On the Current Care Situation and Treatment of Ocular Mucous Membrane Pemphigoid in Germany. / Zur Versorgungssituation und konservativen Therapie des okulären vernarbenden Schleimhautpemphigoids in Deutschland.

BACKGROUND: Ocular involvement in mucous membrane pemphigoid (MMP) is relatively rare, with a prevalence of 25 cases per million population, equating to approx. 2,100 patients throughout Germany. Diagnosis can be difficult - especially in cases of isolated ocular involvement - and treatment can be complex and lengthy. Immunosuppressants or immunomodulatory drugs are often used. Due to the complexity of diagnosis and treatment, MMP patients are usually referred to specialized centers. The aim of this project was to evaluate the current care situation of patients with ocular MMP in Germany. METHODS: A paper-based survey was designed and sent to all university eye clinics and other specialized centers in Germany in April 2020. The survey asked about the existence of a specialized outpatient service, the total annual number of patients with MMP, the annual number of newly diagnosed patients, any interdisciplinary collaboration for diagnostic or therapeutic purposes, as well as the local and systemic therapy used. RESULTS: Of a total of 44 clinics, 28 (64%) responded, reporting a total average of 27 ± 42 (0 - 200) patients and 3.6 ± 2.2 (0 - 10) new cases per year. This corresponds to a total of 741 patients. Only nine (32%) of the responding clinics offer specialized MMP clinics. 93% of the centers collaborate with the local dermatology department. 79% perform serological and histological diagnostics in-house. About half of the centers (n = 16) apply a standardized treatment regime. Systemic glucocorticoids (66.7%) are most commonly used, followed by mycophenolate mofetil and dapsone (57.1%), rituximab (33.3%), azathioprine and cyclophosphamide (28.6%), as well as methotrexate (19.0%). The least frequently used treatment is intravenous immunoglobulin (14.3%). CONCLUSION: This survey of German ophthalmology departments obtained data from about one third of the estimated total cohort of all patients with MMP in Germany. These are presumed to be exclusively patients with at least one ocular involvement. The complex care of these patients is usually provided in collaboration with a dermatologist and with the use of systemic anti-inflammatory medication. Currently, an ophthalmological MMP register is being established to better record the epidemiology and care situation of this rare disease in Germany and to improve it in the long term.

PreserFlo™ MicroShunt Versus Trabeculectomy in Patients With Moderate to Advanced Open-Angle Glaucoma: 12-Month Follow-Up of a Single-Center Prospective Study.

PURPOSE: The study compares the efficacy and safety of PreserFlo™ MicroShunt (Santen, Osaka, Japan) and trabeculectomy in eyes with moderate to advanced open-angle glaucoma. METHODS: In this prospective study, 300 patients (300 eyes) with moderate to advanced open-angle glaucoma were treated with either PreserFlo MicroShunt or trabeculectomy. The implantation of the PreserFlo MicroShunt was performed in 150 eyes (group A) and trabeculectomy was performed in 150 eyes (group B). The efficacy was evaluated by estimating the absolute and qualified success rates using the Kaplan-Meier survival analysis.  Results: During the 12-month follow-up period, 81.33% of eyes in group A and 94% in group B reduced intraocular pressure (IOP) >20% without glaucoma eye drops. The average IOP 12 months after surgery was 12.89±3.4 mmHg in group A and 11.39±4.5 mmHg in group B, which was significantly lower than the baseline intraocular pressure (group A: 23.47±8.36 mmHg, p=0.00053; group B: 22.03±5.2 mmHg, p= 0.0006). The number of topical medications administered 12 months after ocular surgery was 0.4±0.8 in group A and 0 in group B, compared to 2.5±1.2 in group A and 2.7±0.9 in group B at baseline (group A: p= 0.00091; group B: p= 0.00072). Ten eyes (6.67%) in group A and four eyes (2.67%) in group B were referred for bleb revision due to bleb fibrosis and consequent acute postoperative rise in IOP. Four eyes of group A and two eyes of group B were treated with transscleral cyclophotocoagulation. Five eyes in group B received re-trabeculectomy because of dysfunction of the primary bleb. CONCLUSION: PreserFlo MicroShunt reduced the number of antiglaucoma agents compared to baseline, but was inferior to trabeculectomy at reducing IOP after 12 months. Additionally, trabeculectomy produced better absolute success rates after 12 months than PreserFlo MicroShunt in the treatment of moderate to advanced open-angle glaucoma.

PreserFlo™ MicroShunt Combined with Phacoemulsification versus PreserFlo™ MicroShunt as a Standalone Procedure in Patients with Medically Resistant Open-Angle Glaucoma.

Purpose: To compare the efficacy and safety of PreserFlo™ MicroShunt (Santen, Osaka, Japan) combined with phacoemulsification to PreserFlo™ MicroShunt as a standalone procedure in eyes with moderate to advanced open-angle glaucoma. Methods: In an observatory, prospective, clinical study, 30 patients (30 eyes) with moderate to advanced angle glaucoma were allocated to either PreserFlo™ MicroShunt combined with phacoemulsification (15 eyes; Group A) or PreserFlo™ MicroShunt as a standalone procedure (15 eyes; Group B). The follow-up time of the study was 12 months. Results: Average intraocular pressure (IOP) at 12 months was 11.62 ± 1.6 mmHg in Group A and 13.8 ± 3.6 mmHg in Group B, which was significantly lower than baseline IOP (Group A: 23.47 ± 8.99 mmHg, P < 0.001; Group B: 23.4 ± 8.68 mmHg, P < 0.001). The absolute reduction of IOP within the 12 postoperative months was not significantly different between the two groups (P = 0.056). The number of the topical medications that were administered 12 months after ocular surgery was 0 in Group A and 0.6 ± 0.8 in Group B, compared to 3.13 ± 1.02 in Group A (P < 0.001) and 2.4 ± 1.45 in Group B (P = 0.004) at baseline. Phacoemulsification combined with PreserFlo™ MicroShunt significantly reduced the number of antiglaucoma agents after 12 months compared to the standalone procedure (P = 0.026). One eye in Group A was referred for bleb revision due to bleb fibrosis and a consequent acute postoperative rise in IOP. One eye in Group A required transscleral cyclophotocoagulation with MicroPulse® laser. One bleb revision was also necessary in Group B at the 4th postoperative week. Endothelial cell density did not significantly change over 12 months in either group (Group A: baseline, 2017.3 ± 346.8 cells/mm[2]; 12 months, 1968.5 ± 385.6 cells/mm[2]; P = 0.38; Group B: baseline, 2134.1 ± 382.6 cells/mm[2]; 12 months, 2094.4 ± 373.3 cells/mm[2], P = 0.42). The PreserFlo™ MicroShunt combined with phacoemulsification produced higher absolute success rates after 12 months in patients with moderate to advanced open-angle glaucoma than the PreserFlo™ MicroShunt as standalone procedure (Group A: 80% and Group B: 60%, P = 0.022). Conclusions: In eyes with moderate to advanced open-angle glaucoma, PreserFlo™ MicroShunt with or without phacoemulsification is effective in reducing IOP and the number of the antiglaucoma agents with a very small incidence of complications and subsequent glaucoma surgeries. However, adding phacoemulsification to PreserFlo™ MicroShunt successfully reduces IOP without the need for ongoing topical medications as are needed after the standalone procedure.

Preliminary results of Preserflo Microshunt versus Preserflo Microshunt and Ologen implantation.

PURPOSE: To report preliminary 6-month results on the use of the Preserflo Microshunt implant with and without Ologen in 50 pseudophakic eyes with moderate to advanced primary open-angle glaucoma (POAG). METHODS: Fifty pseudophakic eyes underwent ab externo Preserflo Microshunt implantation. Data was gathered retrospectively and two groups were then created, group A with application of MMC 0.2 mg/ml and group B with MMC 0.2 mg/ml and Ologen collagen matrix (OCM) implantation. Absolute success was regarded as the percentage of eyes achieving: a) 5 ≤ intraocular pressure (IOP) ≤ 13 mmHg, b) 5 ≤ IOP ≤ 16 mmHg, and c) 5 ≤ IOP ≤ 21 mmHg without additional medication or surgery and qualified success was regarded as the percentage of eyes achieving a) IOP ≤ 13 mmHg, b) IOP ≤ 16 mmHg, and c) IOP ≤ 21 mmHg with or without medication. Evaluation was performed using a log-rank Kaplan-Meier test. A scatterplot analysis presented the treatment effect data of all eyes with a minimum of 20% IOP reduction per case. Failure was defined as requiring additional surgery, IOP greater than 21 mmHg with or without medication and failure to reach 20% IOP reduction. RESULTS: Mean postoperative IOP was significantly lower in both groups. IOP decreased by 49.06% in group A and by 53.01% in group B at 6 months (P < 0.88), respectively. Medication use was lower in both groups (Wilcoxon test, P < 0.001). The absolute and qualified success rates were not statistically significant between the groups (all P > 0.05). Cumulative IOP results per case were not statistically different in group A compared with group B. One revision surgery in group A (4% failure rate) and three in group B (12% failure rate) were performed. CONCLUSIONS: Both groups showed equal results in terms of cumulative and mean IOP reduction, medication reduction as well as in absolute and qualified success rates. No significant difference was found in any parameters tested between Preserflo Microshunt with MMC 0.2 mg/ml and with or without OCM implantation at 6 months. Long-term follow-up is required to further evaluate this data.

Corneal transplant survival rate in glaucoma patients with multiple previous antiglaucoma surgeries.

BACKGROUND: Glaucoma can cause corneal decompensation and accelerate the failure of the graft. Previous antiglaucoma operations are one of the most important risk factors for endothelial failure. METHODS: In this retrospective study, 40 eyes of 40 glaucoma patients with advanced corneal decompensation after glaucoma surgery were treated with keratoplasty and outcomes were assessed for 24 months. RESULTS: 16, 9 and 15 eyes underwent Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) and penetrating keratoplasty (pKPL), respectively. Visual acuity improved at least 2 lines in 24 of 40 eyes after the three types of keratoplasty. All 40 eyes remained pain free for the follow-up period. The mean intraocular pressure (IOP) difference was not significantly different (p > 0.05) from the preoperative values 12 and 24 months after keratoplasty. The endothelial cell density of the donor cornea decreased from 2485.6 ± 165.18 to 1291.4 ± 467.1 and 1180.4 ± 397.2/mm2 (p < 0.001) after 12 and 24 months, respectively. Nine eyes (22.5%) had therapy-resistant corneal decompensation in the context of a transplant failure and were treated with a re-keratoplasty (2 re-pKPLs, 3 re-DSAEKs and 3 re-DMEKs). CONCLUSIONS: Eyes with previous glaucoma surgery show satisfying results after keratoplasty, mainly DMEK and pKPL.

The Efficacy of Ab Externo Canaloplasty by Using a Nonabsorbable Suture and No Viscoelastics; IOP Results, Intraoperative and Early Complication Rates within 6-Month Follow-Up Period.

BACKGROUND: To report the efficacy of ab externo canaloplasty by exclusively using only a nonabsorbable suture as a standalone operation or combined with phacoemulsification in terms of mean intraocular pressure (IOP), medication reduction, and intra- and postoperative complication rates as well as additional glaucoma surgery. PATIENTS AND METHODS: Forty-eight patients with primary open-angle glaucoma (POAG) and 50 eyes were divided into two groups according to the operation performed (Group A canaloplasty, n = 34 and Group B canaloplasty combined with phaco, n = 16), respectively. The success criteria were evaluated between three IOP ranges: a) IOP ≤ 16 mmHg, b) ≤ 18 mmHg, and c) ≤ 21 mmHg. Complete success was considered the percentage of eyes reaching these goals with no medication and qualified success with or without medication. Groups A and B were compared with the Kaplan-Meier test. Mean IOP and medication reduction as well as additional glaucoma surgery were also evaluated. The follow-up time was 6 months. Statistical importance was given at p < 0.05. RESULTS: Fail rate and intraoperative conversion of canaloplasty to other surgery (trabeculotomy due to extensive cheese-wiring) accounted for 12% (6 eyes), while a mandatory usage of the iTrack 250A microcatheter to successfully overcome intracanalicular bridging of the Schlemm's canal accounted for 20% (10 eyes). The most common early postoperative complications in both groups were hyphema, cheese wiring, and transient IOP rising. The mean IOP in Group A reduced from 23.67 ± 6.06 mmHg to 13.35 ± 4.23 mmHg and in Group B, it reduced from 23.55 ± 6.19 mmHg to 12.75 ± 1.5 mmHg at 6 months (p < 0.001). Group A's absolute success rates accounted for a) 44%, b) 47.1%, and c) 52.9% in comparison to Group B [a) 50%, b) 50%, and c) 56.3%] at 6 months (p < 0.05). Qualified success with or without medication showed no statistical differences between the groups. The mean medication reduction was significantly lower (p < 0.001) in both groups (Group A from baseline 3.2 ± 1.23 to 0.95 ± 1.35 and Group B from 3.12 ± 0.88 to 1.12 ± 0.75 at 6 months, respectively). Five eyes (10%) required additional glaucoma surgery. CONCLUSIONS: Ab externo canaloplasty by exclusively using only a nonabsorbable suture as a standalone operation or combined with phacoemulsification seems to lower the mean IOP and medication sufficiently. However, they pose a greater surgical challenge and intraoperative complication rate. Additional glaucoma surgery or medication following both procedures may be necessary to achieve an optimal target IOP.

Transscleral cyclophotocoagulation with MicroPulse® laser versus Ahmed valve implantation in patients with advanced primary open-angle glaucoma.

PURPOSE: To compare the efficacy of transscleral cyclophotocoagulation with MicroPulse® laser (Iridex, Silicon Valley, California, USA) with 3000 mW to Ahmed valve implantation in eyes with advanced stage of primary open-angle glaucoma. METHODS: In a prospective observational clinical study, 30 patients (30 eyes) with advanced open-angle glaucoma were randomized for either micropulse transscleral cyclophotocoagulation with 3000 mW or Ahmed valve implantation. Fifteen eyes were treated with transscleral cyclophotocoagulation with MicroPulse® laser with 3000 mW (group A) and 15 eyes with Ahmed valve implantation (group B). As inclusion criteria are included the diagnosis of advanced primary open-angle glaucoma, an intraocular pressure above 21 mmHg, cup-to-disk ratio 0.9-1.0, failure to meet the target IOP with either maximal tolerated local medical therapy (2-4 antiglaucoma agents) or systemic therapy (acetazolamide). The follow-up time of the study was 12 months. An absolute success was defined the achievement of IOP between 6 and 15 mmHg and at least 30% reduction of the IOP from baseline under reduced or the same number of antiglaucoma agents after the surgical procedure without following glaucoma surgeries and as qualified success the achievement of IOP between 6 and 18 mmHg and at least 20% reduction of the IOP from baseline regardless of the number of postoperative antiglaucoma agents. The efficacy was evaluated by estimating the absolute success rate and the qualified success rate using the Kaplan-Meier survival analysis. RESULTS: A reduction of the intraocular pressure > 30% was achieved in 33.3% of group A and in 73.3% of group B during the follow-up period of 12 months. A statistically significant decrease in the number of eye drops was observed in both groups (p < 0.01). 53.3% of the eyes of group A underwent additional anti-glaucoma procedures to achieve target intraocular pressure. The number of the local medications that were administered 12 months after the ocular surgery was 2 (± 1.3) in group A and 0.57 (± 0.9) in group B, compared to 3.2 (± 0.78) in group A and 3.33 (± 0.7) in group B administered prior to the surgery (p: 0.016). 8 eyes (53.33%) in group A were referred for additional treatment due to an acute postoperative rise in IOP (5 eyes: mTS-CPC, 1 eye: canaloplasty, 2 eyes: AGV implantation). No further anti-glaucoma procedures were necessary in group B. CONCLUSION: The Ahmed valve implantation achieves a more efficient decrease of the intraocular pressure as well as of the number of antiglaucoma agents than the transscleral cyclophotocoagulation with MicroPulse® diode laser 3000 mW. Additionally, the Ahmed valve implantation showed better results in terms of absolute and qualified success rates in the treatment of advanced primary open-angle glaucoma.

Comparison of performance between two microcatheter systems in ab externo canaloplasty: A retrospective comparison study.

PURPOSE: To compare the performance of two different microcatheter systems, iTrack™ 250A and Glaucolight, in ab externo canaloplasty in three major categories: intraocular pressure reduction, drug therapy reintroduction, and evaluation of viscodilation over distension of the inner wall of Schlemm's canal. METHODS: A total of 56 and 46 eyes from different glaucoma types underwent ab externo canaloplasty using two different microcatheter systems. Group formation was made according to microcatheter system used. Kaplan-Meier test was performed for drug therapy reintroduction in relation to the two microcatheters. Tests of between-subject effects in two-way analysis of variance evaluated the efficacy of the two microcatheters and their features in relation to intraocular pressure reduction. RESULTS: Kaplan-Meier test was not statistically significant (p = 0.20) regardless of microcatheter system. Tests of between-subject effects in relation to intraocular pressure reduction was not statistically different between the two microcatheters (p = 0.26) or between microcatheter and follow-up (p = 0.90). Intraocular pressure reduction in different glaucoma type was statistically significant during the follow-up period and glaucoma types showed different results between them in relation to follow-up (p < 0.001 and p = 0.002, respectively), but the pairwise comparison was not statistically important (p = 0.42). Intraocular pressure reduction was better in pseudophakic eyes in comparison with phakic eyes (p = 0.03), but the selection of microcatheter seemed not to affect this result (p = 0.11 and p = 0.32, respectively). CONCLUSION: Both microcatheter systems performed equal in terms of intraocular pressure reduction. Drug therapy reintroduction was not affected by the selection of the two microcatheters. Different types of glaucoma responded different to canaloplasty. Pseudophakic eyes responded better to treatment than phakic eyes, but the microcatheter selection seemed not affect this result.