Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

Peripapillary retinal nerve fiber layer thickness as a diagnostic tool for pseudophakic cystoid macular edema.

PURPOSE: To investigate the effects of pseudophakic cystoid macular edema (PCME) on retinal nerve fiber layer (RNFL) thickness before and after treatment using optical coherence tomography (OCT). METHODS: A retrospective, observational study of consecutive patients diagnosed with PCME after cataract surgery. Patients underwent macular and RNFL OCT imaging at time of diagnosis and during follow up. OCT was performed for both the study eye and the contralateral healthy eye which served as control. All patients were followed for a period of at least 6 months. RESULTS: Overall, 40 eyes of 40 patients with a mean age of 71.1 ± 8.1 years of which 45% (n = 18) were of male gender were included in this study. At presentation, the central thickness in the PCME eye was significantly higher than in the contralateral eye (515.7 ± 127.9µm versus 238.1 ± 41.8µm, p < 0.001). Similarly, all macular measurements were significantly higher in the PCME eye compared to the contralateral eye (p < 0.001 for all). In terms of RNFL measurements, the PCME eyes had greater global (p < 0.001), superonasal (p = 0.001) and superotemporal (p = 0.005) thickness values. PCME eyes demonstrated a significant decrease in thickness for all macular and RNFL parameters following resolution of CME (p < 0.05 for all). CONCLUSIONS: PCME patients presents with greater global, superotemporal and superonasal RNFL thickness in comparison to the other healthy eye. After resolution of PCME, there is significant thinning of RNFL. Peripapillary RNFL thickness may serve as an additional parameter for diagnosis and follow-up of PCME.

Long-Term Evaluation of Pseudoexfoliation Syndrome Post-Cataract Extraction.

The study aimed to examine the effect of cataract extraction on ophthalmologists' ability to detect pseudoexfoliation (PXF) syndrome. A total of 31 patients admitted for elective cataract surgery were enrolled in this prospective comparative study. Prior to surgery, patients underwent slit-lamp examination and gonioscopy conducted by experienced glaucoma specialists. Subsequently, patients were re-examined by a different glaucoma specialist and comprehensive ophthalmologists. Pre-operatively, 12 patients were diagnosed with PXF on the basis of a Sampaolesi line (100%), anterior capsular deposits (83%), and pupillary ruff deposits (50%). The remaining 19 patients acted as controls. All patients were re-examined 10-46 months post-operatively. Of the 12 patients with PXF, 10 (83%) were correctly diagnosed post-operatively by glaucoma specialists and 8 (66%) by comprehensive ophthalmologists. There was no statistically significant difference in PXF diagnosis. However, detection of anterior capsular deposits (p = 0.02), Sampaolesi lines (p = 0.04), and pupillary ruff deposits (p = 0.01) were significantly lower post-operatively. Diagnosis of PXF is challenging in pseudophakic patients as the anterior capsule is removed during cataract extraction. Therefore, PXF diagnosis in pseudophakic patients relies mainly on the presence of deposits at other anatomical sites, and careful attention to these signs is required. Glaucoma specialists may be more likely than comprehensive ophthalmologists to detect PXF in pseudophakic patients.

Azithromycin and Sildenafil May Have Protective Effects on Retinal Ganglion Cells via Different Pathways: Study in a Rodent Microbead Model.

Decreased blood flow to the optic nerve (ON) and neuroinflammation are suggested to play an important role in the pathophysiology of glaucoma. This study investigated the potential neuroprotective effect of azithromycin, an anti-inflammatory macrolide, and sildenafil, a selective phosphodiesterase-5 inhibitor, on retinal ganglion cell survival in a glaucoma model, which was induced by microbead injection into the right anterior chamber of 50 wild-type (WT) and 30 transgenic toll-like receptor 4 knockout (TLR4KO) mice. Treatment groups included intraperitoneal azithromycin 0.1 mL (1 mg/0.1 mL), intravitreal sildenafil 3 µL, or intraperitoneal sildenafil 0.1 mL (0.24 µg/3 µL). Left eyes served as controls. Microbead injection increased intraocular pressure (IOP), which peaked on day 7 in all groups and on day 14 in azithromycin-treated mice. Furthermore, the retinas and ON of microbead-injected eyes showed a trend of increased expression of inflammatory- and apoptosis-related genes, mainly in WT and to a lesser extent in TLR4KO mice. Azithromycin reduced the BAX/BCL2 ratio, TGFß, and TNFα levels in the ON and CD45 expression in WT retina. Sildenafil activated TNFα-mediated pathways. Both azithromycin and sildenafil exerted a neuroprotective effect in WT and TLR4KO mice with microbead-induced glaucoma, albeit via different pathways, without affecting IOP. The relatively low apoptotic effect observed in microbead-injected TLR4KO mice suggests a role of inflammation in glaucomatous damage.

Optical Coherence Tomography Angiography for the Differentiation of Glaucoma from Pituitary Macroadenoma Related Optic Disc Measurements.

OBJECTIVE: To determine the potential of optical coherence tomography (OCT) and OCT angiography (OCTA) to distinguish between glaucoma and pituitary macroadenoma by optic disc appearance. METHODS: This prospective case-control study comprised 31 patients: 23 with glaucoma (18 male, 5 female) and 8 with pituitary macroadenoma and chiasmatic compression (3 male, 5 female). The corresponding mean ages were 72.8 years (range 58-90) and 60.7 years (range 43-73). All participants underwent complete ophthalmological examination, spectral domain OCT and OCTA, and visual field testing. Clinical, imaging, and visual field results were compared between the groups. RESULTS: On OCT analysis, the glaucoma group had relatively lower peripapillary retinal nerve fiber layer (RNFL) thickness (65.79 ± 15.46, 86.0 ± 11.37, respectively, P = .002) and lower rim area (1.00 ± 0.22 mm2 and 1.2 ± 0.15 mm2, respectively, P = .005). On OCTA, peripapillary vessel density was significantly lower in all quadrants in the glaucoma group. The significance of these between-group differences was maintained when patients were stratified by visual field mean deviation. CONCLUSIONS: This is the first comparative analysis of optic disc morphology between glaucoma and pituitary macroadenoma using combined OCT and OCTA. The results yielded lower peripapillary RNFL thickness, lower rim area, and lower peripapillary vessel density in the glaucoma group. These parameters may aid in the initial differentiation between these two optic neuropathies.

Long-term outcomes of anti-vascular endothelial growth factor treatment in peripapillary choroidal neovascularisation due to age-related macular degeneration.

OBJECTIVE: To report the long-term outcomes of anti-vascular endothelial growth factor (VEGF) treatment in eyes with peripapillary choroidal neovascularisation (PPCNV) associated with age-related macular degeneration (AMD). METHODS: A retrospective cohort study included patients with AMD-related PPCNV. Eyes were treated with anti-VEGF according to pro re nata regimen. Inactivation index was calculated as the proportion of disease inactivity from the total follow up time. RESULTS: Sixty-seven eyes of 66 consecutive patients were included in the study; mean follow-up time was 53.2 months. Best corrected visual acuity (BCVA) remained stable for the first four years of follow up, with a significant deterioration in BCVA thereafter. Baseline BCVA was a significant predictor of final BCVA (p < 0.001). The mean inactivation index was 0.38 ± 0.23. Subretinal fluid (SRF) at presentation was significantly associated with decreased inactivation index (p < 0.05). Worse baseline BCVA, SRF and pigment epithelium detachment (PED), male sex, and younger patient age were associated with increased risk for recurrence after first inactivation (p < 0.05). CONCLUSION: The use of anti-VEGF agents in the treatment of AMD-related PPCNV managed to preserve BCVA in the first four years of follow-up. Male sex, SRF and PED at presentation and baseline BCVA are associated with increased risk for PPCNV recurrence after the first inactivation, and should prompt careful follow-up in these patients.

Thickness measurements taken with the spectralis OCT increase with decreasing signal strength.

BACKGROUND: Optical coherence tomography (OCT) is used worldwide by clinicians to evaluate macular and retinal nerve fiber layer (RNFL) characteristics. It is frequently utilized to assess disease severity, progression and efficacy of treatment, and therefore must be reliable and reproducible. OBJECTIVE: To examine the influence of signal strength on macular thickness parameters, macular volume measurement and RNFL thickness measured by spectral-domain optical coherence tomography (SD-OCT). METHODS: Macular thickness parameters, macular volume measurement and RNFL thickness were measured by the Spectralis® OCT (Heidelberg Engineering, Heidelberg, Germany). In each eye, the focusing knob was adjusted to obtain 4 images with different signal strengths - Low (below 15), Moderate (15-20), Good (20-25) and Excellent (above 25). The relationship between signal strength and measured data was assessed using the mixed model procedure. RESULTS: A total of 71 eyes of 41 healthy subjects were included. Central macular thickness, macular volume and mean RNFL thickness increased with decreasing signal strength. Specifically, eyes with excellent signal strength showed significantly thinner central macular thickness (p = 0.023), macular volume (p = 0.047), and mean RNFL thickness (p = 0.0139). CONCLUSIONS: Higher signal strength is associated with lower macular thickness, macular volume and RNFL thickness measurements. The mean differences between excellent and low-quality measurements were small implicating that SD-OCT is a reliable imaging tool even at low quality scans. It is imperative that the physician compares the signal strength of all scans, as minute differences may alter results.

Elevated intraocular pressure in children with acute lymphoblastic leukaemia: A prospective study.

Most childhood acute lymphoblastic leukaemia (ALL) protocols include high-dose steroid therapy. However, the known potential of high-dose steroids to significantly elevate intraocular pressure (IOP) and lead to glaucomatous optic neuropathy has not been intensively investigated in children with ALL. Moreover, as children with ALL do not routinely undergo IOP measurements, the need for IOP monitoring and therapy is unknown. We prospectively measured IOP in 90 children with newly diagnosed ALL attending a tertiary paediatric haematology/oncology centre, at diagnosis and at the middle and end of induction therapy. Ocular hypertension (IOP > 21 mm Hg) at any time point was documented in 64 children (71%), and the prevalence increased during induction. Thirty-six children (40%) had elevated IOP at ALL diagnosis before therapy initiation, and stratification to non-standard ALL was a risk factor. IOP reduction therapy was administered to 13 children (14%); none required surgery. Values normalised in all cases. On multivariate logistic regression analysis, dexamethasone therapy was a significant risk factor for ocular hypertension. High body mass index was an additional risk factor in children with elevated IOP at ALL diagnosis. Routine evaluation of IOP during steroid therapy is very important in children with ALL to ensure early intervention which may prevent permanent ocular damage.

Optical Coherence Tomography Biomarkers Predicting Visual Acuity Change after Intravitreal Bevacizumab Injections for Macular Edema Secondary to Branch Retinal Vein Occlusion.

PURPOSE: This study aimed to identify baseline optical coherence tomography (OCT) factors in branch retinal vein occlusion (BRVO) that predict response to bevacizumab injections. METHODS: It is a retrospective case series of consecutive patients that underwent OCT at diagnosis, and the central macular thickness (CMT), extent of disorganized retinal inner layers, and outer retinal layers including external limiting membrane, ellipsoid zone (EZ), and cone outer segment tips (COST) were measured. Patients received 3 consecutive monthly injections of bevacizumab followed by pro re nata treatment. The main outcome measure was improvement in best-corrected visual acuity (BCVA) after 1 year. Results are expressed as mean ± SD, and p value <0.05 was considered statistically significant. RESULTS: Overall, 66 eyes of 66 patients, with an average age of 68.5 ± 11.4 years, were included. The mean BCVA improved significantly from 0.68 logMAR at baseline to 0.50 logMAR at 1 year (p < 0.001). Baseline logMAR BCVA (r = 0.41, p < 0.001) and CMT (r = 0.23, p = 0.04) were associated with improvement while EZ (r = -0.24, p = 0.05) and COST (r = -0.32, p = 0.01) disruption with deterioration in BCVA. CONCLUSION: In patients with naïve BRVO treated with bevacizumab, BCVA improvement at 1 year can be predicted from baseline BCVA, CMT, extent of COST disruption, and EZ disruption.

Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure.

PRCIS: Intermediate-term results suggest that ab interno Minimally Invasive Micro Sclerostomy (MIMS) stent-less subconjunctival filtration procedure is a promising treatment option for patients with open-angle glaucoma (OAG). PURPOSE: MIMS is a novel ab interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance, and efficacy of MIMS in OAG patients. METHODS: Prospective, open-label, single arm clinical trial with intrasubject comparisons. Study participants were adults with OAG who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A.) in Chennai, India. Following mitomycin-C pretreatment, ab interno MIMS procedure was performed alone or combined with phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an intraocular pressure (IOP) ≥5 mm Hg and ≤18 mm Hg, and an IOP reduction of >20% as compared with baseline, with or without hypotensive medications, with no need for recurrent surgery. RESULTS: Twenty-one phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:s). Scleral tunnels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1 to 24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4 mm Hg, P<0.0001, n=23). The mean difference was -14.8 mm Hg (95% confidence interval: -17.6, -11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%), and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%), and 8 (57%) after 12, 24, and 52 weeks, respectively. CONCLUSIONS: The interim results suggest that MIMS procedure may be a simple and effective surgical option for early OAG patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.

Optical Coherence Tomography Prognostic Factors in Age-Related Macular Degeneration Patients with Peripapillary Choroidal Neovascularization.

PURPOSE: The aim of the study was to investigate the correlation between optical coherence tomography (OCT) findings and visual acuity outcomes after treatment with intravitreal bevacizumab (IVB) injections for age-related macular degeneration (AMD) patients with peripapillary choroidal neovascularization (PPCNV). METHODS: The study involved a retrospective case series of consecutive patients diagnosed with PPCNV secondary to AMD. All patients were treated with IVB injections with a follow-up time of 1 year. Data collected included best-corrected visual acuity (BCVA) and automated and manually measured OCT parameters. RESULTS: A total of 68 eyes were diagnosed with PPMV. Of them, 30 eyes of 30 patients aged 84.3 ± 6.9 years of which 63.3% female gender were included. Baseline BCVA was 0.46 ± 0.62 logMAR (Snellen 20/57), average choroidal thickness was 193.2 ± 22 µm, and mean number of IVB injections was 7.2 ± 1.9. After 1 year, BCVA was 0.56 ± 0.78 logMAR (Snellen 20/72) (p = 0.28). Eyes with greater central retinal thickness (r = -0.36, p = 0.05), greater subretinal hyper-reflective material (SHRM) area (r = -0.37, p = 0.05), and greater sub-retinal fluid (SRF) area (r = -0.73, p < 0.001) had a significantly smaller improvement in BCVA. Eyes with pigment epithelium detachment (PED) (0.68 ± 0.90 vs. 0.21 ± 0.12, p = 0.03) had a significantly worse BCVA. CONCLUSIONS: Our data suggest that AMD-related PPCNV with greater foveal thickness, PED size, SHRM, and SRF areas have worse final BCVA prognosis.

Ocular Trauma Caused by Confetti Cannons.

BACKGROUND: Eye trauma is an unfortunate and often preventable cause of vision loss. Confetti cannons are common causes of injury. Awareness of ocular hazards of confetti cannons remains low because of limited reports describing ophthalmic injuries following their use. OBJECTIVES: To describe outcomes of ocular trauma caused by confetti cannons and to increase recognition of their ocular risks. METHODS: A retrospective analysis was conducted of eye injuries caused by confetti cannons presenting to a single medical center between 2016 and 2020. Data collected included age, gender, eye injured, ocular damage, visual outcome, and details of surgeries performed. RESULTS: Overall, six consecutive patients (2 males, mean age 19.5 ± 9.74 years) were identified and studied. In all patients only one eye was injured (3 right eyes) during a private celebration, most commonly (n=5) to a bystander while in the vicinity of a cannon operated by someone else. Most common eye injuries included corneal erosion (n=4), traumatic hyphema (n=4), and retinal edema (n=3). Mean initial logMAR visual acuity in the injured eye was 0.73 ± 0.18, improving to 0.25 ± 0.16 at the final visit (P = 0.125). Two patients underwent eye surgery due to their trauma: one to repair globe penetration and another to undergo intravitreal injection of tissue plasminogen activator and C3F8 for submacular hemorrhage, followed 8 months later by intravitreal bevacizumab injection for choroidal neovascularization. CONCLUSIONS: Confetti cannons pose hazards that can cause severe ocular trauma resulting in permanent vision loss. Increasing awareness of device hazards is necessary to prevent eye injuries.

Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial.

Purpose: Direct selective laser trabeculoplasty (DSLT) is a rapid, noncontact automated procedure performed directly through the limbus without gonioscopy. In this first nonrandomized clinical trial we assessed its safety and ability to reduce intraocular pressure (IOP). Methods: Fifteen patients (15 eyes: 10 with open-angle glaucoma [OAG], 4 with ocular hypertension, and 1 with pseudoexfoliation glaucoma), naive or after medication washout, with an IOP ≥22 mm Hg, underwent DSLT by irradiation with 100 or 120 sequential noncontact 532-nm, Q-switched laser shots (0.8-1.4 mJ) automatically applied during 1.5 or 2.3 seconds on the limbus, guided by image analysis and eye tracking. Results were assessed at 1 and 3 hours, 1 day, 1 week, and 1, 3, and 6 months. Results: The mean ± standard deviation baseline IOP (mm Hg) in all eyes was 26.7 ± 2.3. At 1, 3, and 6 months, this value was significantly reduced to 21.7 ± 4.2 (by 18.1%), to 20.8 ± 2.5 (by 21.4%), and to 21.5 ± 4.1 (by 18.8%), respectively. In six patients treated with 1.4 mJ/shot, the mean IOP at 6 months decreased from 26.7 ± 3.2 to 19.3 ± 2.0 (27.1%, P = 0.03). There was a significant reduction in hypotensive medications (from 1.6 ± 1.0 to 0.4 ± 0.7, P = 0.03). No serious adverse events occurred. Conclusions: Automated DSLT appears to be an effective and safe noncontact, rapid modality for reducing IOP in patients with OAG. Higher energy usage led to better results. Translational Relevance: Studying laser transmission through sclera enabled laser irradiation of the trabeculum without gonioscopy.

The effect of trabeculectomy and glaucoma drainage device implantation on postural intraocular pressure changes in glaucomatous eyes.

PURPOSE: To investigate the effect of trabeculectomy and glaucoma drainage device implantation on posture related intraocular pressure (IOP) changes in glaucomatous eyes. METHODS: Eyes in this prospective study were divided into three groups: those that underwent Ahmed glaucoma valve implantation (Ahmed group), those that underwent trabeculectomy with mitomycin C (trabeculectomy group) and those treated medically (medication group). IOP was measured in the sitting position, and after 15 min in the left lateral decubitus position using a Tonopen XL, and a Goldmann applanation tonometer (GAT). For GAT measurements in the left lateral decubitus position, we used a specialized system comprised of a motorized bed attached to a modified slit-lamp table. RESULTS: 111 eyes of 64 glaucoma patients were included in the analysis: 19 in the Ahmed group, 46 in the trabeculectomy group and 46 in the medication group. The difference in IOP between the sitting and supine positions was significant in the medication (2.23 mmHg) and trabeculectomy (1.48 mmHg) groups, but not in the Ahmed group (0.53 mmHg). This significance was reached with the GAT, but not with the Tonopen. A rise of 5 mmHg or more between the sitting and supine positions was documented in 5.2%, 4.3% and 15.2% of eyes in the Ahmed, trabeculectomy and medication groups, respectively. Intraclass correlation coefficient for IOP measurements in the supine position demonstrated good correlation between the two tonometers. CONCLUSIONS: Ahmed valve surgery significantly reduces postural IOP response as compared with medically treated controls. There was no significant difference between Ahmed valve and trabeculectomy in terms of their effect on the postural IOP change.

The association between toxic anterior segment syndrome and intraocular pressure.

PURPOSE: To investigate the association between toxic anterior segment syndrome (TASS) and intraocular pressure (IOP). METHODS: This is a retrospective, controlled, single-site study. Patients who developed TASS following a clear corneal incision cataract surgery in Rabin Medical Center (Petah Tikva, Israel), between the years 2010-2018, were enrolled. The primary outcome was IOP measured 1, 7 (± 2), and 30 (± 7) days after surgery. The need for ocular hypotensive treatment was the secondary outcome. RESULTS: The study and control groups included 374 and 127 eyes, respectively. The mean IOP in the study and the control groups were 16.3 ± 7.1 and 15.3 ± 3.0 (p = 0.02) at day 1, 13.2 ± 5.0 and 13.7 ± 2.9 (p = 0.18) at day 7, and 13.7 ± 4.1 and 13.5 ± 2.8 (p = 0.65) at day 30. Prevalence of high IOP (> 21 mmHg) was significantly higher in the study group solely on the first postoperative day (12.7% and 3.2%, p = 0.002). In the study group, 9%, 3.7%, and 1.6% of the patients required hypotensive medications at day 1, 7, and 30, respectively. Four patients (~ 1%) in the study group developed acute angle closure due to pupillary block, 1-3 weeks after surgery and required laser iridotomy and topical treatment. CONCLUSION: High IOP is considered a concerning characteristic of the late stages of TASS although such association lack supporting evidence. This study did not detect such an association. High IOP was found only in a small group of TASS patients in the early perioperative period.

Diagnosis of Pseudoexfoliation Syndrome in Pseudophakic Patients.

OBJECTIVE: The aim of this study was to evaluate the sensitivity and specificity of pseudoexfoliation syndrome diagnosis in pseudophakic patients and potential means of improving it. METHODS: This prospective, nonrandomized study comprised 41 consecutive patients (41 eyes) scheduled for cataract surgery at a tertiary medical center during 2016 and 2017. Preoperatively, all patients underwent a detailed slit-lamp examination, including gonioscopic assessment of the iridocorneal angle. The examination was performed by a glaucoma specialist who completed an assessment form documenting the presence/absence of clinical signs of pseudoexfoliation syndrome. It was repeated 1-2 weeks postoperatively by a second, masked, glaucoma specialist. RESULTS: Sixteen patients (39.0%) were diagnosed with pseudoex-foliation syndrome preoperatively. The diagnosis was confirmed postoperatively in 11/16 patients (68.8% sensitivity) and in an additional patient not diagnosed preoperatively (96% specificity). The ability to diagnose pseudoexfoliation syndrome postoperatively was significantly worse than preoperatively (Z = 12.161, p < 0.0001). Pupillary border deposits (75% of cases) and the Sampaolesi line (83.3%) were the cornerstones of the postoperative diagnosis; anterior capsular deposits were evident in only 41.6% of cases diagnosed postoperatively (31.3% of the originally diagnosed cases). CONCLUSIONS: Underdiagnosis of pseudoexfoliation syndrome is common in pseudophakic patients and may have significant implications for future management. Careful attention to pupillary border anatomy and meticulous gonioscopic assessment of the iridocorneal angle are essential for accurate diagnosis. Preoperative documentation of pseudoexfoliation syndrome could help prevent this diagnostic pitfall.

Changes in Prices and Eye-Care Providers Prescribing Patterns of Glaucoma Medications in the United States Between 2013 and 2019.

PRECIS: Brand glaucoma medication prices vastly increased in the United States over the past 7 years, despite a reduction in eye-care providers' tendency to prescribe brand medications over generics. PURPOSE: Determine the changes in prices of brand and generic glaucoma medications and to identify changes in eye-care providers prescribing patterns since 2013. MATERIALS AND METHODS: The National Average Drug Acquisition Cost (NADAC) database (2013-2019) was used analyze per-unit drug price. Medicare Part D prescriber profile was used to identify eye-care providers prescribing patterns between 2013 and 2017. RESULTS: Brand-name medication prices increased by 59% between 2013 and 2019, while generic medications decreased by 22%. Brand-name drugs were 13 to 162 times more expensive than their generic counterparts. Eye-care Providers prescribed 25% less brand name medications in 2017 compared with 2013. CONCLUSION: Brand glaucoma medication prices vastly increased in the United States over the past 7 years, despite a reduction in eye-care providers' tendency to prescribe brand medications over generics. A change in government policy, allowing Medicare medication prices negotiations, could greatly reduce health expenditure on glaucoma treatment.

MIMS Procedure: Concept and Evaluation of Safety, Feasibility, and Efficacy in a Porcine Experimental Model.

PRECIS: We present a novel stentless filtration system used to create a permanent sclerocorneal drainage channel that reduces intraocular pressure (IOP) without the need to create a conjunctival incision or a scleral flap. PURPOSE: The purpose of this study was to evaluate the safety, feasibility, and preliminary performance of a novel surgical system, the minimally invasive micro sclerostomy (MIMS), in an in vivo porcine experimental model. MATERIALS AND METHODS: MIMS is an ab externo stentless filtration procedure. An activation system is used to operate a handpiece that includes a 600 µm needle containing an injectable 300 µm triangular blade that spins around its longitudinal axis. The needle is inserted into the subconjunctival space and the blade is injected at the limbal area creating a drainage channel at the sclerocorneal junction, connecting the anterior chamber to the subconjunctival space. The first generation of the MIMS surgical system was assessed in a porcine experimental model, firstly on 6 pigs and thereafter on 10 pigs. All adverse events, IOP measurements, and bleb descriptions were recorded for up to 14 weeks. The shape and location of the scleral tunnel, the subconjunctival bleb, and the healing process were examined by slit-lamp examination, by histopathologic analysis, and by anterior segment optical coherence tomography imaging. RESULTS: No device malfunctions were recorded. Scleral tunnels were repeatedly achieved in all models. No significant intraoperative or postoperative complications were recorded. Effective fluid percolation was achieved in all eyes. The mean IOP statistically significantly decreased from 19.0±3.2 mm Hg preoperatively to 11.1±4.9 mm Hg on the first follow-up visit (P=0.0046) in the first leg of the study, and from 18.5±3.8 to 13.3±1.9 mm Hg in the second leg (P=0.0165). In both, IOP gradually returned to preoperative values toward the end of the follow-up period, as expected in a porcine experimental model. Histologic analysis of the analyzed tissue was not associated with significant tissue reaction. CONCLUSIONS: The MIMS procedure exhibited a consistent and relatively high safety, feasibility, and efficacy profiles. In the future, the MIMS procedure may provide a novel solution for uncontrolled IOP.

Non-contact direct selective laser trabeculoplasty: light propagation analysis.

Selective laser trabeculoplasty (SLT), used to treat glaucoma and ocular hypertension, requires the use of a gonioscope placed on the cornea to visualize and irradiate the trabecular meshwork (TM). Alternatively, non-contact direct SLT (DSLT) irradiates the TM through the overlying tissues. Here we analyze this innovative procedure using analytical modeling and Monte Carlo simulations to quantify the laser energy reaching the TM through the overlying tissues. Compared with energy launched from the laser, DSLT energy transmission to the TM is 2.8 times less than SLT, which verifies the efficacy of non-contact DSLT given the lowest reported effective SLT energies.

Effects of Postural Variation on Intra-ocular Pressure: Comparison between Pseudo-exfoliation Glaucoma and Primary Open Angle Glaucoma.

Purpose: to compare the posture-related intraocular pressure (IOP) changes in pseudo-exfoliation glaucoma (PXFG) and in primary open-angle glaucoma (POAG) patients using the EyeOP, a novel Goldmann Applanation Tonometer (GAT) and to investigate the effect of ab externo trabeculectomy on these changes. Methods: Prospective, non-randomized, controlled, observational study. IOP was measured in sitting and in left lateral decubitus positions (LLDP), using GAT, GAT-EyeOP and Tonopen XL. Main Outcome Measure: Posture-related IOP differences between groups. Results: Thirty-two eyes of 32 PXFG patients (21 non-operated, 11 post-trabeculectomy) and 47 eyes of 47 POAG patients (18 non-operated, 29 post-trabeculectomy) were included. Among non-operated patients, the average increase in GAT IOP between positions (∆IOP) was 2 ± 1.86 mmHg for the PXFG group and 1.9 ± 2.84 mmHg for the POAG group (P = .87). The ∆IOP among operated patients (1.72 ± 1.9) was slightly less than in non-operated (1.6 ± 2.69; P = .905). Generally, in the LLDP, the mean difference between GAT and Tonopen XL IOP measurements was 1.9 ± 3.83 mmHg (r = 0.643; P < .001). A similar correlation was demonstrated between tonometers when measured in the sitting position. Conclusions: Both PXFG and POAG patients have increased IOP in LLDP as compared to an upright position, with no statistically significant difference between groups. Trabeculectomy had no significant effect on the ∆IOP. Abbreviations: PXFG: pseudo-exfoliation glaucoma; POAG: primary open-angle glaucoma; IOP: intraocular pressure; GAT: goldmann applanation tonometer; LLDP: left lateral decubitus position; ∆IOP: average increase in IOP between positions; TM: trabecular meshwork; CCT: central corneal thickness; MMC: Mitomycin C.