneal angle and takes 16 sequential high-resolution photographs at multiple different focal planes (time = less than 30 seconds). MAIN OUTCOME MEASURES: Successful qualitative imaging of anterior chamber iridocorneal angle in normal and glaucomatous eyes including visualization of various implanted devices within angle before and after surgery in less than 1 minute per eye. RESULTS: In this pilot study, the full 360 degrees of iridocorneal angle of 84 eyes from 50 normal participants or glaucoma patients were successfully imaged using NIDEK GS-1 in under 60 seconds. All eyes were able to be imaged in 1 sitting, and we were able to image the full spectrum of angle from narrow/closed to fully open. The 360-degree views of the images were able to be displayed in 3 available formats (16-section display, a circular display, or a linear display). Successful imaging was also achieved of surgical devices and postsurgical conditions including CyPass, iStent, XEN, Baerveldt tube shunt, angle recession with iridodialysis, angle neovascularization, pigment dispersion, posttrabeculectomy sclerostomy and surgical iridectomy, and post-laser peripheral iridotomy. CONCLUSION: The newly introduced, semiautomated imaging system was able to document the full 360-degree iridocorneal angle views in normal and glaucoma eyes in less than 1 minute, which may allow longitudinal evaluation in a standardized manner. Furthermore, this system allows the ability to easily evaluate post-angle surgery changes and assess positions of implanted devices in the anterior chamber angle.

Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma: Short-Term Efficacy, Safety, and Impact of Surgical History on Outcomes.

PURPOSE: To assess the short-term efficacy and safety of micropulse transscleral diode laser cyclophotocoagulation (MP-TSCPC) in the management of refractory glaucoma and to compare outcomes based on prior glaucoma surgeries. DESIGN: Retrospective analysis. PARTICIPANTS: Patients with refractory glaucoma who underwent MP-TSCPC at a single institution by 1 of 4 surgeons. METHODS: Chart review of cases of MP-TSCPC using the Iridex Cyclo G6 (Mountain View, CA) laser with standard parameters and laser duration at the discretion of each treating physician. MAIN OUTCOME MEASURES: Probability of postoperative success was estimated by the Kaplan-Meier method. Success parameters included intraocular pressure (IOP) 6 to 21 mmHg with or without topical antihypertensive therapy, 20% or more IOP reduction from baseline for any 2 consecutive visits after 3 postoperative months, and no subsequent glaucoma surgery. RESULTS: One hundred sixteen eyes of 116 patients (mean age, 65.8±16.9 years) were included. Baseline IOP was 22.2±7.9 mmHg, and mean postoperative follow-up time was 6.3±3.4 months (range, 3-12 months.) Postoperative IOP at the final follow up was 15.3±6.6 mmHg (P < 0.01), corresponding to a reduction of approximately 6.9 mmHg (31.1%). Most eyes (66.4%) underwent at least 6 months of follow-up. Short-term probability of success was 93.1% at 3 months and 74.3% at 6 months. Eyes that had undergone prior traditional glaucoma surgery (trabeculectomy, tube shunt, excessive pressure-regulating shunt system miniature glaucoma shunt [Alcon, Fort Worth, TX], or a combination thereof) demonstrated a higher probability of success (67.6%) compared with eyes that had not (41.4%; P = 0.014). The most common complications were decline in best-corrected visual acuity (7.8%) and hypotony (1.7%). CONCLUSIONS: Micropulse transscleral diode laser cyclophotocoagulation has a significant short-term ocular hypotensive effect and favorable safety profile in eyes with refractory glaucoma. The probability of successful outcome was greater in eyes that had undergone prior traditional glaucoma surgery.

Short-Term Clinical Results of Ab Interno Trabeculotomy Using the Trabectome with or without Cataract Surgery for Open-Angle Glaucoma Patients of High Intraocular Pressure.

Purpose. To assess the safety and efficacy of Trabectome procedure in patients with preoperative intraocular pressure (IOP) of 30 mmHg or higher. Methods. All patients who had underwent Trabectome stand-alone or Trabectome combined with phacoemulsification were included. Survival analysis was performed by using Kaplan-Meier, and success was defined as IOP ≤ 21 mmHg, 20% or more IOP reduction from baseline for any two consecutive visits after 3 months, and no secondary glaucoma surgery. Results. A total of 49 cases were included with an average age of 66 (range: 13-91). 28 cases had Trabectome stand-alone and 21 cases had Trabectome combined with phacoemulsification. Mean IOP was reduced from a baseline of 35.6 ± 6.3 mmHg to 16.8 ± 3.8 mmHg at 12 months (p < 0.01∗), while the number of medications was reduced from 3.1 ± 1.3 to 1.8 ± 1.4 (p < 0.01∗). Survival rate at 12 months was 80%. 9 cases required secondary glaucoma surgery, and 1 case was reported with hypotony at day one, but resolved within one week. Conclusion. Trabectome seems to be safe and effective in patients with preoperative IOP of 30 mmHg or greater. Even in this cohort with high preoperative IOP, the end result is a mean IOP in the physiologic range.

Vision Loss and Recovery after Baerveldt Aqueous Tube Shunt Implantation.

This study aims to determine the course of vision loss after Baerveldt aqueous tube shunt placement and identify risk factors associated with unexplained severe long-term vision loss, or snuff-out. We retrospectively reviewed 247 eyes of 222 patients who underwent Baerveldt implantations at one of two academic institutions. Postoperative vision loss at 6 months following surgery was categorized as mild-to-moderate versus severe and long-term versus transient. Long-term vision loss, defined as 3 or more lines of Snellen visual acuity (VA) loss compared with preoperative VA, occurred in 63 of 247 eyes (25.5%), and 39 had mild-to-moderate and 24 had severe loss. Of these 63 eyes, 18 had no identifiable cause of vision loss. On multivariate analysis, poorer Snellen VA on postoperative day 1 (POD1) was found to be a significant risk factor for long-term vision loss (p = 0.005). In addition, the negative change in preoperative versus POD1 Snellen VA (p = 0.021) and the presence of split fixation involving the inferonasal quadrant on preoperative Humphrey visual field (p = 0.044) were significant risk factors for snuff-out. Transient vision loss occurred in 76 of 242 eyes (30.8%). In conclusion, vision loss is not uncommon after Baerveldt surgery, with snuff-out occurring in 2.4% of cases in this study.

Implantation of a second glaucoma drainage device.

PURPOSE: To evaluate success rates in controlling intraocular pressure (IOP) after implantation of a second glaucoma drainage device (GDD) with a Baerveldt glaucoma implant in patients with refractory glaucoma, with a secondary aim of reducing the need for postoperative glaucoma medications. MATERIAL AND METHODS: This retrospective, noncomparative, interventional study included patients undergoing a second GDD for uncontrolled glaucoma from a tertiary care glaucoma service. Data were obtained from the medical records for the preoperative period and after the 1st, 15th, and 30th day, 3, 6, and 12 months, and then yearly until the last postoperative visit. Visual acuity, IOP, and number of glaucoma medications (NGM) from the follow-up visits were compared to baseline. Success and failure criteria were analyzed based on IOP level or need of glaucoma medications. RESULTS: Forty-nine patients were studied, with a mean follow-up time of 25 ± 21 months. The mean preoperative IOP was 23.7 ± 8.2 mmHg, and decreased to 14.8 ± 4.0 mmHg after 1 year, 14.4 ± 3.9 mmHg after 2 years, and 16.6 ± 8.5 mmHg after 3 years. The mean preoperative NGM was 3.4 ± 1.3, and decreased to 2.0 ± 1.8 after 1 year, 2.5 ± 1.6 after 2 years, and 2.8 ± 2.0 after 3 years. Absolute success was 9% after 1 year for a postoperative IOP between 5 and 18 mmHg, and 76% for a postoperative IOP between 5 and 21 mmHg. The qualified success was 88% at the first and second years and 83% at the third year. CONCLUSION: With up to 3 years of follow-up, a second glaucoma drainage device was successful in reducing IOP to below 21 mmHg, but not as successful below 18 mmHg. The success rate is improved with the use of glaucoma medications with up to 3 years of follow-up.

Anterior Chamber Angle Morphometry Measurement Changes to Ambient Illumination Scaling in Visante Time Domain Optical Coherence Tomography.

PURPOSE: To test the effect of ambient illumination scaling on the reproducibility and reliability anterior chamber metrics using the Visante time domain optical coherence tomography (TD-OCT) instrument. MATERIALS AND METHODS: The inferior irido-corneal angles of 25 normal, healthy eyes were imaged twice with the Zeiss Visante TD-OCT under five strictly controlled ambient light conditions (foot candles (fc) measured with a light meter at camera/eye interface). Each eye was imaged 10 times totaling 250 assessments. Angle opening distance (AOD500/750), trabecular iris space area (TISA500/750), and scleral spur (SS) angle were graded twice by masked, trained graders at the Doheny Imaging Reading Center using the Visante's intrinsic tools. Lighting effects on measurements, intra-/inter-grader and acquisition analyses, and Bland-Altman plots were computed using Statistical Package for Social Science (SPSS Inc. version 18.0, Armonk, NY). RESULTS: With a near linear relationship of angle metrics to lights levels (R2 = 0.8-0.95), the analysis examines the differences from the brightest to darkest light levels. Decreasing ambient light levels from 1.0 to 0.0 fc decreased the average AOD500 measurement from 407 ± 136 µm to 315 ± 114 µm (mean percent difference (MPD) 29%, p < 0.001), AOD750 from 587 ± 184 µm to 496 ± 155 µm (MPD 18%, p < 0.001), TISA500 from 136 ± 43 µm2 to 101 ± 37 µm2 (MPD 35%, p < 0.001), TISA750 from 269 ± 81 µm2 to 212 ± 68 µm2 (MPD 27%, p < 0.001), and SS angle from 38.3% ± 9% to 32.1% ± 9% (MPD 19%, p < 0.001). Intra-/inter-grader results showed good reproducibility for each grader (MPD = 0.7-3%; coefficient of variation (CV) = 3.2-8.3%; R2 = 0.8-0.95; p < 0.001 for all metrics) and between graders (MPD = 1.4-5.9%; CV = 6.7-14.2%; R2 = 0.81-0.89; Pearson Correlation Coefficient (PCC) = 0.8-0.97 (p<0.001)). Bland-Altman plots did not demonstrate any apparent bias, with similar repeatability and agreement. CONCLUSIONS: The results of this study show the high sensitivity of the anterior chamber to changes in the illumination. The slight decrease in light had a corresponding large decrease in Anterior Chamber Angle (ACA) metrics. With clinical diagnoses and treatments of eye diseases relying on these angle measurements, these findings emphasize the importance of strictly controlling light conditions in order to obtain reproducible measurements of anterior chamber geometry.

Endoscopic cyclophotocoagulation versus second glaucoma drainage device after prior aqueous tube shunt surgery.

BACKGROUND: To evaluate the efficacy in controlling intraocular pressure (IOP) with endoscopic cyclophotocoagulation (ECP) versus implantation of a second glaucoma drainage device (GDD-2) in the treatment of uncontrolled glaucoma with a prior aqueous tube shunt. DESIGN: A nonrandomized retrospective chart review. PARTICIPANTS: Patients with refractory glaucoma following a failed initial tube shunt (Baerveldt Glaucoma Implant 350), who underwent ECP or GDD-2 with Baerveldt Glaucoma Implant as a second surgery. Twenty-five eyes underwent ECP, and 48 eyes received a GDD-2. METHODS: ECP or second tube-shunt surgery. MAIN OUTCOME MEASURES: Reduction in IOP and antiglaucoma medications, and Kaplan-Meier survival with success defined as lOP ≥ 5 mmHg and ≤ 21 mmHg and ≥ 20% reduction from preoperative IOP. Secondary outcome measures were visual acuity and the presence of any postoperative complications. RESULTS: Both ECP and GDD-2 significantly lowered IOP (Student's t test) and number of antiglaucoma medications (Wilcoxon paired signed rank test). There were no significant differences in postoperative IOP (Student's t test) or antiglaucoma medications (Mann Whitney test) between ECP and GDD-2 at 6 and 12 months. There was also no difference in the Kaplan-Meier survival outcomes between the two groups. CONCLUSION: Both ECP and GDD-2 are both effective as second surgeries for refractory glaucoma that has failed a prior aqueous shunt.

Assessment of Anterior Segment Measurements with Swept Source Optical Coherence Tomography before and after Ab Interno Trabeculotomy (Trabectome) Surgery.

Purpose. To compare the changes of anterior segment parameters, assessed by swept source anterior segment optical coherence tomography (AS-OCT) after combined Trabectome-cataract surgery and Trabectome-only surgery in open angle glaucoma patients. Methods. Thirty-eight eyes of 24 patients with open angle glaucoma were scanned with swept source AS-OCT before and 4 weeks after combined Trabectome-cataract or Trabectome-only surgery. Intraocular pressure, number of medications, and AS-OCT parameters, such as angle opening distance at 500 and 750 µm from the scleral spur (AOD500 and AOD750), trabecular-iris space area at 500 and 750 mm2 (TISA500, TISA750), angle recess area at 500 and 750 mm2 (ARA500, ARA750), trabecular iris angle (TIA), anterior chamber depth (ACD), anterior chamber width (ACW), and anterior chamber volume (ACV), were obtained before the surgery. These parameters were compared to evaluate whether the outcome of the surgery differed among the patients after the surgery. The width of the trabecular cleft was also measured for both groups. Results. The reduction of IOP and number of medications was found to be statistically significant in both groups (p < 0.001). ACD, ACV, and angle parameters such as AOD 500/750, TISA 500/750, ARA 500/750, and TIA500 showed significantly greater changes from the preoperative values to postoperative 1st month values in combined Trabectome-cataract surgery group (p < 0.05), whereas Trabectome-only group did not show statistically significant difference (p > 0.05). There was no statistically significant difference between two groups for the width of the trabecular cleft (p = 0.7). Conclusion. Anterior chamber angle parameters measured with swept source AS-OCT may be useful for evaluating glaucoma patients before and after Trabectome surgery with or without cataract surgery.

Clinical results of ab interno trabeculotomy using the Trabectome in patients with pigmentary glaucoma compared to primary open angle glaucoma.

BACKGROUND: To evaluate outcomes of Trabectome on pigmentary glaucoma (PG) patients compared to matched controls with primary open angle glaucoma (POAG). DESIGN: Prospective comparison study PARTICIPANTS: A total of 101 POAG cases were matched with 101 PG cases. METHODS: Data of the patients diagnosed with PG or POAG was obtained from Trabectome Study Group Database. A one-to-one exact matching was performed between POAG and pigmentary cases based on type of surgery, baseline IOP and baseline number of glaucoma medications. IOP and number of glaucoma medications were compared between groups by Wilcoxon test. Success was defined as IOP ≤ 21 mmHg, at least 20% IOP reduction from baseline for two consecutive visits after 3 months and no secondary surgery. MAIN OUTCOME MEASURES: Success rate after Trabectome surgery in PG patients. RESULTS: Baseline IOP for PG is 24.4 ± 7.7 mmHg and 24.2 ± 7.5 mmHg for POAG (P = 1.0), while baseline number of glaucoma medications was 2.8 ± 1.2 mmHg for PG and 2.8 ± 1.2 mmHg for POAG (P = 1.0). Postoperative IOP values at 12 months were 17.1 ± 5.0 for PG cases and 15.9 ± 4.2 mmHg for POAG cases. Postoperative number of glaucoma medications at 12 month was 2.1 ± 1.4 in PG cases and 2.4 ± 1.3 in POAG cases. There was no statistically significant difference between groups in IOP or number of medications at any time point. Survival rate at 12 months was 92% and 86% in PG and POAG, respectively (P = 0.47). Six PG cases and nine POAG cases required secondary surgery. CONCLUSION: Trabectome provides similar outcomes to PG patients and POAG patients.

Effects of light variation on Schwalbe's line-based anterior chamber angle metrics measured with cirrus spectral domain optical coherence tomography.

BACKGROUND: Evaluate the impact of variations in ambient lighting conditions on the reproducibility/reliability of Schwalbe's Line (SL)-based anterior chamber angle (ACA) metrics using spectral domain optical coherence tomography (SD-OCT). DESIGN: Images were taken at Doheny Eye Centers-UCLA clinic, which were randomized, masked and graded twice by dual reading centre graders. PARTICIPANTS: Twenty-five normal/healthy participants with open angles METHODS: Inferior angles were imaged using Cirrus SD-OCT under five light levels (foot-candles (fc) measured at camera-eye interface with Sper light-meter) with the instrument's corneal illumination function set to default level of 50 (CIdef) and low 5 (CIlow). Each eye was imaged 20 times, totaling 500 assessments. MAIN OUTCOME MEASURES: SL-angle-opening-distance (SL-AOD) and SL-trabecular-iris-space-area (SL-TISA) measured using custom ImageJ software. Intra-/inter-grader variability analyses were completed using Statistical-Package-for-Social-Science and Bland-Altman plots demonstrated limits of agreement for comparisons. RESULTS: Light level demonstrated a linear relationship with angle size, thus differences from highest to lowest light levels were compared. Decreasing light from 1.0 → 0.0fc at CIdef decreased SL-AOD from 394 µm +/- 137 µm → 356 µm +/- 137 µm (mean percent difference (MPD) = 10.71%,P < 0.001) and SL-TISA from 297 µm(2) +/- 114 µm(2) → 261 µm(2) +/- 109 µm(2) (MPD = 13.7%, P < 0.001). Decreasing from 1.0 → 0.0fc at CIlow decreased SL-AOD from 366 µm +/- 136 µm → 329 µm +/- 122 µm (MPD = 10.9%, P < 0.001) and SL-TISA from 271 µm(2) +/- 113 µm(2) → 234 µm(2) +/- 98 µm(2) (MPD = 15.8%, P < 0.001). There was 7.9/11.4% (both P < 0.001) difference for SL-AOD/SL-TISA between CIdef → CIlow at 1.0fc, and 7.7/9.4% (both P < 0.001) difference at 0.0fc. Intra-/inter-grader results showed high reproducibility for all metrics (MPD = 0.33-4.4%; CV = 0.96-1.36; PCC = 0.93-0.95(P < 0.001); R2 = 0.94-0.98). Bland-Altman plots did not demonstrate bias, with repeat-ability and agreement among measurements. CONCLUSIONS: Using Cirrus SD-OCT, we found that SL-based ACA morphometrics are exquisitely sensitive to changes in ambient illumination and also corneal illumination by the OCT instrument. Consistently imaging in the darkest room possible is recommended (≤0.2 fce).

Endoscopic Cycloplasty (ECPL) and Lens Extraction in the Treatment of Severe Plateau Iris Syndrome.

PURPOSE: To describe the anatomic and clinical results of the treatment of severe plateau iris syndrome with lens extraction and endoscopic cycloplasty (ECPL). A secondary aim was to describe 4 novel ultrasound biomicroscopy (UBM) measurements for plateau iris syndrome. DESIGN: Prospective case series with UBM evaluation. METHODS: Included were 12 eyes of 6 patients with plateau iris refractory to laser iridotomy and iridoplasty, miotic and other glaucoma medical treatment, with appositional angle closure in at least 3 quadrants. Treatment consisted of lens extraction and ECPL, an endoscopic diode laser treatment of the ciliary processes in the superior, nasal, and inferior quadrants. UBM measurements were taken in all quadrants before and after surgery. The untreated temporal quadrants were used as controls. Measurement parameters included: anterior chamber depth (ACD), angle opening distance (AOD 500), trabecular ciliary process distance (TCPD), iris ciliary process distance (ICPD), iris depth (ID), iridocorneal angle (ICA), and sulcus angle (SA). Four novel measurements included: ciliary process thickness (CPT), ciliary process width (CPW), ciliary process area (CPA), and iris ciliary process contact length (ICPCL). Visual acuity, intraocular pressure, glaucoma medications, and complications were also followed. RESULTS: The ACD, AOD 500, and ICA all increased significantly (P<0.001). ICPD, CPT, CPW, CPA, and ICPL all decreased significantly (P<0.01). Parameters remaining unchanged were: TCPD, ID, and SA. The untreated quadrants showed similar measurements to the preoperative measurements. There were no serious complications noted. DISCUSSION: Treating the ciliary processes with diode laser using an endoscopic approach (ECPL) and lens extraction, results in opening of the anterior chamber angle and shrinkage of the ciliary processes in the treated areas. This effect seems to be primarily a result of the laser treatment in combination rather than the lens extraction alone. This effectively reverses the anatomic cause and angle closure of plateau iris syndrome.

Endoscopic Cyclophotocoagulation and Pars Plana Ablation (ECP-plus) to Treat Refractory Glaucoma.

PURPOSE: To report clinical outcomes after pars plana endoscopic cyclophotocoagulation of the ciliary processes and pars plana (ECP-plus), a novel treatment for refractory glaucoma. DESIGN: Retrospective, noncomparative interventional case series. SETTING: multicenter tertiary referral academic and clinical practice. STUDY POPULATION: fifty-three eyes of 53 consecutive subjects undergoing ECP-plus who had uncontrolled intraocular pressure (IOP) despite prior glaucoma surgeries and maximally tolerated medical therapy. OBSERVATION PROCEDURE: retrospective analysis of clinical data after ECP-plus and pars plana vitrectomy. MAIN OUTCOME MEASURES: primary outcome was IOP at 6 and 12 months. Secondary outcomes were number of glaucoma medications and postoperative complications. RESULTS: Diagnoses were primary open-angle glaucoma (32%), chronic angle-closure glaucoma (26%), and secondary open-angle glaucoma (OAG, 42%); 50/53 of subjects had 6 months' and 28/53 had 12 months' follow-up data. Preoperative IOP was 27.9±7.5 mm Hg (mean±SD). Postoperative IOP at 6 mo was 10.2±5.6 and at 12 mo was 10.7±5.2 lower than preoperative levels (all P<0.0001). Cumulative treatment success was 81% at 6 mo and 78% at 12 mo. Number of medications fell from 3.4±1.2 pretreatment to 0.8±1.0 at 1 to 6 mo and 0.7±1.2 at 12 mo postoperatively (all P<0.0001). Complications in the initial postoperative period (<3 mo) were hypotony (3/53, 6%), fibrinous uveitis (2/53, 4%), and cystoid macular edema without hypotony (CME; 4/53, 6%). Complications beyond 6 mo occurred in 8/50 (16%) subjects as hypotony (4/50, 8%), choroidal detachment (4/50, 3 with IOP<5 and 1 with IOP≥5; 8%), CME without hypotony (3/50, 6%), and failed corneal graft (1/50, 2%). CONCLUSIONS: The mean IOP was lowered by at least 61% after ECP-plus and IOP lowering was sustained over the follow-up period. Fewer glaucoma medications were needed. Complication rates were comparable with or slightly higher than anterior endoscopic cyclophotocoagulation and acceptable given the refractory nature of disease being treated.