Results of open bleb revision as management of primary bleb failure following XEN 45 gel stent and Preserflo™ Microshunt.

PURPOSE: The success of filtering surgery as in XEN-Gel-Stent (XEN) and Preserflo-Microshunt (PF) depends mainly on a functioning bleb. Primary bleb failure (PBF) is not uncommon and can be treated with needling or open bleb revision (OBR). The aim of the study is to compare surgical outcomes of OBR after XEN and PF. METHODS: Eyes which received OBR as management of PBF following implantation of XEN or PF were retrospectively included. Intraocular pressure (IOP), number of IOP lowering medications (NoM), and success rates (SR) were compared between groups. Complete and qualified success were defined as IOP ≤18mmHg and a reduction of >20%, without and with medications, respectively. RESULTS: 29 eyes after XEN and 23 eyes after PF were included. Six months following OBR, IOP reduced from 24.2±4.7 to 13.5±4.6 after XEN and from 27.3±8.7 to 15.9±5.8mmHg after PF (both p<0.001). NoM did not change (0.7±1.3 to 0.4±0.8 after XEN and 1.2±1.3 to 1.0±1.5 after PF, p>0.05 for both). Complete SR were higher after XEN than after PF (58.6% vs. 30.4%, p=0.04). Complications were mild and managed mainly conservatively. Additional glaucoma surgery was needed in 17% and 30% of eyes after XEN and PF, respectively (p=0.26). CONCLUSION: Although OBR was effective as management of PBF following XEN and PF, SR were higher after XEN than after PF along with comparable safety profile. The change of the surgical approach from ab interno during XEN-Implantation to ab externo during OBR seems to enhance SR compared to PF, where both interventions are done ab externo.

Outcome of a single XEN microstent implant for glaucoma patients with different types of glaucoma.

BACKGROUND: The aim of this retrospective study was to compare the efficacy and safety profile of a single XEN-microstent in different types of primary and secondary open angle glaucoma. METHODS: A single XEN microstent was implanted in patients with primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), pseudoexfoliation glaucoma (PEX) and secondary glaucoma (Sec.Gl). The intraocular pressure (IOP), the active substances of the applied IOP-lowering drugs, the best corrected visual acuity (BCVA) and the mean deviation (MD) of the perimetry were measured at baseline and at regular follow-ups, scheduled at 2 days and 1, 3, 6 and 12 months after surgery. RESULTS: 153 eyes were included in this analysis. 113 eyes were affected by POAG (74%), 5 eyes by NTG (3%), 22 eyes by PEX (14%) and 13 eyes by Sec. Gl (9%). Mean IOP decreased in all treatment groups during the 12 months of follow-up (complete group: 23.9 ± 7.4 to 15.4 ± 5.1 mmHg (p < 0.01); POAG: 22.8 ± 6.5 to 15.1 ± 4.6 mmHg (p < 0.01); NTG: 16.6 ± 3.4 to 11.6 ± 2.2 mmHg (p < 0.05); PEX: 28.0 ± 7.9 to 17.1 ± 6.6 mmHg (p < 0.01); Sec.Gl: 28.9 ± 13.9 to 15.5 ± 6.9 mmHg (p < 0.05)). In the 153 eyes the average number of IOP-lowering drugs applied decreased from 2.6 ± 1.2 to 0.8 ± 1.3 12 months after surgery (p < 0.01). BCVA and mean deviation of automated standard perimetry remained stable in all groups during follow-up. CONCLUSION: As in eyes suffering from POAG, IOP and number of IOP-lowering drugs applied can be effectively reduced by XEN implantation in eyes suffering from NTG, PEX and secondary glaucoma while leaving BCVA and visual field unchanged. TRIAL REGISTRATION: Trial was registered at DRKS (registration number: DRKS00020800 , Registered 25.February 2020 - Retrospectively registered).

[Analysis of Glaucomatous Changes of the Macula Using Optical Coherence Tomography]. / Analyse glaukombedingter Makulaveränderungen mittels optischer Kohärenztomografie.

BACKGROUND: In glaucoma, progressive retinal nerve fibre loss can be measured in the peripapillary and macular regions using optical coherence tomography (OCT). The goal of this study was to evaluate the impact of glaucoma on all measureable retinal layers using the spectral domain OCT (SD-OCT). MATERIALS AND METHODS: SD-OCT scans using automated retinal layer segmentation were performed in both eyes of primary open-angle glaucoma patients with strictly monocular absolute visual field scotoma in the central 10° of their visual field. The same measurements were performed in one eye per person in a healthy age-matched control group. The mean thickness of all retinal layers in the central 24 × 24° of the macular region was compared between groups. RESULTS: SD-OCT scans were performed in 24 eyes of 12 glaucoma patients (10 female, 2 male) with a mean age of 72.3 ± 8.1 years and in 12 eyes of 12 healthy controls (9 female, 3 male) with a mean age of 66,0 ± 7,6 years. Statistically significant thickness differences between the glaucomatous and the healthy eyes could be demonstrated for the retinal nerve fibre layer, the ganglion cell layer, the inner plexiform layer and the complete retinal thickness, with lower mean thicknesses in the glaucoma group. CONCLUSION: Using SD-OCT, single retinal layers of the macular region can be scanned and measured automatically. In glaucoma, a decrease in thickness of the inner retinal layers containing ganglion cells and their axons or dendrites could be demonstrated compared to healthy eyes. No corresponding difference in thickness could be found for the outer retinal layers using SD-OCT measurements.

Comparing the efficacy of trabeculectomy and diode laser cyclophotocoagulation in primary open-angle glaucoma.

PURPOSE: The aim was to compare the postsurgical outcomes of trabeculectomy (TET) and transscleral cyclophotocoagulation (CPC) in a similar cohort of eyes diagnosed with primary open-angle glaucoma (POAG). MATERIALS AND METHODS: For this monocentric non-randomized retrospective comparative trial, the records of eyes which underwent TET or CPC between 2013 and 2016 at our institution for the treatment of POAG were reviewed. Parameters analyzed before surgery as well as 1 and 2-3 years afterwards were visual acuity (VA), intraocular pressure (IOP), mean defect (MD) of the visual field, number of glaucoma medications and the objective refraction using which the surgically induced astigmatism (SIA) was calculated. RESULTS: In total, 51 eyes of 51 patients underwent TET and 45 eyes of 45 patients underwent CPC. Mean VA dropped in both groups on the last follow-up after surgery (TET-group: 0.17 ± 0.17 to 0.23 ± 0.28 logMAR, p = 0.01/CPC-group: 0.22 ± 0.22 to 0.26 ± 0.27 logMAR, p = 0.01). In the TET- and CPC-groups IOP decreased significantly (TET: 24.9 ± 6.4 to 14.9 ± 3.1 mmHg, p = 0.001/CPC: 23.0 ± 6.5 to 16.0 ± 4.1 mmHg, p = 0.001) although more pronounced and less depending on IOP-lowering medication in eyes after TET. MD remained stable after TET (7.4 ± 4.8 and 8.1 ± 4.9 dB, p = 0.1) but further deteriorated in eyes after CPC (9.0 ± 4.9 and 10.7 ± 4.6 dB, p < 0.001). SIA was comparable in both groups on the last follow-up (TET: 0.83 ± 0.69 D; CPC: 0.91 ± 0.65 D, p = 0.6). CONCLUSION: The IOP reduction achieved without medication was more pronounced in the TET-group compared with the CPC-group. Visual field remained stable in the TET-group, while further deteriorating in the CPC-group during follow-up. Eyes undergoing CPC had a higher demand for additional medication to reach comparable success rates as TET. Due to this performing TET is favorable over CPC in POAG eyes.

A Comparative Analysis of Morphology and Dimensions of Functional Blebs following PRESERFLO-Microshunt and XEN-Gel-Stent, a Study Using Anterior Segment OCT.

Evaluation of bleb morphology is a vital part of successful filtration glaucoma surgery. The PRESERFLO-MicroShunt (PRESERFLO) and XEN-Gel-Stent (XEN) are drainage devices implanted using different surgical approaches (ab externo and ab interno, respectively), potentially resulting in distinct bleb morphology. Understanding these morphological differences is essential for postoperative care. In this study, we retrospectively examined functioning blebs following PRESERFLO and XEN implantation using high-resolution anterior segment OCT imaging. Qualitative assessment utilizing the Jenaer Bleb Grading System and quantitative assessment measuring 12 parameters representing bleb dimensions were conducted, and the results were compared between the two groups. A total of 80 eyes from 80 patients were included (41 after PRESERFLO, 39 after XEN). Functioning blebs following PRESERFLO exhibited a higher frequency of hyperreflective tenon changes compared to XEN (31.7% vs. 10.3%, respectively, p = 0.02) and a lower frequency of cavernous changes (17.1% vs. 35.9%, p = 0.05). Additionally, PRESERFLO blebs showed a higher frequency of visible episcleral lakes (92.7% vs. 30.8%, p < 0.001). Furthermore, PRESERFLO blebs demonstrated larger height (2.13 ± 0.5 vs. 1.85 ± 0.6 mm, p = 0.03), width (10.31 ± 2.3 vs. 9.1 ± 2.3 mm, p = 0.02), length (9.13 ± 1.8 vs. 8.24 ± 1.9 mm, p = 0.04), posterior location relative to the limbus (6.21 ± 1.2 vs. 5.21 ± 1.8 mm, p = 0.005), and a thicker bleb wall (1.60 ± 0.5 vs. 1.1 ± 0.4 mm, p = 0.004). Functioning blebs following PRESERFLO and XEN displayed morphological distinctions, likely attributed to variations in surgical techniques (ab externo vs. ab interno) and stent dimensions. These morphological differences should be taken into consideration when evaluating blebs, as they could impact assessments of bleb functionality and influence decisions regarding postoperative interventions.

Factors Correlated With Mid-Term Morphology of Functional Blebs Following Implantation of Preserflo MicroShunt Using AS-OCT.

Purpose: Evaluating bleb morphology is crucial after glaucoma filtering surgery. Advances in anterior segment optical coherence tomography (AS-OCT) allow for objective assessment. While various parameters differentiate functional from failed blebs, limited information exists regarding variations within functional blebs. This study aimed to identify factors influencing morphology of functional blebs following implantation of Preserflo MicroShunt. Methods: Eyes with functional blebs after Preserflo were retrospectively included. Age, gender, lens status, preoperative intraocular pressure (pre-IOP) and number of glaucoma medications were documented along with biometric measurements as axial length (AL), white-to-white distance, and anterior chamber depth. Postoperative data included time elapsed since surgery (TaS) and postoperative IOP (post-IOP). Bleb dimensions were measured using AS-OCT including maximal bleb height (MBH), width, length (MBL), bleb wall thickness (BWT), and bleb distance to limbus (DtL) along with dimensions of episcleral lake (maximal height, width [MLW], and length). Linear regression models were applied to correlate these parameters with bleb dimensions. Results: Included were 50 eyes from 50 patients. Mean IOP decreased from 25.3 ± 10.0 to 11.9 ± 3.0 mm Hg after 278.5 ± 221.9 days after surgery. MBH correlated negatively with age (unstandardized coefficients [uSC] = -0.012) and TaS (uSC = -0.001, P = 0.008 for both). BWT correlated negatively with age (uSC = -0.013, P = 0.02), MBL with AL (uSC = -0.566, P = 0.01) and MLW with pre-IOP (uSC = -0.073, P = 0.02). DtL exhibited a positive correlation with post-IOP (uCS = 0.136, P = 0.02). Conclusions: Morphology of functional blebs might be influenced by multiple factors such as age, TaS, AL, and pre- and post-IOP. Translational Relevance: Age, time after surgery, axial length, and preoperative and postoperative IOP could affect the morphology of a functional bleb; hence, these factors should be taken into consideration when making treatment decisions.

Comparison of Bleb Morphology following PRESERFLO® MicroShunt and Trabeculectomy Using Anterior Segment OCT.

Trabeculectomy has traditionally been upheld as the gold standard in glaucoma surgery, but recent advancements, including the PRESERFLO® MicroShunt, have introduced less invasive techniques to mitigate complications and reduce intraocular pressure (IOP). The examination of bleb morphology post-filtering surgery is critical for modulating wound healing and ensuring long-term success. While previous evaluations of PRESERFLO-generated blebs have relied on data from trabeculectomy blebs, the differing surgical techniques used in PRESERFLO and trabeculectomy surgeries suggest potential variations in bleb morphologies. This study conducted a comparative analysis of blebs resulting from PRESERFLO and trabeculectomy procedures. Retrospective descriptive assessments using the Jenaer Bleb Grading System were performed, along with quantitative evaluation using eight-dimensional parameters utilizing anterior segment OCT. We included 93 eyes (57 following PRESERFLO, 36 following trabeculectomy). In the descriptive assessment, PRESERFLO-generated blebs exhibited fewer conjunctival cysts (3.5% vs. 22.2%, p = 0.007) and cavernous changes (10.5% vs. 30.5%, p = 0.021) compared to trabeculectomy. Quantitatively, overall bleb dimensions were comparable (maximal bleb height, width, and length, p > 0.05 for all). However, PRESERFLO blebs displayed a shallower (0.52 ± 0.24 vs. 0.67 ± 0.3 mm, p = 0.017) yet longer (4.12 ± 1.54 vs. 3.23 ± 1.64 mm, p = 0.024) episcleral lake. A thicker bleb wall (1.52 ± 0.46 vs. 1.10 ± 0.37 mm, p < 0.001) along with more posteriorly positioned blebs (distance to limbus = 6.16 ± 1.36 vs. 4.87 ± 1.34 mm, p < 0.001) were observed following PRESERFLO. This study illuminates the nuanced morphological differences between PRESERFLO and trabeculectomy blebs. Understanding these distinctions is vital, empowering clinicians to make informed postoperative decisions and avoid misinterpretation of bleb morphology.

[Bleb morphology using optical coherence tomography : After primary implantation of XEN gel stent and open conjunctival revision]. / Morphologie des Sickerkissens mittels optischer Kohärenztomographie : Nach primärer Implantation von XEN-Gel-Stent und offener Bindehautrevision.

BACKGROUND: The implantation of a XEN gel stent is an innovative method for filtration surgery using an ab interno approach. The morphological evaluation of the resulting bleb is decisive for surgical success. Bleb revision is frequently needed after XEN implantation and might affect the bleb morphology. Aim of this study was to examine bleb morphology using anterior segment OCT (AS-OCT) and analyze the morphological differences of blebs after primary XEN implantation and after bleb revision. MATERIAL AND METHODS: Included were eyes that underwent XEN implantation (Pr-X) or bleb revision after XEN (Re­X group). An AS-OCT of blebs was performed and images were classified using a novel classification system (the Jenaer bleb grading system, JBGS). Frequency of different tomographic patterns (M) and their correlation with intraocular pressure (IOP) were analyzed. RESULTS AND DISCUSSION: A total of 69 eyes (40 in the Pr­X and 29 in the Re­X groups) were included. At the conjunctival level, the most common M in both groups was subconjunctival spaces (M-C2) followed by intraconjunctival cysts (C1) and no conjunctival changes (C0). No differences of frequencies between the two groups or of IOP between the three Ms were seen. At the tenon level, the most commonly seen Ms in the Pr­X group were hyporeflective and cavernous changes (M-T2, T3) followed by no changes (M0) and hyperflective changes (T1). In the Re­X group, the M­T1 and T2 were most commonly seen followed by T3 and T0. The M­T2 and T3 in the Pr­X group and the M­T1 and T2 in the Re­X group correlated with lower IOP. An episcleral lake (M-ES1) was seen significantly less frequently in the Pr­X group compared with Re­X group where it correlated with lower IOP CONCLUSION: The hyperreflective changes at the tenon level and the presence of an episcleral lake were seen more frequently following bleb revision compared with primary XEN implantation and correlated with lower IOP. The interpretation of bleb morphology using AS-OCT should only be done considering the surgical approach used.

Novel Bleb Classification Following Ab Interno Implantation of Gel-Stent Using Anterior Segment Optical Coherence Tomography.

PRCIS: A novel qualitative tomographical classification for bleb after implantation of XEN-Gel-Stent using ab interno approach is presented. Association of anatomic patterns to intraocular pressure (IOP) and success rates (SR) illustrates that anterior segment optical coherence tomography can be useful tool in clinical guidance. PURPOSE: To present a novel classification of bleb resulting from ab interno implantation of XEN-Gel-Stent and report association of tomographical patterns with IOP and SR. MATERIALS AND METHODS: A cross-sectional 1-armed study of patients receiving XEN-Gel-Stent. Tomographical changes in the bleb area were studied using swept-source optical coherence tomography in an early (d 29-90 postsurgery) and late (starting from d 91 postsurgery) phase. Frequency of patterns and their association with IOP and SR (defined as IOP<18 mmHg without medications) were studied. RESULTS: One hundred eleven examinations of 49 blebs (49 patients) were included. Three tomographical patterns at conjunctival, 4 at tenons capsule, and 2 at episcleral level were characterized. Most frequent conjunctival pattern was subconjunctival spaces (56.3% and 53.2% in the early and late phase, respectively) and associated with lower IOP (13.0±6.0 mmHg) and higher SR (89%) but only in the early phase compared with other conjunctival patterns ( P <0.05). At tenons capsule level, the hyporeflective pattern was most frequent (50% and 51.9% in early and late phase) followed by the cavernous pattern. Both patterns associated with lower IOP and higher SR compared with hyper-reflective or loss of tenon changes ( P <0.005). Most blebs showed no episcleral lake (87.5% and 89.9% in early and late phase). No difference of IOP and SR was noted compared with those showing an episcleral lake. CONCLUSION: A practical and clinically relevant novel classification system is proposed to tomographically describe and classify blebs after implantation of XEN-Gel-Stent. Certain patterns were associated with lower IOP and higher SR.

Comparing the efficacy of trabeculectomy and XEN gel microstent implantation for the treatment of primary open-angle glaucoma: a retrospective monocentric comparative cohort study.

The aim of this study was to compare the efficacy and safety profile of XEN microstent implantation with trabeculectomy (TET) in a comparable group of open-angle glaucoma cases in a retrospective, monocentric, single-surgeon setting. Each treatment group consisted of 100 eyes of 100 patients. At regular follow-up visits during the first 12 months after surgery, the following assessments were conducted and compared: intraocular pressure (IOP), number of IOP-lowering medications applied, best-corrected visual acuity (BCVA) and visual field testing. In both groups mean IOP was significantly reduced (p < 0.001). Mean IOP dropped from 24.8 ± 7.8 to 14.8 ± 4.0 mmHg in the TET and from 24.5 ± 6.7 to 16.6 ± 4.8 mmHg in the XEN group. The number of active compounds in the prescribed medication dropped from 3.3 ± 1.2 to 1.3 ± 1.4 in the TET and from 3.0 ± 1.1 to 1.4 ± 1.5 in the XEN group. BCVA and mean defect of static automated perimetry did not show a change of statistical significance in either group. Complications were more frequent after TET (p = 0.005) while postoperative needling was more frequent in the XEN group (p = 0.021). TET and XEN led to a significant reduction of IOP and IOP-lowering medication, while BCVA and visual field indices remained mostly unaltered over a 12-month postsurgical follow-up.