Characteristics and Treatment Outcomes of Hypotony Maculopathy Post-Glaucoma Filtering Surgery: An Optical Coherence Tomography-Based Study.

PURPOSE: This study assesses morphological characteristics using SD-OCT in patients with hypotony maculopathy (HM) following glaucoma filtering surgery and evaluates the results of its treatment. MATERIAL AND METHODS: Retrospective analysis of all HM patients between January 2019 and March 2023. Inclusion criteria consisted of both pre-operative and post-revision SD-OCT images of the macula and the presence of HM as observed on OCT images preoperatively. HM was graded according to its appearance in OCT both pre- and post-revision surgery. Change in visual acuity and IOP were assessed. RESULTS: 45 eyes of 45 patients were included. 21 eyes had HM limited to retinal pigment epithelium (RPE), 18 eyes had involvement of RPE and photoreceptor layers and 6 eyes had additional intra- or subretinal edema. After revision surgery with IOP elevation, 64% of eyes had complete HM regression with no HM signs in OCT imaging. 80% of patients achieved at least one grade improvement in HM. Preoperative visual acuity increased from 0.7±0.4 (logMAR) to 0.4±0.4 at 2 weeks postoperatively, over the course of an increase of IOP from 3.5±1.8 mmHg to 17.1±10.6 mmHg at day one. Eyes with complete HM regression had higher IOP at day 1 compared to those without improvement (P=0.04). The median time between HM onset and revision was 10.0 days for those with complete regression and 27 days for those without improvement (P=0.04). CONCLUSIONS: Bleb revision procedures for HM following glaucoma filtering surgery show promising outcomes, including notable improvements in visual acuity and IOP. The timing of revision surgery appears to influence outcome. In our study earlier intervention was associated with better results. Even delayed surgeries can lead to an improvement, although complete morphological restoration may not be achieved in advanced grades of HM.

Change of Intraocular Pressure Over 5 Years and its Relationship to Cardiovascular Parameters: Results From the Gutenberg Health Study.

Purpose: To investigate the longitudinal change in intraocular pressure (IOP) over 5 years and its relationship with cardiovascular parameters in a population-based sample in Germany. Methods: The Gutenberg Health Study is a prospective, observational, single-center cohort study. The sample was equally stratified for sex, residence, and age decade. IOP was measured with noncontact tonometry at baseline and at 5-year follow-up. Cardiovascular parameters, including body mass index (BMI), systolic blood pressure, and diabetes status, were assessed. Participants without IOP measurement at one time point, who were taking IOP-lowering medications, or who had ophthalmic surgery during the 5-year follow-up interval were excluded, as well as those with glaucoma diagnosis. Univariable and multivariable linear regression analyses were conducted. Results: This analysis included 9633 participants (48.9% female). The mean IOP increased from 14.04 ± 2.78 mmHg at baseline to 14.77 ± 2.92 mmHg at 5-year follow-up (P < 0.001). In multivariable linear regression analyses, an increase in BMI was associated with an increase in IOP over time (P < 0.001), whereas a higher baseline BMI was associated with a lower IOP change (P < 0.001). Higher age and male sex were associated with higher IOP change (P < 0.001). A change in systolic blood pressure was associated with IOP change, whereas baseline systolic blood pressure and diabetes status were not associated. Conclusions: This population-based study found a relationship between IOP change over 5 years and BMI and systolic blood pressure change, respectively. These findings suggest the importance of monitoring cardiovascular risk factors in IOP management.

[Real-world outcomes of glaucoma surgical procedures for open-angle glaucoma]. / Real-world-Ergebnisse von glaukomchirurgischen Verfahren beim Offenwinkelglaukom.

This article provides an overview of real-world outcomes in glaucoma surgical procedures. While randomized clinical trials provide valuable insights, they do not fully reflect real-world clinical practice. Real-world studies enable the evaluation of outcomes in uncontrolled settings and play a crucial role in counselling and decision-making for glaucoma treatment. By examining real-world data the article aims to identify rare adverse events that may go unnoticed in controlled clinical trials. The focus is on assessing the effectiveness and safety of glaucoma surgical procedures beyond the controlled trial setting.

Influence of different primary surgical techniques on long-term intraocular pressure and medication in glaucoma after congenital cataract surgery.

PURPOSE: To assess long-time results of primary surgical treatment in children with glaucoma after congenital cataract surgery. METHODS: A retrospective study of 37 eyes from 35 children with glaucoma after congenital cataract surgery, who underwent surgery between 2011 and 2021 at the Childhood Glaucoma Center, University Medical Center Mainz, Germany. Only children, who received a primary glaucoma surgery in our clinic within the given time (n = 25) and had at least one-year follow-up (n = 21), were included in the further analysis. The mean follow-up time was 40.4±35.1 months. The primary outcome was the mean reduction in IOP (in mmHg) from baseline to follow-up visits after the surgery, measured with Perkins tonometry. RESULTS: 8 patients (38%) were treated with probe trabeculotomy (probe TO), 6 (29%) with 360° catheter-assisted trabeculotomy (360° TO) and 7 (33%) with cyclodestructive procedures. IOP was significantly reduced after probe TO and 360° TO after 2 years, from 26.9 mmHg to 17.4 mmHg (p<0.01) and 25.2 mmHg to 14.1 mmHg (p<0.02), respectively. There was no significant IOP reduction after cyclodestructive procedures after 2 years. Both, probe TO and 360° TO led descriptively to eye drops reduction after 2 years, from 2.0 to 0.7 and 3.2 to 1.1. The reduction was not significant. CONCLUSIONS: In glaucoma after congenital cataract surgery, both trabeculotomy techniques, lead to good reduction of IOP after 2 years. There is a need for a prospective study with comparison to the use of glaucoma drainage implants.

Outcomes of Open Bleb Revision After PreserFlo MicroShunt Failure in Patients With Glaucoma.

PRCIS: After the open bleb revision following PreserFlo, the mean postoperative intraocular pressure (IOP) was lowered from 26.4 ± 9.9 mm Hg to 12.9 ± 5.6 mm Hg at 1 month and 15.9 ± 4.1 mm Hg at 12 months. PURPOSE: The purpose of this study was to evaluate the effectiveness and safety of an open bleb revision with mitomycin- C (MMC) for bleb fibrosis after PreserFlo MicroShunt implantation. PATIENTS AND METHODS: We performed a retrospective analysis of 27 consecutive patients with bleb fibrosis after PreserFlo MicroShunt Implantation that underwent an open revision with MMC 0.2 mg/mL applied for 3 minutes at the Department of Ophthalmology of the Mainz, University Medical Center, Mainz, Germany. Demographic data, such as age, sex, glaucoma type, number of glaucoma medications, IOP before and after PreserFlo implantation and revision, complications, and reoperations within 12 months, were analyzed. RESULTS: Twenty-seven patients (27 eyes) received an open revision after previous PreserFlo Microshunt implantation and consecutive bleb fibrosis. The mean preoperative IOP was 26.4 ± 9.9 mm Hg before revision, 7.0 ± 2.7 mm Hg ( P < 0.001) in the first week after the revision, and 15.9 ± 4.1 mm Hg at 12 months ( P = 0.02). Four patients needed IOP-lowering medication after 12 months. One patient had a positive Seidel test and needed a conjunctival suture. Four patients required a second procedure due to recurring bleb fibrosis. CONCLUSIONS: At 12 months, open revision with MMC for bleb fibrosis after failed PreserFlo implantation effectively and safely reduced IOP with a similar medication burden.

Coarsened Exact Matching of Excisional to Plasma-ablative Ab Interno Trabeculectomy.

Aim: To compare ab interno trabeculectomy by trabecular meshwork (TM) excision to plasma-mediated ablation in primary open-angle glaucoma (POAG) patients. Methods: Retrospectively collected data of TrabEx+ (TEx) (n = 56) and Trabectome (T) (n = 99) patients were compared by coarsened exact matching to reduce confounding and matched based on baseline intraocular pressure (IOP) and age. The primary outcomes were IOP and the number of glaucoma medications. Complications and the need for additional glaucoma surgery were assessed. Patients were followed for up to 1 year. Results: A total of 53 TEx could be matched to T. Baseline IOP was 16.5 ± 4.6 mm Hg in both; age was 73.7 ± 8.8 and 71.5 ± 9.9 years in TEx and T, respectively. TEx was taking more medications than T (p < 0.001). IOP was reduced to 14.8 ± 4.3 in TEx and to 13.4 ± 3.4 in T at 6 months, and to 14.9 ± 6.0 (p = 0.13) in TEx and to 14.1 ± 3.8 mm Hg (all p < 0.05) in T at 12 months. Medications were reduced at both 6 and 12 months (p < 0.05). No differences were seen between TEx and T at 6 and 12 months. In TEx, only one serious complication occurred, and two patients required further glaucoma surgery. Conclusion: Although both groups had a baseline IOP considered low for ab interno trabeculectomy, IOP and medications were reduced further at 6 and 12 months. IOP reduction did not reach significance in TEx at 12 months. The intergroup comparison did not reveal any significant differences. Both had a low complication rate. Clinical significance: This study investigated subtle differences between a plasma-ablative device, the T, and an excisional device, the TEx, by applying coarsened exact matching. IOP and medications were reduced in both groups at 6 and 12 months, although IOP reduction did not reach significance in TEx at 12 months. The intergroup comparison did not reveal any significant differences, with both devices having a low complication rate. How to cite this article: Dakroub M, Verma-Fuehring R, Strzalkowska A, et al. Coarsened Exact Matching of Excisional to Plasma-ablative Ab Interno Trabeculectomy. J Curr Glaucoma Pract 2023;17(1):9-14.

Tissue-engineered anterior segment eye cultures demonstrate hallmarks of conventional organ culture.

BACKGROUND: Glaucoma is a blinding disease largely caused by dysregulation of outflow through the trabecular meshwork (TM), resulting in elevated intraocular pressure (IOP). We hypothesized that transplanting TM cells into a decellularized, tissue-engineered anterior segment eye culture could restore the outflow structure and function. METHODS: Porcine eyes were decellularized with freeze-thaw cycles and perfusion of surfactant. We seeded control scaffolds with CrFK cells transduced with lentiviral vectors to stably express eGFP and compared them to scaffolds seeded with primary TM cells as well as to normal, unaltered eyes. We tracked the repopulation behavior, performed IOP maintenance challenges, and analyzed the histology. RESULTS: Transplanted cells localized to the TM and progressively infiltrated the extracellular matrix, reaching a distribution comparable to normal, unaltered eyes. After a perfusion rate challenge to mimic a glaucomatous pressure elevation, transplanted and normal eyes reestablished a normal intraocular pressure (transplanted = 16.5 ± 0.9 mmHg, normal = 16.9 ± 0.9). However, eyes reseeded with eGFP-expressing CrFK cells could not regulate IOP, remaining high and unstable (27.0 ± 6.2 mmHg) instead. CONCLUSION: Tissue-engineered anterior segment scaffolds can serve as readily available, scalable ocular perfusion cultures. This could reduce dependency on scarce donor globes in outflow research and may allow engineering perfusion cultures with specific geno- and phenotypes.

[Why trabeculectomy is better than its reputation]. / Warum die Trabekulektomie besser ist als ihr Ruf.

BACKGROUND: Trabeculectomy (TE) remains one of the most frequently performed glaucoma procedures. This surgery enables sufficient reduction of intraocular pressure (IOP) and freedom from using eye drops; however, complication management and time-consuming postoperative care make many ophthalmic surgeons reluctant to include TE in their treatment regimen. AIM: This review presents the value of TE compared to other forms of filtering and nonfiltering glaucoma surgery. CONCLUSION: The use of TE is still the most effective method for lowering IOP and in comparison to other forms of glaucoma surgery in most cases enables freedom from eye drops with a subsequent high quality of life. Postoperative complications occur more frequently, but usually heal spontaneously or can be treated adequately and safely by surgery; however, TE requires intensive postoperative care, which should not be neglected. Repeated surgery due to insufficient IOP reduction is less frequent compared to other forms of glaucoma surgery.

A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt® Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension.

Background: The aim of this study was to demonstrate the equivalence of generic dorzolamide 2% eye drops solution versus the innovator formulation (Trusopt® eye drops solution) in patients with open-angle glaucoma or ocular hypertension. Methods: This prospective, monocentric, double-masked, active-controlled crossover phase III study included 32 patients. After washout, patients were randomized to reference product (Trusopt®) or test product (dorzolamide 2% eye drops, Rompharm Company SRL) for a 4-week period. Subsequent washout and crossover were performed. Drops were applied t.i.d. The primary efficacy endpoint was the difference in mean diurnal IOP. Goldmann applanation tonometry was performed at 8 am, 12 pm, and 4 pm at each visit, and safety was assessed by documentation of adverse events (AEs). Therapy adherence was documented by self-reporting and eye drop bottle weighing. An ANOVA with treatment, sequence, study period, and patient within the sequence as effects was performed and an additional post hoc ANCOVA including the baseline IOP was also performed. Results: 34 patients were randomized and analyzed in the safety population. The per-protocol population included 32 patients. According to the self-report, all patients were >80% compliant. Under the ANCOVA model, the 90% confidence interval for the average change of the IOP -0.27 mmHg (-1.17 mmHg-0.64 mmHg) is included by the acceptance range -1.5 mmHg to +1.5 mmHg after excluding 2 patients, which had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments. Conclusions: This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution. Trial Registration. This trial is registered with (ClinicalTrials.gov (identifier: NCT00878917) on April 9, 2009).

Intraocular Pressure Measurement in Childhood Glaucoma under Standardized General Anaesthesia: The Prospective EyeBIS Study.

Objective: We aimed to compare intraocular pressure (IOP) measurements using iCare® PRO rebound tonometry (iCare) and Perkins applanation tonometry (Perkins) in childhood glaucoma subjects and healthy children and the influence of anaesthesia depth, age and corneal thickness. Material: Prospective clinical, case-control study of children who underwent an ophthalmologic examination under general anaesthesia according to our protocol. Children were 45.45 ± 29.76 months old (mean ± SD (standard deviation)). Of all children, 54.05% were female. IOP was taken three times (T1−T3), according to duration and the depth of anaesthesia. The order of measurement alternated, starting with iCare. Agreement between the device measurements was evaluated using Bland−Altman analysis. Results: 53 glaucoma subjects and 22 healthy controls. Glaucoma subjects: IOP measured with iCare was at T1: 27.2 (18.1−33.8), T2: 21.6 (14.8−30.6), T3: 20.4 mmHg (14.5−27.0) and Perkins 17.5 (12.0−23.0), 15.5 (10.5−20.5), 15.0 mmHg (10.5−21.0) (median ± IQR (interquartile range)). Healthy controls: IOP with iCare: T1: 13.3 (11.1−17.0), T2: 10.6 (8.1−12.4), T3: 9.6 mmHg (7.7−11.7) and Perkins 10.3 (8.0−12.0), 7.0 (5.5−10.5), 7.0 mmHg (5.5−8.5) (median ± IQR). The median IOP was statistically significantly higher with iCare than with Perkins (p < 0.001) in both groups. The mean difference (iCare and Perkins) was 6.0 ± 6.1 mmHg for T1−T3, 7.3 at T1, 6.0 at T2, 4.9 mmHg at T3. Conclusion: The IOP was the highest in glaucoma subjects and healthy children at T1 (under sedation), independently of the measurement method. iCare always leads to higher IOP compared to Perkins in glaucoma and healthy subjects, regardless of the duration of anesthesia.

Comparison of a second-generation trabecular bypass (iStent inject) to ab interno trabeculectomy (Trabectome) by exact matching.

PURPOSE: To achieve a highly balanced comparison of trabecular bypass stenting (IS2, iStent inject) with ab interno trabeculectomy (T, Trabectome) by exact matching. METHODS: Fifty-three IS2 eyes were matched to 3446 T eyes. Patients were matched using exact matching by baseline intraocular pressure (IOP), the number of glaucoma medications, and glaucoma type, and using nearest neighbor matching by age. Individuals without a close match were excluded. All surgeries were combined with phacoemulsification. RESULTS: A total of 78 eyes (39 in each group) could be matched as exact pairs with a baseline IOP of 18.3 ± 5.1 mmHg and glaucoma medications of 2.7 ± 1.2 in each. IOP in IS2 was reduced to 14.6 ± 4.2 mmHg at 3 months and in T to a minimum of 13.1 ± 3.2 mmHg at 1 month. In IS2, IOP began to rise again at 6 months, eventually exceeding baseline. At 24 months, IOP in IS2 was 18.8 ± 9.0 mmHg and in T 14.2 ± 3.5 mmHg. IS2 had a higher average IOP than T at all postoperative visits (p < 0.05 at 1, 12, 18 months). Glaucoma medications decreased to 2.0 ± 1.5 in IS2 and to 1.5 ± 1.4 in T. CONCLUSION: T resulted in a larger and sustained IOP reduction compared with IS2 where a rebound occurred after 6 months to slightly above preoperative values.

Results of First In Vivo Trial of an Acoustic Self-Tonometer.

Purpose: Glaucoma is the world's most common cause of irreversible blindness, which makes early diagnosis, with the goal of preserving vision, essential. The current medical intervention is to reduce intraocular pressure (IOP) to slow down progression of the disease. The main goal of this study was to test a novel handheld acoustic self-tonometer on humans. Methods: A sound pressure pulse generated by a loudspeaker causes the eye to vibrate. A pressure chamber is placed on the human orbit to form a coupled system comprised of the patient's eye, the enclosed air, and the loudspeaker. A displacement sensor in front of the loudspeaker membrane allows the dynamic behavior of the entire system to be detected. Results: For this clinical trial series, a prototype of the acoustic self-tonometer principle was applied. The resulting membrane oscillation data showed sensitivity of patient IOP, but direct allocation of the measured damping and frequency to the IOP was not significant. For this reason, an artificial neural network was used to find relationships among the subjects' biometric eye parameters in combination with the self-tonometer data for the IOP reference. An expanded measurement uncertainty (kp = 2) equal to 6.53 mm Hg was determined for the self-tonometer in a Bland-Altman analysis using Goldmann applanation tonometer reference measurements. Conclusions: The usability and success rate of producing valid measurement values with the device during self-measurements by test subjects was nearly 92%. The cross-sensitivities observed require compensation in a possible redesign phase to reduce the measurement uncertainty by at least 25% to the maximum of 5 mm Hg required to seek medical device approval. Translational Relevance: Building on successful laboratory experiments with pig eyes, this article reports the results of testing the acoustic tonometer on humans.

Retrospective evaluation of two-year results with a filtering trabeculotomy in comparison to conventional trabeculectomy by exact matching.

Background: To compare two-year results of a filtering trabeculotomy (FTO) to conventional trabeculectomy (TE) in open-angle glaucoma by exact matching. Methods: 110 patients received an FTO and 86 a TE. FTO avoided the need for an iridectomy due to a preserved trabeculo-descemet window anterior to the scleral flap. TE employed a trabecular block excision and iridectomy. Mitomycin C was used in both. FTO and TE were exact matched by baseline intraocular pressure (IOP) and the number of glaucoma medications. Complete and qualified success (IOP ≤18 mmHg and IOP reduction ≥ 30%, with or without medication) were primary endpoints. IOP, visual acuity (BCVA), complications and intervention were secondary endpoints. Results: 44 FTO were exact matched to 44 TE. The IOP baseline in both groups was 22.5±4.7 mmHg on 3±0.9 medications. At 24 months, complete success was reached by 59% in FTO and 66% in TE, and qualified success by 59% in FTO and 71% in TE. In FTO, IOP was reduced to 12.4±4.3 mmHg at 12 months and 13.1±4.1 mmHg at 24 months. In TE, IOP was 11.3±2.2 mmHg at 12 months and 12.0±3.5 mmHg at 24 months. Medications could be reduced at 24 months to 0.6±1.3 in FTO and 0.2±0.5 in TE. There were no significant differences between the two groups in IOP, medications, complications or interventions at any point. Conclusion: Modifying aqueous flow through a limited trabeculotomy in FTO yielded clinical outcomes similar to traditional TE but allowed to avoid an iridectomy.

Combined vitrectomy, near-confluent panretinal endolaser, bevacizumab and cyclophotocoagulation for neovascular glaucoma - a retrospective interventional case series.

Background: Neovascular glaucoma (NVG) is a severe, potentially blinding disease and a therapeutic challenge. The purpose of this study was to evaluate the safety and efficacy of an integrative surgical approach to neovascular glaucoma. Methods: Retrospective analysis of a one-year follow-up of a consecutive interventional case series of NVG. Eyes underwent transscleral cyclophotocoagulation, pars plana vitrectomy, near-confluent panretinal photocoagulation, and intravitreal bevacizumab. Phakic eyes underwent concomitant cataract surgery. Best-corrected visual acuity (BCVA, logMAR), intraocular pressure (IOP, mmHg), number of glaucoma medication, visual analog pain scale (VAPS, 0-10) were recorded at baseline, and 1, 3, 6, and 12 months. Blind eyes were excluded. Results: Seventy-seven eyes of 77 patients (45 male, 32 female, mean age 73.6±12.2 years) were included. NVG underlying conditions included retinal vein occlusion (41.6%), proliferative diabetic retinopathy (35.1%), central retinal artery occlusion (19.5%), and ocular ischemic syndrome (3.9%). Mean IOP decreased postoperatively from 46.3±10.1 mmHg to 14.5±7.9 mmHg (p<0.001), glaucoma medication from 4.7±1.3 to 1.8±1.8 (p<0.001), and VAPS from 6.0±1.8 to 0. BCVA remained unchanged. Postoperative intraocular inflammation had resolved in all eyes at the one-month follow-up. 71.4% (55/77) eyes did not require additional major interventions during follow-up. Conclusions: A single, comprehensive surgery session lowered IOP significantly, reduced GMS, and controlled pain.