To compare surgical success, postoperative intraocular pressure and complication rates between trabeculectomy and XEN gelstent surgery in a cohort of glaucoma patients in a typical clinical setting. A retrospective cohort study of consecutive patients with refractory open-angle glaucoma including patients who underwent either stand-alone XEN gelstent insertion with Mitomycin C or trabeculectomy with Mitomycin C between 2016 and 2018 at the University Eye Hospital Mainz, Germany. Primary outcome measure was the proportion of surgical success 1 year after surgery. Patients with an IOP ≤18mmHg, an intraocular pressure reduction of >20% and in no need of revision surgery or topical medication were considered a complete surgical success. If topical therapy was necessary, they were considered a qualified success. Multivariable logistic regression analysis was carried out for the primary outcome including gender, age, preoperative intraocular pressure and number of medication classes used preoperatively as adjustment variables. 171 eyes of 144 patients were included, including 82 eyes of 58 patients in the XEN group and 89 eyes of 86 patients in the trabeculectomy group. The primary outcome defined as the proportion of surgical success after 1 year (mean 11.1 months ± 2.2) was similar for both groups. The complete success proportion was 65.5% (95%-CI: 55.6–75.9%) in the trabeculectomy group, and 58.5% (95%-CI: 47.6–69.4%) in the XEN group and not statistically different in our analysis model (crude OR = 0.61; 95%-CI: 0.31–1.22; adjusted OR = 0.66; 95%-CI: 0.32–1.37). The intraocular pressure reduction, as secondary outcome measure, was higher in the trabeculectomy group (10.5 mmHg) compared to the XEN group (7.2 mmHg; p = 0.003) at the 12-month follow-up. Both XEN gelstent implantation and trabeculectomy show similar proportions of surgical success and of complications and are therefore both recommendable for clinical routine. However, trabeculectomy seems to be more effective in lowering intraocular pressure than the XEN implantation. A prospective randomized clinical trial is necessary to evaluate differences in the long-term clinical outcome.
Purpose: To assess surgical success and the post‐operative development of intraocular pressure between XEN45®gelstent, Preserflo®MicroShunt and trabeculectomy with mitomycin C.Methods: Data from 105 eyes from 105 patients of matched cases with refractory open‐angle glaucoma, who underwent surgery between January 2019, and August 2020, were evaluated. Patients underwent either stand‐alone XEN gelstent insertion with Mitomycin C, stand‐alone Preserflo with Mitomycin C or trabeculectomy with Mitomycin C. The primary outcome was the proportion of complete surgical success at 6 months post‐operatively (i.e. intraocular pressure between 5mmHg and 18mmHg, no revision surgery, no loss of light perception and no post‐operative pharmaceutical antiglaucomatous treatment). The reduction of intraocular pressure after 6 months, the classes of antiglaucomatous medication used post‐operatively, best‐corrected visual acuity, spherical refractive errors and astigmatism were assessed as secondary outcomes.Results: We included 35 eyes in each group. After 6‐month follow‐up, complete success was 73.5% [95%‐CI: 57.9%–89.2%] in the trabeculectomy group, 51.4% [95%‐CI: 34.0%–68.8%] in the XEN group and 74.2% [95%‐CI: 57.9%–90.5%] in the Preserflo group (p = 0.08). Regarding secondary outcomes, the reduction of intraocular pressure was 12.1 ± 7.9 mmHg in the trabeculectomy group and was thereby 5.8 [95%‐CI: 2.2–9.6] mmHg greater compared with the XEN group (p < 0.001) and 4.8 [95%‐CI: 0.9–8.7] mmHg higher than the Preserflo group (p = 0.01).Conclusions: No statistically significant differences were found between trabeculectomy, XEN45®gelstent implantation and Preserflo®MicroShunt implantation regarding surgical success after 6 months. Yet reduction in intraocular pressure was significantly higher in the trabeculectomy group. However, all three interventions resulted in sufficiently low post‐operative intraocular pressure and may therefore be considered individually for glaucoma treatment.
Objective To evaluate the long-term outcomes of trabeculectomy (TE) surgery in a large cohort with a minimum follow-up of 3 years. Design Retrospective cohort study. Setting University Eye Hospital, Germany. Participants Three hundred and seventy-nine patients with open-angle glaucoma underwent TE with mitomycin C (MMC) between January 2013 and February 2017 with a minimal follow-up of 3 years. Eligible patients were identified via an electronic surgical case register. Interventions All patients had undergone TE with MMC following a set surgical protocol. To assess the influence of cataract surgery following TE, eyes which underwent cataract surgery at least 6 months after TE were matched 1:3 by sex and age to eyes who did not undergo cataract surgery during the follow-up period. Main outcome measures Primary outcome was the proportion of surgical success based on intraocular pressure (IOP), surgical complications, the need for revision surgery, loss of light perception and the need for additional pressure-lowering medication. Results The mean follow-up time was 6 (±0.8, IQR: 5.4–6.5) years. Seventy-three per cent of eyes achieved qualified surgical success at the last follow-up (IOP≥5 mm Hg and ≤18 mm Hg, without surgical complications or complete loss of vision) but necessitated additional medical therapy, complete surgical success with no additional medical therapy was achieved in 69% of eyes. There was no significant difference in the success probability between eyes that had undergone cataract surgery after TE and those that had not (p=0.45). Conclusions The results demonstrate a high and stable success rate of TE after a mean follow-up time of approximately 6 years, that is, not affected by later cataract surgery.
Childhood glaucoma is a heterogeneous disease and can be associated with various genetic alterations. The aim of this study was to report first results of the phenotype–genotype relationship in a German childhood glaucoma cohort. Forty-nine eyes of 29 children diagnosed with childhood glaucoma were prospectively included in the registry. Besides medical history, non-genetic risk factor anamnesis and examination results, genetic examination report was obtained (23 cases). DNA from peripheral blood or buccal swab was used for molecular genetic analysis using a specific glaucoma gene panel. Primary endpoint was the distribution of causative genetic mutations and associated disorders. Median age was 1.8 (IQR 0.6; 3.8) years, 64% participants were female. Secondary childhood glaucoma (55%) was more common than primary childhood glaucoma (41%). In 14%, parental consanguinity was indicated. A mutation was found in all these cases, which makes consanguinity an important risk factor for genetic causes in childhood glaucoma. CYP1B1 (30%) and TEK (10%) mutations were found in primary childhood glaucoma patients. In secondary childhood glaucoma cases, alterations in CYP1B1 (25%), SOX11 (13%), FOXC1 (13%), GJA8 (13%) and LTBP2 (13%) were detected. Congenital cataract was associated with variants in FYCO1 and CRYBB3 (25% each), and one case of primary megalocornea with a CHRDL1 aberration. Novel variants of causative genetic mutations were found. Distribution of childhood glaucoma types and causative genes was comparable to previous investigated cohorts. This is the first prospective study using standardized forms to determine phenotypes and non-genetic factors in childhood glaucoma with the aim to evaluate their association with genotypes in childhood glaucoma.
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.
To quantify the results of childhood glaucoma treatment over time in a cohort of children with different types of childhood glaucoma. A retrospective cohort study of consecutive cases involving children with primary congenital glaucoma, primary juvenile, and secondary juvenile glaucoma at the Childhood Glaucoma Center, University Medical Center Mainz, Germany from 1995 to 2015 was conducted. The main outcome measure was the long-term development of intraocular pressure. Further parameters such as surgical success, refraction, corneal diameter, axial length, and surgical procedure in children with different types of childhood glaucoma were evaluated. Surgical success was defined as IOP < 21 mmHg in eyes without a need for further intervention for pressure reduction. A total of 93 glaucomatous eyes of 61 childhood glaucoma patients with a mean age of 3.7 ± 5.1 years were included. The overall mean intraocular pressure at first visit was 32.8 ± 10.2 mmHg and decreased to 15.5 ± 7.3 mmHg at the last visit. In the median follow-up time of 78.2 months, 271 surgical interventions were performed (130 of these were cyclophotocoagulations). Many (61.9%) of the eyes that underwent surgery achieved complete surgical success without additional medication. Qualified surgical success (with or without additional medication) was reached by 84.5% of the eyes.