Inter-eye relationship of intraocular pressure change after unilateral trabeculectomy, filtering canaloplasty, or PreserFlo™ microshunt implantation

Aghayeva, Fidan; Chronopoulos, Panagiotis; Schuster, Alexander K.; Pfeiffer, Norbert

doi:10.1007/s00417-021-05188-y

Cited by 9 publications

(16 citation statements)

References 25 publications

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“…There is no clear consensus in the peer-reviewed literature on the most efficacious dose and time of MMC to be used during this surgery. 22 In our study, 0.2 mg/mL MMC was used for 2 minutes as it has been done in previous studies, [10][11][12][13]16,20 because the scientific evidence to strongly recommend the use of higher concentrations of MMC in populations of European descent is still scarce. Previously reported data from a multicenter study conducted across multiple European sites by multiple surgeons using 2 different concentrations of MMC (0.2 and 0.4 mg/mL) 14 FIGURE 2.…”

Section: Discussionmentioning

confidence: 99%

“…4 The studies that have analyzed this device have shown different sample sizes (from 14 to 156 eyes) and follow-up times (1 wk-5 y). [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] In a recent major review, Bell et al 22 pointed out that the best available evidence regarding mitomycin C (MMC) dosing in combination with this device had been reported in the study carried out by Riss et al, 5 that compared 87 eyes with 2 concentrations of MMC (0.2 and 0.4 mg/mL) and locations (near and away from the limbus). The authors concluded that the trend was to increase the efficacy with higher concentrations of MMC placed close to the limbus.…”

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confidence: 99%

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Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma

Barberá¹,

Galdón²,

Magro³

et al. 2022

Journal of Glaucoma

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Précis: The Preserflo Microshunt (PSM) is a safe and effective glaucoma microfiltering implant that significantly reduces the intraocular pressure (IOP), either alone or in combination with phacoemulsification, during the first year after surgery. Purpose:The purpose of this study was to assess the safety and efficacy of the PSM for the treatment of open angle glaucoma with 0.2 mg/mL mitomycin C, either alone or in combination with cataract surgery. Methods:A retrospective, open-label study of 64 eyes with primary open angle glaucoma that underwent PSM implantation and were followed up for at least 9 months. Success was defined as IOP 6-17 mm Hg and a reduction of at least 20%, complete without hypotensive medication, and qualified with medication. Safety was assessed by the incidence of adverse events. Secondary endpoints included mean hypotensive medications, visual acuity, and incidence of needling and surgical revision.Results: A total of 51 eyes underwent PSM alone and 13 underwent PSM+phacoemulsification. In the overall population of the study, the mean IOP was significantly reduced from 22.03 ± 0.7 mm Hg at baseline to 12.7 ± 0.4 mm Hg at the final visit, P < 0.0001 (mean follow-up: 11 ± 1.4 mo). The IOP was significantly reduced in both groups (P < 0.0001). Ocular hypotensive medication was reduced significantly from 2.7 ± 0.7 to 0.2 ± 0.5 (P < 0.0001). No significant differences were found in IOP-lowering medication between groups (PSM alone, 0.2 ± 0.08; PSM+phacoemulsification, 0.1 ± 0.1; P = 0.2). At the final visit, 70.3% were considered as complete success and 12.5% as qualified success. The most common adverse event was clinical hypotony (7.8%) followed by hyphema (4.7%), and anterior chamber reformation (1.6%). Overall, 1.6% required needling and 15.6% surgical revision to restore the flow. Conclusion:Glaucoma surgery with the PSM and mitomycin C was efficacious and safe in the short term, either alone or in combination with cataract surgery, and may be considered a surgical option for lowering IOP in primary open angle glaucoma.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma

Barberá¹,

Galdón²,

Magro³

et al. 2022

Journal of Glaucoma

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“…Clinical studies have previously reported previously that monocular treatments can affect fellow eyes,30–32 meaning that comparison of measures between treated and fellow eyes cannot serve as valid controls, and that population norms are the most useful comparators. Given that both the treated and fellow eyes showed a slower progression rate compared with previous reports, there may also be a similar sympathetic response in the fellow untreated eye.…”

Section: Discussionmentioning

confidence: 99%

Phase 1B study of the safety and tolerability of the mineralocorticoid fludrocortisone acetate in patients with geographical atrophy

Hong¹,

Chang

Maddess

et al. 2022

BMJ Open Ophth

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ObjectiveTo evaluate the safety and tolerability of a mineralocorticoid, in a single-dose intravitreal (IVT) injection of 1 mg/0.1 mL and 2 mg/0.1 mL fludrocortisone acetate (FCA) in subjects with geographical atrophy (GA) secondary to age-related macular degeneration.Methods and AnalysisThis phase 1b study was a two-part dose-escalation prospective study. Part 1 involved a single participant treated with 1 mg/0.1 mL and monitored up to 28 days before being reviewed by a safety review committee. Two subsequent participants were then dosed with the same dose. Part 2 involved a single participant dosed with 2 mg/0.1 mL and monitored up to 28 days when a further five participants were dosed. All participants were followed up for 6 months after baseline.A full ophthalmic assessment was performed at study visits which included GA area, best-corrected visual acuity (BCVA), low-luminance BCVA (LL-BCVA) and intraocular pressure (IOP). Adverse events (AEs) were reported from the first dose of FCA until the end-of-study visit.ResultsThere were no serious AEs (ocular or systemic) observed with IVT FCA at either 1 mg/0.1 mL or 2 mg/0.1 mL among nine participants. There was no evidence of increased IOP or cataract development.Neither BCVA or LL-BCVA changed significantly in the study-eye over the follow-up period (p=0.28 and 0.38, respectively). Mean GA area increased in the study (0.5 mm2, p=0.003) and fellow-eyes (0.62 mm2, p=0.02) over 6 months. Differences between eyes were not significant (p=0.64), and at the lower end of population norms.ConclusionIVT FCA is clinically safe and well tolerated and did not increase IOP.

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“…Most fellow eyes in the 2 other groups did not show significant IOP change, however, IOP elevation occurred in 12.7% of all fellow eyes and it happened mostly on POD1, necessitating starting antiglaucoma medication in 2 eyes. 24 There is a complex intereye IOP relationship in different surgical procedures and the same is true upon using antiglaucoma medications, as 1 cannot expect the same IOP lowering effect by using an antiglaucoma agent in both eyes of 1 patient. 25 The mechanism for the COR is not well understood.…”

Section: Discussionmentioning

confidence: 99%

Intraocular Pressure Changes in the Contralateral Eye After Glaucoma Surgery

Meshksar

Hajizadeh

Sharifipour

et al. 2021

Journal of Glaucoma

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Précis: Glaucoma surgery in 1 eye can result in significant intraocular pressure (IOP) elevation in the fellow eye in a significant percentage of subjects. This effect is more pronounced following glaucoma drainage device implantation and in subjects developing postoperative hypotony in the first eye.Purpose: The aim was to investigate the course and magnitude of IOP changes in contralateral eyes following glaucoma surgery.Patients and Methods: We studied 131 glaucoma patients undergoing surgery. IOP changes in fellow eyes and the number of glaucoma medications were recorded for 6 months. Both normal and glaucomatous fellow eyes were included. Patients on preoperative acetazolamide were analyzed separately. IOP change ≥ 4 mm Hg or 20% increase from baseline values was considered significant.Results: Baseline IOP in fellow eyes was 13.1 ± 3.3 mm Hg which increased significantly at all-time points with a peak at 1 week (mean increase: 3.1 ± 3.2 mm Hg) gradually decreasing up to 6 months (mean increase 0.9 ± 2.1 mm Hg). The number of fellow eyes with clinically significant IOP elevation at 1

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Inter-eye relationship of intraocular pressure change after unilateral trabeculectomy, filtering canaloplasty, or PreserFlo™ microshunt implantation

Cited by 9 publications

References 25 publications

Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma

Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma

Phase 1B study of the safety and tolerability of the mineralocorticoid fludrocortisone acetate in patients with geographical atrophy

Intraocular Pressure Changes in the Contralateral Eye After Glaucoma Surgery

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