scholarly journals Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial

2021 ◽  
pp. bjophthalmol-2021-320023
Author(s):  
Peter Szurman ◽  
Kaweh Mansouri ◽  
H. Burkhard Dick ◽  
Andre Mermoud ◽  
Esther M Hoffmann ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Glaucoma Surgery ◽  
Applanation Tonometry ◽  
Deep Sclerectomy ◽  
Open Label ◽  
Registration Number ◽  
And Performance ◽  
Telemetric Measurement

AimTo investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).MethodsProspective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor’s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT).ResultsThe eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA –4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30–2.29) was reached on day 10 and continuously improved to an agreement of –0.15 mm Hg ±2.28 (LoA –1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months).ConclusionsAfter 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.Trial registration numberNCT03756662.

The effectiveness of descemethogoniopuncture depending on the timing of its implementation after microinvasive non-penetrating deep sclerectomy in patients with glaucoma

2021 ◽  
pp. 79-82
Author(s):  
E.L. Sorokin ◽  
◽  
N.V. Postupaeva ◽  
◽  
Keyword(s):  
Intraocular Pressure ◽  
Antihypertensive Effect ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Hypotensive Effect ◽  
Ultrasound Biomicroscopy ◽  
Deep Sclerectomy ◽  
Group 2 ◽  
Group 1

Purpose. Evaluation of the efficacy of descemethogoniopuncture (DGP) at various times after microinvasive non-penetrating deep sclerectomy (MNPDS) in patients with glaucoma. Material and methods. The analysis of the results of DGP in 64 eyes of patients with primary open-angle glaucoma after previously performed MNPDS. According to the timing of DGP after MNPDS, the patients were divided into 3 groups. In the 1st group BPH was performed after 1–2 months (22 eyes), the 2nd group – after 3–4 months (21 eyes), the 3rd group after 5–6 months (21 eyes). The follow-up period was 1 year. Results. The level of intraocular pressure before DGP averaged 15.1±0.6 mm Hg in group 1, 17.5±0.9 mm Hg in group 2, and group – 18.6±0.7 mm Hg. After DGP, 13.1±0.4 mm Hg, 14.6±0.7 mm Hg, 16.1±0.5 mm Hg respectively. According to ultrasound biomicroscopy, the highest and extended intrascleral cavities and tunnels, as well as a thin loose trabeculodescemet membrane (TDM), were observed in the eyes of the 1st group. With an increase in the time after MNPDS, there was a compaction of TDM, a decrease in the height and length of the intrascleral cavity and tunnels. 12 months after DGP, the most pronounced antihypertensive effect without antihypertensive therapy occurred in group 1 – 55% of cases compared with groups 2 and 3 (33% and 14% respectively). Conclusion. The greatest efficiency was shown by performing DGP within 1–2 months after MNPDS, which is associated with the minimum development of proliferative processes in the intrascleral outflow tract in the early stages after this operation. Key words: descemethogoniopuncture, microinvasive non-penetrating deep sclerectomy, intraocular pressure, hypotensive effect, glaucoma.

Deep Sclerectomy with Mitomycin C for Glaucoma Secondary to Uveitis

2011 ◽  
Vol 21 (6) ◽  
pp. 708-714 ◽  
Author(s):  
Nitin Anand
Keyword(s):  
Intraocular Pressure ◽  
Mitomycin C ◽  
Case Series ◽  
Glaucoma Surgery ◽  
Cumulative Probability ◽  
Deep Sclerectomy ◽  
Retrospective Case ◽  
Uveitic Glaucoma ◽  
Needle Revision

Purpose. To report outcomes of deep sclerectomy augmented with mitomycin C (MMC) in eyes with raised intraocular pressure (IOP) secondary to uveitis. Methods. This was a retrospective case series of 26 eyes of 26 patients with uveitic glaucoma. Mitomycin C 0.2–0.4 mg/mL was applied subconjunctivally prior to scleral flap dissection for 2–3 minutes. Results. Mean follow-up was 46.5±22 months (range 12–83). Fifteen eyes (58%) had previous intraocular surgery. Preoperative IOP was 33±12 mmHg. Intraocular pressure at 1, 2, and 3 years after surgery was 13±4 mmHg, 13±4 mmHg, and 14±4 mmHg, respectively. The probability of IOP <21 and 18 mmHg with needle revision and laser goniopuncture but without medications or further glaucoma procedure was 89% and 84%, respectively, at 3 years. The cumulative probability for performing laser goniopuncture was 42% at 1 year, 50% at 2 years, and 64% at 3 years. Needle revision was performed in 6 eyes (23%). Three (12%) patients required further glaucoma surgery. The number of glaucoma medications decreased from 3.3±1.2 to 0.3±0.8 by last follow-up (p<0.001). Four eyes (15%) were on medications to control IOP Intraoperative perforation of trabeculo-Descemetic membrane occurred in 3 eyes (12%) and late iris entrapment in perforation or goniopuncture in 4 eyes (15%). Recurrence of uveitis was seen in 11 eyes (42%) with no loss in IOP control. Conclusions. Deep sclerectomy with MMC appears to be a safe and effective procedure to lower IOP in uveitic glaucoma with a low rate of complications.

Penetrating deep sclerectomy in primary open-angle and pseudoexfoliative glaucoma

2019 ◽  
Vol 30 (2) ◽  
pp. 264-268
Author(s):  
Vassilios Kozobolis ◽  
Eleni Kalogianni ◽  
Haris Sideroudi
Keyword(s):  
Intraocular Pressure ◽  
Success Rate ◽  
Open Angle Glaucoma ◽  
Positive Outcome ◽  
Deep Sclerectomy ◽  
Open Angle ◽  
Pseudoexfoliative Glaucoma ◽  
Satisfactory Outcome ◽  
Department Of Ophthalmology

Purpose: To evaluate the outcomes of a new antiglaucoma surgical method, a modification of the standard deep sclerectomy, the penetrating deep sclerectomy. Participants: Patients with medically uncontrolled primary open-angle glaucoma or pseudoexfoliative glaucoma were prospectively, in a consecutive way, enrolled in this study. Methods: The study was conducted in Glaucoma Unit, Department of Ophthalmology, University of Hospital of Alexandroupolis, Greece, in 29 eyes of 29 patients. In a fornix-based surgical procedure, all eyes underwent the proposed penetrating deep sclerectomy (deep sclerectomy plus trabeculectomy) with the use of mitomycin C applied intraoperatively (0.2 mg/mL for 2 min). The follow-up period was 3 years. Ocular examination was conducted before the operation and at 1, 3, 6, 12, 18, 24, and 36 months postoperatively. Results: The average reduction in intraocular pressure at the end of follow-up was 11.24 (57.88%). The complete success rate (intraocular pressure ⩽21 mm Hg without medication) after 3 years was 58.6%. The qualified success rate (intraocular pressure ⩽21 mm Hg without or with medication) was 75.86%. Postoperatively, the mean number of medication dropped from 3.75 ± 0.89 to 0.89 ± 0.98. Low postoperative complications were recorded. Conclusion: During the 3-year follow-up period, penetrating deep sclerectomy presented very positive outcome. The addition of a controlled perforation of the trabeculo-Descemet’s membrane in deep sclerectomy, playing the role of an early goniopuncture, seems to ensure a satisfactory outcome and is not associated with additional complications.

scholarly journals CO2 Laser-Assisted Deep Sclerectomy Surgery Compared with Trabeculectomy in Primary Open-Angle Glaucoma: Two-Year Results

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Hengli Zhang ◽  
Yizhen Tang ◽  
Xiaowei Yan ◽  
Lihua Ma ◽  
Yulei Geng ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Co2 Laser ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Thin Wall ◽  
Deep Sclerectomy ◽  
Open Angle ◽  
Success Rates ◽  
Significant Difference

Purpose. To compare the effectiveness and safety of carbon dioxide (CO2) laser-assisted deep sclerectomy surgery (CLASS) and trabeculectomy (Trab) for treatment of primary open-angle glaucoma (POAG). Methods. In this retrospective and comparative study, 77 eyes of 62 patients with POAG were studied and divided into the CLASS and Trab groups. The best-corrected visual acuity (BCVA), intraocular pressure (IOP), number of medications, surgical success rate, and complications were analyzed. Results. The mean follow-up periods were 27.89 ± 2.94 months and 26.11 ± 2.06 months in the CLASS and Trab groups, respectively. 30 eyes (24 patients) underwent CLASS and 47 eyes (38 patients) underwent Trab. The BCVA in the CLASS and Trab groups was recovered to baseline at postoperative 1 week and 1 month, respectively. At last follow-up visits, a remarkable reduction in the IOP and number of medications was observed in both groups, and no significant difference was found in those between the two groups. The complete success rates were 51.7% and 47.7% in postoperative 24 months in the CLASS and Trab groups, respectively ( P > 0.05 ). There were higher rates of delayed anterior chamber formation (21.3%) and thin-wall filtrating blebs (10.6%) in the Trab group. Meanwhile, the peripheral anterior synechiae were only observed in the CLASS group, and the ratio was 30%. Conclusions. CLASS is an effective and safe treatment modality for POAG, with fewer filtering bleb-related complications and quicker visual recovery in the early postoperative stage than trabeculectomy. The efficacy of lowering intraocular pressure was similar for both procedures.

scholarly journals Longitudinal Growth Differentiation Factor 15 (GDF15) and Long-term Intraocular Pressure Fluctuation in Glaucoma: A Pilot Study

2021 ◽  
Author(s):  
Jonathan B. Lin ◽  
Arsham Sheybani ◽  
Andrea Santeford ◽  
Rajendra S. Apte
Keyword(s):  
Intraocular Pressure ◽  
Pilot Study ◽  
Open Angle Glaucoma ◽  
Glaucoma Surgery ◽  
Fold Change ◽  
Growth Differentiation Factor 15 ◽  
Post Surgery ◽  
Differentiation Factor ◽  
Prospective Longitudinal

Purpose: Growth Differentiation Factor 15 (GDF15) was previously identified as a molecular marker of retinal ganglion cell stress in rodent models of glaucoma and was elevated in the aqueous humor (AH) of patients with primary open-angle glaucoma as a possible risk factor for glaucoma progression. The purpose of this study was to determine whether changes in the AH GDF15 levels were associated with intraocular pressure (IOP) changes in eyes undergoing glaucoma surgery. Methods: Here, we performed a prospective, longitudinal pilot study in nine patients to determine whether changes in AH GDF15 levels from surgery to post-surgery follow-up were associated with IOP fluctuation. An initial AH sample was taken from the peripheral corneal paracentesis during planned glaucoma surgery, and a second sample was taken during an outpatient follow-up visit, approximately six months later. Results: There was a statistically significant correlation between GDF15 fold change and IOP standard deviation (r = 0.87, P = 0.003), IOP range (r = 0.87, P = 0.003), and maximum IOP (r = 0.86, P = 0.003). There was no correlation between the GDF15 fold change and baseline IOP (r = 0.50, P = 0.17), final IOP (r = 0.038, P = 0.92), or mean IOP (r = 0.40, P = 0.28). Conclusion: Our findings in this pilot study suggest that longitudinal changes in AH GDF15 may be associated with IOP fluctuation during the postoperative period. Further studies are necessary to corroborate these findings in a larger patient population and to explore the possibility that AH GDF15 may be used not only to improve treatment algorithms but also as a surrogate endpoint in clinical trials.

XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study

2020 ◽  
pp. 112067212095203
Author(s):  
Cosme Lavin-Dapena ◽  
Rosa Cordero-Ros ◽  
Oriana D’Anna ◽  
Isabel Mogollón
Keyword(s):  
Adverse Events ◽  
Open Angle Glaucoma ◽  
Corneal Edema ◽  
Cataract Extraction ◽  
Glaucoma Surgery ◽  
Open Label ◽  
Serious Adverse Events ◽  
Hypotensive Drugs ◽  
Single Center Study

Purpose: To evaluate the efficacy and safety of the XEN63 Gel Stent in patients with open-angle glaucoma (OAG). Methods: Prospective, nonrandomized, open-label, not-controlled, and single center study conducted on OAG patients who underwent glaucoma surgery with the XEN63 gel stent. The main outcome measure was intraocular pressure (IOP). Secondary end-points were number of topical ocular hypotensive drugs, percentage of patients achieving an IOP reduction ⩾20%, and treatment-related adverse events. Results: Eleven eyes from 11 patients were treated with XEN 63. Mean (95% confidence interval, CI) age was 78.8 (73.7–85.9). Two eyes (18.2%) underwent XEN alone, while nine eyes (81.8%) underwent combined XEN + cataract extraction (phacoemulsification). The median (95% CI) IOP reduction was 17.7% (−13.3% to 34.9%). At the end of the study 9 (81.8%) eyes had an IOP ⩽ 18 mm Hg, six of them without treatment. Six (54.6%) eyes obtained an IOP reduction ⩾20%. Compared to baseline, there was a significant reduction in the number of ocular hypotensive drugs ( p = 0.0039). There were no treatment-related serious adverse events. Early postoperative complications included diplopia (1), blood in endothelium (2), ocular hypertension (1), corneal edema (1), folds in Descemet’s membrane (1), and contact between the implant and the iris (1). All the adverse events were successfully solved without sequalae. One eye required bleb needling. Conclusion: The XEN63 implant significantly reduced both IOP and the amount of ocular hypotensive medications while maintaining a good safety profile.

iStent inject as a reasonable alternative procedure following failed trabeculectomy?

2018 ◽  
Vol 28 (6) ◽  
pp. 735-740 ◽  
Author(s):  
Anja-Maria Davids ◽  
Milena Pahlitzsch ◽  
Alexander Boeker ◽  
Necip Torun ◽  
Eckart Bertelmann ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Glaucoma Surgery ◽  
Wilcoxon Test ◽  
Open Angle ◽  
Istent Inject ◽  
Glaucoma Therapy ◽  
Significant Difference ◽  
Target Pressure

Purpose: The aim of this study is to assess the intraocular pressure lowering effect and the performance of the glaucoma therapy of the iStent inject in glaucoma patients with uncontrolled intraocular pressure after failed trabeculectomy. Methods: In this retrospective study, iStent inject implantation (Glaukos Corporation, Laguna Hills, CA, USA) was performed in 22 eyes of 21 subjects suffering from glaucoma (n = 18 primary open angle glaucoma, n = 3 pseudoexfoliation glaucoma, and n = 1 for secondary glaucoma) with an intraocular pressure above target pressure after failed trabeculectomy (mean = 9.6 ± 8.1 years; range: 1–35 years). The intraocular pressure and the number of antiglaucomatous medication were assessed preoperatively, 1 day, 6 weeks, 3 months, 6 months, and 1 year after surgery and compared to preoperative findings (SPSS v23.0; Shapiro–Wilk test, Wilcoxon test, Friedman test). Results: The results showed a significant intraocular pressure decrease from 22.5 ± 4.6 to 15.5 ± 3.4 mmHg after 1 year follow-up (p = 0.012). The glaucoma therapy was 2.6 ± 1.2 preoperatively and reduced to 2.25 ± 1.5 number of medications after 1 year (p > 0.05). There was no significant difference in the number of medication during the whole follow-up period (1 year, p = 0.012). No significant intra- or postoperative complications were reported. Conclusion: Minimal invasive glaucoma surgery (iStent inject) can offer an effective intraocular pressure reduction in advanced adult primary and secondary open angle glaucoma after failed trabeculectomy in a follow-up period of 1 year. Glaucoma therapy, however, needs to be maintained to achieve an individual target pressure and to prevent glaucoma progression. In addition, a failure rate of 27.3% makes it necessary to select carefully patients for this treatment option.

scholarly journals Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial

2020 ◽  
pp. bjophthalmol-2020-316888
Author(s):  
Philippe Denis ◽  
Christoph Hirneiß ◽  
Georges M Durr ◽  
Kasu Prasad Reddy ◽  
Anita Kamarthy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Open Angle Glaucoma ◽  
Human Study ◽  
Drainage System ◽  
Glaucoma Surgery ◽  
Glaucoma Drainage Device ◽  
Glaucoma Medication ◽  
Registration Number ◽  
Diurnal Iop

Background/AimsThe current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma.MethodsThis prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication.ResultsMean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (−40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD.ConclusionThis first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events.Trial registration numberNCT03193736.

Relationship between mean follow-up intraocular pressure, rates of visual field progression and current target intraocular pressure guidelines

2020 ◽  
pp. bjophthalmol-2020-317406
Author(s):  
Bruna Melchior ◽  
Carlos Gustavo De Moraes ◽  
Jayter S Paula ◽  
George A Cioffi ◽  
Christopher A Girkin ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Visual Field ◽  
Treatment Guidelines ◽  
Evaluation Study ◽  
Mean Deviation ◽  
Racial Groups ◽  
Current Guideline ◽  
Registration Number ◽  
The Mean

AimsTo investigate if eyes presenting intraocular pressure (IOP) within the limits of current guideline-driven target IOP indeed experience slow rates of glaucomatous visual field (VF) progression.MethodsA total of 8598 24-2 VF tests from 603 eyes from the African Descent and Glaucoma Evaluation Study with manifest glaucoma were included. The sample was split into three groups based on baseline VF mean deviation (MD): G1 (better than −5.0 dB), G2 (−5.0 to −10 dB) and G3 (worse than −10 dB). We investigated the relationship between existing target IOP guidelines and rates of MD progression in these groups.ResultsFor stable eyes, the medians and IQR of the mean follow-up IOP were G1=15.0 mmHg (IQR: 13.1 to 17.7), G2=13.2 mmHg (IQR: 11.6 to 14.3) and G3=11.9 mmHg (IQR: 10.1 to 13.8) (p<0.01). When considering the mean follow-up IOP within the limits proposed by current guidelines, the median MD slopes were: −0.20 dB/y (IQR: −0.43 to −0.02) for G1<21 mmHg, −0.19 dB/y (IQR: −0.51 to −0.01) for G2<18 mmHg and −0.15 dB/y (IQR: −0.47 to 0.05) for G3<15 mmHg (p=0.63). There were no significant differences between racial groups.ConclusionIn a sample of patients with manifest glaucoma, despite substantial variability between eyes, adherence to treatment guidelines helped slow the rates of global VF progression at various stages of disease.Trial registration numberclinicaltrials.gov Identifier: NCT00221923.

scholarly journals Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Félix Gil-Carrasco ◽  
Daniel Ochoa-Contreras ◽  
Marco A. Torres ◽  
Jorge Santiago-Amaya ◽  
Fidel W. Pérez-Tovar ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Intraocular Pressure ◽  
Pilot Study ◽  
Open Angle Glaucoma ◽  
Constant Current ◽  
Open Angle ◽  
Naive Group ◽  
Treatment Naïve ◽  
The Mean

Purpose. To determine the effect on intraocular pressure of transpalpebral specific exogenous voltages in a cohort of open-angle glaucoma patients. Methods. This is a prospective, comparative, and experimental pilot study. The electrical stimuli applied consisted of 10 Hz, biphasic, nonrectangular current pulses (100 μA) delivered from an isolated constant current stimulator. At intake, baseline IOP measurements were obtained from each eye. The measurement was repeated before and after microstimulation until the end of the treatment. Results. Seventy-eight eyes of 46 patients diagnosed with POAG were studied: 58 eyes with maximum tolerated medical treatment and 20 eyes without treatment (naïve). The mean baseline IOP on the treated POAG group was 19.25 mmHg ± 4.71. Baseline IOP on the naïve group was 20.38 mmHg ± 3.28. At the four-month follow-up visit, the mean IOP value on the treatment group was 14.41 mmHg ± 2.06 (P<0.0001). The obtained mean IOP measurement on the treatment-naïve group was 15.29 mmHg ± 2.28 (P<0.0001). Conclusions. The hypotensive response obtained using transpalpebral electrical stimulation on POAG patients, both on treatment-naïve patients and on patients receiving maximum tolerable treatment, was statistically significant when comparing basal IOP measurements to those obtained at the four-month follow-up visit.

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