BACKGROUND: Preserflo MicroShunt is a novel microinvasive bleb forming device for the treatment of primary open-angle glaucoma. The intermediate- and long-term success and the impact of this procedure on corneal endothelial cell density remain to be investigated.
METHODS: In this prospective observational study, 62 eyes of 55 glaucoma patients (mean age ± SD: 67.0 ± 15.0 years) receiving a Preserflo MicroShunt were included. Corneal endothelial cell density, intraocular pressure and best corrected visual acuity were assessed preoperatively and at 3, 6, 9, 12, 18 and 24 months postoperatively. Success rates, bleb revision rates and complications were analysed. Complete success was defined as an intraocular pressure reduction of ≥ 20% and achieving a target pressure of ≤ 18, ≤ 15 or ≤ 12 mmHg without antiglaucoma medication. Qualified success indicated that the criteria were reached with or without medication.
RESULTS: Corneal endothelial cells showed no significant decline over 24 months (p > 0.05). Intraocular pressure showed a substantial reduction postoperatively (p < 0.001), decreasing from 29.6 ± 8,3 mmHg to 13.0 ± 4.3 mmHg after 24 months (p < 0.001). Complete and qualified success with a target pressure ≤ 15 mmHg was achieved in 52.9% and 54.6% of cases after 24 months, respectively. Best corrected visual acuity did not change after 24 months.
CONCLUSIONS: Preserflo MicroShunt had no negative side effects on corneal endothelial cells and showed favourable success rates after 2 years in patients with open-angle glaucoma.

OBJECTIVE: To evaluate the efficacy and safety of combined cataract surgery with insertion of an ab interno trabecular microbypass device (iStent Inject, Glaukos Corporation) compared to cataract surgery alone in patients with mild-to-moderate glaucoma.
METHODS: Prospective, randomized, assessor-masked controlled trial at a single centre.
METHODS: Eyes with visually-significant cataract and mild-to-moderate glaucoma with preoperative intraocular pressure (IOP) of 12 to 30 mmHg on 0 to 3 ocular hypotensive medications.
METHODS: Participants eyes were randomized (2017-2020) 1:1 to combined cataract surgery with iStent Inject (treatment group, n = 56) or cataract surgery alone (control group, n = 48), and followed up for 2 years.
METHODS: The co-primary effectiveness endpoints were the number of ocular hypotensive medications and IOP at 24-months post-surgery. The secondary effectiveness endpoints were ocular comfort as measured by the Ocular Surface Disease Index (OSDI) and vision-related quality of life as measured by the Glaucoma Activity Limitation Questionnaire (GAL-9) at 24-months. Safety measures included postoperative visual acuity, any unplanned return to the operating theatre, adverse events, and complications.
RESULTS: Participants (67.3% male) were aged 53 to 85 years, and treatment groups were similar in terms of mean medicated IOP (treatment group 17.7 mmHg ± 4.0; control group 17.1 mmHg ± 3.1), and number of ocular hypotensive medications (treatment group 1.69 ± 1.05; control group 1.80 ± 1.22) at baseline. At 24 months, the number of ocular hypotensive medications were 0.7 ± 0.9 in the treatment groups compared to 1.5 ± 1.9 in the control group, with an adjusted difference of 0.6 fewer medications per eye in the treatment group (95% CI 0.2-1.1, P = 0.008). In the treatment group, 57% of eyes were on no glaucoma medications compared to 36% in the control group. There was no significant difference in IOP between the 2 groups beyond the 4-weeks. There were no differences in patient-reported outcomes between the 2 groups. The visual outcomes and safety profiles were similar between the 2 groups.
CONCLUSIONS: Combined cataract surgery with iStent Inject achieved a clinically- and statistically-significantly greater reduction in ocular hypotensive medication usage at 24-months compared to cataract surgery alone, with no significant difference in IOP.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

BACKGROUND: The most common retinal complications after glaucoma surgery are choroidal detachment, hypotony maculopathy, malignant glaucoma, vitreous hemorrhage, endophthalmitis and retinal detachment. However, if glaucoma surgery is a risk factor for the ERM development needs to be clarified. This study aims to assess the incidence of epiretinal membrane (ERM) in 2 years of follow-up in patients with primary open-angle glaucoma (POAG) treated with Ex-Press shunt implant.
METHODS: A prospective, consecutive, single-center, case-control study. We enrolled patients affected by POAG and scheduled for Ex-Press device implant with or without concomitant cataract surgery. The control group was the contralateral eyes which continues anti-glaucomatous eyedrops. Complete ophthalmologic evaluation and spectral-domain optical coherence tomography were performed before surgery, at 6 months and 24 months of follow-up.
RESULTS: Eighty-two eyes of 41 consecutive patients, 18 males and 23 females with a mean age of 70, 29 ± 8,45, were analyzed at 24 months. 39.1% of eyes developed ERM: 29.3% were cellophane macular reflex (CMR) and 9.8% were pre-macular fibrosis (PMF). In the control group, 19.5% of eyes developed ERM: 17.1% were CMR and 2.4% were PMF. No statistically significant difference was reported (p = 0.121) between treated and control group. ERM development did not affect significantly the central foveal thickness (260.13 ± 35.01 μm at baseline, 265.03 ± 34.90 μm at 6 months and 275.18 ± 33.31 μm at 24 months) and macular volume (7.75 ± 0.43 mm3 at baseline, 7.77 ± 0.48 mm3 at 6 months and 7.77 ± 0.46 mm3 at 24 months), remained comparable to reported average measures in healthy individuals during the follow-up. Concomitant cataract surgery did not increase the ERM incidence.
CONCLUSIONS: Ex-Press implant may increase the ERM incidence regardless concomitant cataract surgery, accelerating or inducing a posterior vitreous detachment, such as other ocular surgical procedure. Nevertheless, the vast majority of ERM are CMR, not affecting the macular profile.

OBJECTIVE: Recommendations on general glaucoma management and the use of early minimally invasive and microincisional surgeries are limited. This study aimed to establish consensus regarding glaucoma management, focusing on the XEN-45 gel stent implant.
METHODS: A Delphi consensus-driven process was used. The scientific committee led the study, identified the expert panel, and participated in elaborating the questionnaire. Fifty-one panelists were invited to complete, on a nine-point Likert scale, an 89-item questionnaire covering three topic blocks. Two Delphi rounds were performed. Consensus was achieved if ≥66.6% of panelists reached agreement or disagreement.
RESULTS: Panelists agreed on 84 items related to the patients\' quality of life, the therapeutic algorithm and patient profile, and surgical and pre- and post-operative management. Panelists agreed on the suitability of XEN stent implants to treat glaucoma at different stages and for different patient profiles: young patients, elderly or with significant comorbidities, and with myopic glaucoma, patients who failed previous surgeries, and with previous poor post-operative experience. XEN surgery was considered a therapeutic step prior to classic filtering surgery and a possible first surgical option in elderly patients with comorbidities and uncontrolled intraocular pressure. XEN surgery allows the patient to return to routine daily activities faster than conventional filtering surgeries and to reduce and/or eliminate topical treatments.
CONCLUSIONS: This Delphi-driven consensus resulted in a series of general recommendations for glaucoma management, including those related to patient quality of life, therapeutic algorithm, and patient profile, and specific ones regarding the use of XEN stent gel surgery.

The aim of this study was to compare the effectiveness of trabeculectomy (TE) and deep sclerectomy (DS) in lowering intraocular pressure (IOP) and thereby preserving visual field and peripapillary retinal nerve fiber layer (RNFL) tissue in primary open-angle glaucoma (POAG) cases. IOP, number of IOP-lowering medications, visual acuity, mean defect of standard automated perimetry, and mean peripapillary RNFL thickness were retrospectively collected and followed up for 3 years after surgery. TE was performed in 104 eyes and DS in 183 eyes. Age, gender, laterality, IOP, number of medications, visual acuity, perimetry mean defect, and peripapillary RNFL thickness were equally distributed at baseline. Mean IOP decreased from 23.8 ± 1.4 mmHg and 23.1 ± 0.4 mmHg to 13.4 ± 0.6 mmHg (p < 0.001) and 15.4 ± 0.7 mmHg (p = 0.001) in the TE and DS groups, respectively. Mean defect remained stable (TE: -11.5 ± 0.9 dB to -12.0 ± 1.1 (p = 0.090); DS: -10.5 ± 0.9 dB to -11.0 ± 1.0 dB (p = 0.302)), while mean peripapillary RNFL thickness showed further deterioration during follow-up (TE group: 64.4 ± 2.1 μm to 59.7 ± 3.5 μm (p < 0.001); DS group: 64.9 ± 1.9 μm to 58.4 ± 2.1 μm (p < 0.001)). Both TE and DS were comparably effective concerning postoperative reduction in IOP and medication. However, glaucoma disease further progressed during follow-up.

BACKGROUND: To compare the intermediate-term efficacy of PRESERFLO (PF) MicroShunt implantation with trabeculectomy (TE) in patients with primary open-angle glaucoma, focusing on longitudinal changes of functional and structural parameters.
METHODS: This retrospective comparative study included 104 eyes of 104 patients who underwent TE and 83 eyes of 83 patients that underwent PF implantation between January 2019 and December 2020, with a minimum follow-up of two years. Baseline and postoperative intraocular pressure (IOP), number of IOP-lowering medications, visual field mean defect (MD) and peripapillary retinal nerve fibre layer (RNFL) thickness measured using optical coherence tomography were assessed and compared between groups.
RESULTS: Baseline characteristics (age, sex, IOP, number of IOP-lowering medications, MD, RNFL thickness) were comparable between the two groups (all P > 0.05). During the two-year of follow-up, mean IOP decreased from 24.09 ± 1.15 mmHg and 21.67 ± 0.77 mmHg to 11.37 ± 1.13 mmHg (P < 0.001) and 15.50 ± 1.54 mmHg (P = 0.028), and the mean number of IOP-lowering medications decreased from 3.25 ± 0.14 and 3.51 ± 0.14 to 0.53 ± 0.14 (P < 0.001) and 1.06 ± 0.43 (P < 0.001) in the TE and PF groups, respectively. MD remained stable [- 11.54 ± 0.93 dB and - 11.17 ± 1.66 to - 10.67 ± 0.91 dB (P = 0.226) and - 10.40 ± 4.75 dB (P = 0.628) in the TE and PF groups, respectively] but RNFL thickness decreased continuously during follow-up [62.79 ± 1.94 µm and 62.62 ± 2.05 µm to 57.41 ± 1.81 µm (P < 0.001) and 60.22 ± 1.98 µm (P = 0.182) in the TE and PF groups, respectively].
CONCLUSIONS: PF implantation is comparably effective in the intermediate term in lowering IOP and reducing the use of IOP-lowering medications over a two-year follow-up period. Although visual field defects were stable, RNFL continued to decrease during postoperative follow-up.

OBJECTIVE: To analyze the results of the Xen45 implant in our hospital center, both in terms of efficacy and safety.
METHODS: Observational, retrospective, single-center study of patients undergoing Xen45 surgery at the University Hospital of Jaén between January 1, 2018 and June 31, 2021.
RESULTS: A total of 73 patients were implanted with the Xen45 device (48 with in combined surgery with phacoemulsification of the crystalline lens and 25 standalone Xen45 surgery). IOP decreased from 19.9 ± 4.9 mmHg at the first visit to a mean of 17.1 ± 5.3 (P = .001) at the sixth month. Drug use required between the first visit and Xen implantation was reduced from 2.1 ± 0.9 to 0.6 (P < .000). A second surgery was necessary in 18 patients (26.6%) in the first 6 months.
CONCLUSIONS: Glaucoma surgery by Xen45 implant, alone or combined with cataract surgery, is an effective and safe procedure for IOP lowering.

UNASSIGNED: To compare the outcomes of non-penetrating deep sclerectomy (NPDS) for primary congenital glaucoma (PCG) performed by experienced vs trainee surgeons.
UNASSIGNED: This retrospective cohort study was conducted in 2022 in Saudi Arabia. Consultants (Gr-1) and trainee pediatric ophthalmologists (Gr-2) performed NPDS on pediatric patients with PCG. Success was defined as an intraocular pressure (IOP) less than 21 mmHg at 6 months after surgery. Complications, glaucoma medications, and additional procedures were also observed in the two groups.
UNASSIGNED: Gr-1 and Gr-2 operated on 14 and 39 eyes with PCG, respectively. The absolute success rates were 90.9% (95% confidence interval [CI]: 73.9, 100) in Gr-1 and 96.7% (95% CI: 90.2, 100) in Gr-2 (odds Ratio=1.1; 95% CI: 0.87, 1.3; P=0.54). Survival analysis suggested that the failure rate in the first 6 months after NPDS was not significantly different between the two groups (hazard ratio=1.45; 95% CI: 0.13, 16.0; P=0.767). The complications included hypotony (2 cases), vitreous hemorrhage (1 case), and total flap penetration (1 case). Only one eye in Gr-2 needed glaucoma medication after surgery. There was no significant difference in the success rates of one surgeon before and after training (P=0.43). The age (P=0.59) and sex (P=0.77) of patients, type of surgeon (P=0.94), and preoperative IOP (P=0.59) were not significant predictors of a stable IOP at 6 months after NPDS.
UNASSIGNED: At 6 months after NPDS surgery performed by experienced and trainee pediatric ophthalmologists, the outcomes (stabilization of IOP) were similar between the two groups.

BACKGROUND: The aim of this study was to compare trabeculectomy outcomes in patients with and without post-operative serous choroidal detachment (CD) and establish an association between CD and trabeculectomy outcomes.
METHODS: In this 4-year retrospective cohort study, medical records of glaucoma patients older than 18 who underwent primary trabeculectomy with Mitomycin-C between 2012 and 2020 were reviewed. Phakic eyes without history of any other intraocular surgery and with at least one year of follow-up were included in the study. Postoperative CD was defined as clinically visible CD developed within the first postoperative week. Cases were categorized into with and without CD and trabeculectomy outcomes were compared. Comparison was carried out using postoperative intraocular pressure (IOP), glaucoma medications and surgery success. Two levels of success were defined regardless of glaucoma medications; criteria A) 5 < IOP < 19 mmHg and criteria B) 5 < IOP < 16 mmHg. In addition to the defined IOP ranges, IOP reduction less than 20% from baseline and further glaucoma surgery were also counted as surgery failures.
RESULTS: Total of 183 patients including 153 without CD (mean age 58.73 ± 11.40 years, mean IOP 23.7 ± 6.63 mmHg) and 30 with CD (59.00 ± 12.59 years, mean IOP 22.2 ± 3.83 mmHg) entered the study. Post-trabeculectomy mean IOPs were significantly higher in the CD group at all follow-up visits at year 1 through 4 (14.70, and 14.82 mmHg vs. 11.03, and 12.59 mmHg; p-value < 0.05). Similarly mean number of glaucoma medications was higher in the CD group at all follow-up visits (p-value > 0.001). Based on success criteria A, cumulative probability of success for patients with CD wasn\'t significantly different compared to those without CD at years 1 through 4 (80.0%, and 69.6% vs. 88.2%, and 74.1% respectively; p-value > 0.05, log-rank). However, based on success criteria B, patients with CD had significantly lower cumulative probability of success at years 1 through 4 (50.0% and 8.9% vs. 79.7% and 59.8%, p-value < 0.001).
CONCLUSIONS: We established that early post-trabeculectomy serous choroidal detachment is associated with adverse surgery outcomes. Lower rate of surgery success and higher mean postoperative IOP and glaucoma medications were observed in patients with post-trabeculectomy choroidal detachment and this was more pronounced in patients who required more stringent IOP control (success definition 5 < IOP < 16 mmHg).

Transient hypotony is the most common early complication after Preserflo MicroShunt (PMS) implantation. High myopia is a risk factor for the development of postoperative hypotony-related complications; therefore, it is advisable that PMS implantation in patients should be performed while employing hypotony preventive measures. The aim of this study is to compare the frequency of postoperative hypotony and hypotony-related complications in high-risk myopic patients after PMS implantation with and without intraluminal 10.0 nylon suture stenting. This is a retrospective, case-control, comparative study of 42 eyes with primary open-angle glaucoma (POAG) and severe myopia that underwent PMS implantation. A total of 21 eyes underwent a non-stented PMS implantation (nsPMS), while in the remaining eyes (21 eyes), PMS was implanted with an intraluminal suture (isPMS group). Hypotony occurred in six (28.57%) eyes in the nsPMS group and none in the isPMS group. Choroidal detachment occurred in three eyes in the nsPMS group; two of them were associated with the shallow anterior chamber and one was associated with macular folds. At 6 months after surgery, the mean IOP was 12.1 ± 3.16 mmHg and 13.43 ± 5.22 mmHg (p = 0.41) in the nsPMS and isPMS group, respectively. PMS intraluminal stenting is an effective measure to prevent early postoperative hypotony in POAG highly myopic patients.