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1.
J Glaucoma ; 2024 May 06.
Artículo en Inglés | MEDLINE | ID: mdl-38709193

RESUMEN

PURPOSE: This study assesses morphological characteristics using SD-OCT in patients with hypotony maculopathy (HM) following glaucoma filtering surgery and evaluates the results of its treatment. MATERIAL AND METHODS: Retrospective analysis of all HM patients between January 2019 and March 2023. Inclusion criteria consisted of both pre-operative and post-revision SD-OCT images of the macula and the presence of HM as observed on OCT images preoperatively. HM was graded according to its appearance in OCT both pre- and post-revision surgery. Change in visual acuity and IOP were assessed. RESULTS: 45 eyes of 45 patients were included. 21 eyes had HM limited to retinal pigment epithelium (RPE), 18 eyes had involvement of RPE and photoreceptor layers and 6 eyes had additional intra- or subretinal edema. After revision surgery with IOP elevation, 64% of eyes had complete HM regression with no HM signs in OCT imaging. 80% of patients achieved at least one grade improvement in HM. Preoperative visual acuity increased from 0.7±0.4 (logMAR) to 0.4±0.4 at 2 weeks postoperatively, over the course of an increase of IOP from 3.5±1.8 mmHg to 17.1±10.6 mmHg at day one. Eyes with complete HM regression had higher IOP at day 1 compared to those without improvement (P=0.04). The median time between HM onset and revision was 10.0 days for those with complete regression and 27 days for those without improvement (P=0.04). CONCLUSIONS: Bleb revision procedures for HM following glaucoma filtering surgery show promising outcomes, including notable improvements in visual acuity and IOP. The timing of revision surgery appears to influence outcome. In our study earlier intervention was associated with better results. Even delayed surgeries can lead to an improvement, although complete morphological restoration may not be achieved in advanced grades of HM.

2.
Artículo en Inglés | MEDLINE | ID: mdl-38662577

RESUMEN

PURPOSE: To investigate the long-term astigmatism after combined non-penetrating glaucoma surgery (NPGS) and implantation of the first miniaturized suprachoroidal intraocular pressure (IOP) sensor EYEMATE-SC. SETTING: The study was conducted in five medical centers in two different countries. DESIGN: Retrospective multicenter clinical study. METHODS: Astigmatism of patients instrumented with the EYEMATE-SC IOP sensor was assessed over a follow-up period of three years. Refraction and corrected distance visual acuity (CDVA) were obtained preoperatively, after 6 months, 1, 2, and 3 years. A canaloplasty-operated patient cohort served as control. Astigmatism was evaluated using 3-dimensional power vector analysis involving the spherical equivalent M, and the Jackson crossed cylinder projections J0 and J45. Exclusion criteria included neovascular and angle-closure glaucoma, myopia, axial length outside 22 to 26 mm, other ocular diseases, prior glaucoma surgery, other ocular surgery within 6 months (cataract surgery within 3 months) prior to NPGS, serious generalized conditions, and other active medical head/neck implants. RESULTS: Multivariate analysis indicated no changes in astigmatism along the observation period in both the EYEMATE-SC (n = 24) and the canaloplasty (n = 24) group (P > 0.05 or nonsignificant after Bonferroni correction). Astigmatism was unchanged between the EYEMATE-SC and the canaloplasty group at all time points (P > 0.05). CDVA didn't change along the observation period of three years in each of both groups (P > 0.05). CONCLUSIONS: Despite its suprachoroidal localization, the present study indicates that the miniaturized EYEMATE-SC IOP sensor doesn't negatively affect the long-term astigmatism after combined implantation with NPGS.

3.
Ophthalmol Glaucoma ; 2024 Feb 27.
Artículo en Inglés | MEDLINE | ID: mdl-38423388

RESUMEN

TOPIC: To identify patient-reported outcome measures (PROMs) that have been used in children and adolescents with glaucoma and to evaluate their methodologic quality. CLINICAL RELEVANCE: Childhood glaucoma impairs vision and quality of life (QoL) throughout all stages of life. Thus, a PROM needs to cover many different age groups and topics. Various instruments have been used to evaluate patient-reported outcomes (PROs) in patients with childhood glaucoma, however, it is unclear which PROM has the highest methodologic quality and complies best with the needs of patients with childhood glaucoma. METHODS: A systematic literature review was performed searching MEDLINE (PubMed), the Cochrane Library, Web of Science, and PsycINFO (EBSCO). We included peer-reviewed full-text articles of the past 10 years in English, German, or Spanish language that reported PROMs in children with glaucoma. The study selection and methodologic quality assessment of the identified PROMs was performed by 2 independent reviewers using a 7-point checklist. The content was mapped onto the World Health Organization International Classification of Functioning, Disability and Health. The systematic review was prospectively registered in PROSPERO (ID CRD42022353936). RESULTS: The search strategy retrieved 3295 matches. A total of 2901 studies were screened, and 11 relevant articles were identified using 10 different instruments. The instruments addressed functional visual ability, vision-related QoL, health-related QoL, and life satisfaction. Six instruments were applicable for the use in children. Seven of the questionnaires received the highest number of positive ratings (5/7). None of the instruments considered the views of patients with childhood glaucoma during their development. CONCLUSION: This systematic review provides a descriptive catalog of vision-specific and generic health PRO instruments that have been used in childhood glaucoma cohorts. An instrument specifically developed for childhood glaucoma is lacking which might result in missing important factors, such as permanent treatment with eye drops, repeated surgeries, and heritability of the disease, when investigating the QoL in children with glaucoma. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

4.
Am J Ophthalmol ; 262: 170-177, 2024 Feb 14.
Artículo en Inglés | MEDLINE | ID: mdl-38360336

RESUMEN

PURPOSE: This study explores associations between fetal growth restriction or excessive fetal growth, along with perinatal factors on the optic nerve head morphology in adulthood. DESIGN: Retrospective cohort study. METHODS: This retrospective cohort study involved a prospective ophthalmological examination of individuals born at full term (with a gestational age of ≥37 weeks) from 1969 to 2002. Each participant underwent nonmydriatic fundus camera photography to capture images of the optic discs, followed by manual measurements. The vertical cup-to-disc ratio (VCDR) and optic disc area were examined and analyzed in relation to the baby's birth weight relative to the gestational age. These categories included those with former moderate (birth weight percentile between the 3rd and <10th), severe SGA (below the third percentile), normal (AGA, 10th-90th percentile), and moderately (birth weight >90th-97th percentile) and severely (birth weight >97th percentile) large for gestational age (LGA) adults within the age range of 18 to 52 years. RESULTS: Overall, 535 eyes of 280 individuals (age 29.7 ± 9.2 years, 144 females) born at full term were included. Multivariable analysis showed a significant association between a larger VCDR and the severe SGA group (B = 0.05, 95% CI 0.01-0.10; P = .02). In the univariable model, placental insufficiency was associated with VCDR (B = 0.10, 95% CI 0.01-0.19; P = .03). Other perinatal factors did not demonstrate an association with VCDR. Furthermore, there was an indication of an association suggesting a smaller optic disc area in individuals born moderately SGA at full term (B = -0.17, 95% CI -0.33 to -0.001; P = .05). CONCLUSIONS: This study provides evidence that individuals born at-term with severe SGA have an increased VCDR, suggesting that fetal growth restriction has a lasting impact on optic disc morphology independent of prematurity throughout adulthood.

5.
Invest Ophthalmol Vis Sci ; 65(1): 12, 2024 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-38175640

RESUMEN

Purpose: To investigate the longitudinal change in intraocular pressure (IOP) over 5 years and its relationship with cardiovascular parameters in a population-based sample in Germany. Methods: The Gutenberg Health Study is a prospective, observational, single-center cohort study. The sample was equally stratified for sex, residence, and age decade. IOP was measured with noncontact tonometry at baseline and at 5-year follow-up. Cardiovascular parameters, including body mass index (BMI), systolic blood pressure, and diabetes status, were assessed. Participants without IOP measurement at one time point, who were taking IOP-lowering medications, or who had ophthalmic surgery during the 5-year follow-up interval were excluded, as well as those with glaucoma diagnosis. Univariable and multivariable linear regression analyses were conducted. Results: This analysis included 9633 participants (48.9% female). The mean IOP increased from 14.04 ± 2.78 mmHg at baseline to 14.77 ± 2.92 mmHg at 5-year follow-up (P < 0.001). In multivariable linear regression analyses, an increase in BMI was associated with an increase in IOP over time (P < 0.001), whereas a higher baseline BMI was associated with a lower IOP change (P < 0.001). Higher age and male sex were associated with higher IOP change (P < 0.001). A change in systolic blood pressure was associated with IOP change, whereas baseline systolic blood pressure and diabetes status were not associated. Conclusions: This population-based study found a relationship between IOP change over 5 years and BMI and systolic blood pressure change, respectively. These findings suggest the importance of monitoring cardiovascular risk factors in IOP management.


Asunto(s)
Diabetes Mellitus , Glaucoma , Presión Intraocular , Femenino , Humanos , Masculino , Estudios de Cohortes , Estudios Prospectivos
7.
BMC Med Educ ; 23(1): 723, 2023 Oct 03.
Artículo en Inglés | MEDLINE | ID: mdl-37789302

RESUMEN

BACKGROUND: Point-of-care Ocular Ultrasound (POCOUS) has gained importance in emergency medicine and intensive care in recent years. This work aimed to establish and evaluate a dedicated ultrasound education program for learning POCOUS-specific skills during medical studies at a university hospital. METHODS: The blended learning-based program (6 teaching units) based on recent scientific publications and recommendations was developed for students in the clinical part of their medical studies. Experts and trainers consisted of physicians from the Ear-Nose-Throat, radiology, ophthalmology and neurology specialties as well as university educational specialists. Lecture notes containing digital video links for preparation was produced as teaching material. In total, 33 students participated in the study. The education program, including the teaching materials, motivation and subjective gain in competency, was evaluated with the aid of a questionnaire (7-point Likert response format). Objective learning success was assessed on the basis of pre- and post-tests. These covered the skill areas: "anatomical basics", "ultrasound basics", "understanding of cross-sectional images", "normal findings" and "pathology recognition". RESULTS: In the objective assessment of image interpretation, the participants improved significantly (p < 0.001) from pre- to post-test with a large effect size (Cohen's d = 1.78, effect size r = 0.66). The evaluations revealed a high level of satisfaction with the course concept, teaching materials and the tutors. In addition, a high level of motivation was recorded in relation to continuing to study "ultrasound diagnostics" and "ophthalmologic diseases". A significant (p < 0.01) positive gain was also achieved in terms of the subjective assessment of competency. This covers areas such as expertise, sonographic anatomy and performing a POCOUS examination as well as recognizing retinal detachment, globe perforation and increased optic nerve sheath diameter. CONCLUSION: The results of this feasibility study show that medical students accept and support a POCOUS-specific education program and are able to develop a higher objective and subjective level of competency. Future transfer to other sites and larger groups of participants seems feasible.


Asunto(s)
Estudiantes de Medicina , Humanos , Sistemas de Atención de Punto , Curriculum , Ultrasonografía , Aprendizaje , Competencia Clínica
8.
Ophthalmologie ; 120(11): 1088-1097, 2023 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-37847376

RESUMEN

BACKGROUND: Glaucoma is not a rare entity but because very few symptoms occur and visual field defects are frequently first recognized at a late stage, a large proportion of glaucoma diseases remain undetected. The aim of this study was to identify the proportion of undiagnosed glaucoma in German population-based cohort studies and to contextualize them in the context of the literature. MATERIAL AND METHODS: The prevalence of glaucoma in the Gutenberg Health Study (GHS) and the age-related investigations on health of the University of Regensburg (AugUR) was evaluated based on visual field examinations and optic disc color photography according to the ISGEO criteria. Furthermore, the self-reported glaucoma diagnoses were collected and the proportion of undiagnosed glaucoma was determined. RESULTS: The proportion of undiagnosed glaucoma was 55% in the GHS, and 53% in the AugUR study. The results correlate with results from previous studies from other countries in which the proportion of unrecognized glaucoma ranged from 33% to 78%. In the GHS and the AugUR study the proportion of undiagnosed glaucoma was higher in younger age groups and in women. DISCUSSION: Roughly every second case of glaucoma is undetected. As the symptoms are often nonspecific or take a long time to appear, there is a risk of advanced glaucomatous visual field defects or blindness due to a lack of glaucoma awareness. Studies have shown that a systematic screening can halve this risk.


Asunto(s)
Glaucoma , Disco Óptico , Humanos , Femenino , Presión Intraocular , Glaucoma/diagnóstico , Pruebas del Campo Visual , Campos Visuales , Disco Óptico/diagnóstico por imagen , Trastornos de la Visión/diagnóstico
9.
Ophthalmologie ; 120(11): 1107-1116, 2023 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-37880486

RESUMEN

This article provides an overview of real-world outcomes in glaucoma surgical procedures. While randomized clinical trials provide valuable insights, they do not fully reflect real-world clinical practice. Real-world studies enable the evaluation of outcomes in uncontrolled settings and play a crucial role in counselling and decision-making for glaucoma treatment. By examining real-world data the article aims to identify rare adverse events that may go unnoticed in controlled clinical trials. The focus is on assessing the effectiveness and safety of glaucoma surgical procedures beyond the controlled trial setting.


Asunto(s)
Glaucoma de Ángulo Abierto , Humanos , Glaucoma de Ángulo Abierto/cirugía , Procedimientos Quirúrgicos Oftalmológicos
10.
PLoS One ; 18(7): e0286318, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37406023

RESUMEN

PURPOSE: To assess long-time results of primary surgical treatment in children with glaucoma after congenital cataract surgery. METHODS: A retrospective study of 37 eyes from 35 children with glaucoma after congenital cataract surgery, who underwent surgery between 2011 and 2021 at the Childhood Glaucoma Center, University Medical Center Mainz, Germany. Only children, who received a primary glaucoma surgery in our clinic within the given time (n = 25) and had at least one-year follow-up (n = 21), were included in the further analysis. The mean follow-up time was 40.4±35.1 months. The primary outcome was the mean reduction in IOP (in mmHg) from baseline to follow-up visits after the surgery, measured with Perkins tonometry. RESULTS: 8 patients (38%) were treated with probe trabeculotomy (probe TO), 6 (29%) with 360° catheter-assisted trabeculotomy (360° TO) and 7 (33%) with cyclodestructive procedures. IOP was significantly reduced after probe TO and 360° TO after 2 years, from 26.9 mmHg to 17.4 mmHg (p<0.01) and 25.2 mmHg to 14.1 mmHg (p<0.02), respectively. There was no significant IOP reduction after cyclodestructive procedures after 2 years. Both, probe TO and 360° TO led descriptively to eye drops reduction after 2 years, from 2.0 to 0.7 and 3.2 to 1.1. The reduction was not significant. CONCLUSIONS: In glaucoma after congenital cataract surgery, both trabeculotomy techniques, lead to good reduction of IOP after 2 years. There is a need for a prospective study with comparison to the use of glaucoma drainage implants.


Asunto(s)
Catarata , Glaucoma , Trabeculectomía , Niño , Humanos , Presión Intraocular , Estudios Retrospectivos , Resultado del Tratamiento , Glaucoma/congénito , Trabeculectomía/métodos , Catarata/terapia , Catarata/etiología , Estudios de Seguimiento
11.
Invest Ophthalmol Vis Sci ; 64(7): 15, 2023 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-37289170

RESUMEN

Purpose: To investigate the association between intraocular pressure (IOP) and climate parameters. Methods: The Gutenberg Health Study (GHS) is a population-based cohort study in Mainz, Germany. Participants underwent two comprehensive ophthalmologic examinations (baseline visit and five-year follow up) including non-contact tonometry, objective refraction, pachymetry, perimetry, and fundus imaging in the time frame of 2007 to 2017. The respective climate parameters were assessed at the University Mainz including temperature, air humidity, and air pressure. Associations of IOP and climatic parameters were computed using component models and cross-correlation plots. Multivariable regression analysis was performed to adjust for age, sex, body mass index, diabetes, central corneal thickness, and systolic blood pressure. To further explore the link between systolic blood pressure, temperature, and IOP, an effect mediation analysis was conducted. Results: A total of 14,632 participants (age 55 ± 11 years at baseline, 49.1% female) were included in this analysis. Mean IOP was 14.24 ± 2.8 mm Hg at baseline. There was a similar periodic change in IOP and in temperature, as shown in the component models. IOP was not associated with air humidity. In univariable and multivariable regression analyses we found a significant association between lower IOP during the summer months with higher air temperature (B = -0.011, P < 0.001). This could be partially explained in mediation analysis by lower systolic blood pressure at higher air temperature. Furthermore, IOP was associated with air pressure in univariable (B = 0.005, P = 0.04.) and multivariable models (B = 0.006, P = 0.03). Conclusions: There is a periodic annual change of IOP with higher values in winter and lower values in summer supporting the hypothesis of an impact of environmental temperature on IOP, which is partly mediated by lower systolic blood pressure in summer.


Asunto(s)
Oftalmopatías , Presión Intraocular , Humanos , Femenino , Adulto , Persona de Mediana Edad , Anciano , Masculino , Estudios de Cohortes , Tonometría Ocular , Presión Sanguínea/fisiología
12.
J Glaucoma ; 32(8): 681-685, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-37327469

RESUMEN

PRCIS: After the open bleb revision following PreserFlo, the mean postoperative intraocular pressure (IOP) was lowered from 26.4 ± 9.9 mm Hg to 12.9 ± 5.6 mm Hg at 1 month and 15.9 ± 4.1 mm Hg at 12 months. PURPOSE: The purpose of this study was to evaluate the effectiveness and safety of an open bleb revision with mitomycin- C (MMC) for bleb fibrosis after PreserFlo MicroShunt implantation. PATIENTS AND METHODS: We performed a retrospective analysis of 27 consecutive patients with bleb fibrosis after PreserFlo MicroShunt Implantation that underwent an open revision with MMC 0.2 mg/mL applied for 3 minutes at the Department of Ophthalmology of the Mainz, University Medical Center, Mainz, Germany. Demographic data, such as age, sex, glaucoma type, number of glaucoma medications, IOP before and after PreserFlo implantation and revision, complications, and reoperations within 12 months, were analyzed. RESULTS: Twenty-seven patients (27 eyes) received an open revision after previous PreserFlo Microshunt implantation and consecutive bleb fibrosis. The mean preoperative IOP was 26.4 ± 9.9 mm Hg before revision, 7.0 ± 2.7 mm Hg ( P < 0.001) in the first week after the revision, and 15.9 ± 4.1 mm Hg at 12 months ( P = 0.02). Four patients needed IOP-lowering medication after 12 months. One patient had a positive Seidel test and needed a conjunctival suture. Four patients required a second procedure due to recurring bleb fibrosis. CONCLUSIONS: At 12 months, open revision with MMC for bleb fibrosis after failed PreserFlo implantation effectively and safely reduced IOP with a similar medication burden.


Asunto(s)
Glaucoma , Trabeculectomía , Humanos , Lactante , Presión Intraocular , Estudios Retrospectivos , Glaucoma/cirugía , Glaucoma/tratamiento farmacológico , Tonometría Ocular , Mitomicina/uso terapéutico , Fibrosis , Resultado del Tratamiento
13.
BMJ Open ; 13(2): e068403, 2023 02 03.
Artículo en Inglés | MEDLINE | ID: mdl-36737088

RESUMEN

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.


Asunto(s)
Catarata , Glaucoma de Ángulo Abierto , Trabeculectomía , Humanos , Trabeculectomía/métodos , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Estudios Retrospectivos , Ojo , Presión Intraocular , Mitomicina/uso terapéutico , Catarata/complicaciones , Resultado del Tratamiento , Estudios de Seguimiento
14.
Ophthalmologie ; 120(3): 335-344, 2023 Mar.
Artículo en Alemán | MEDLINE | ID: mdl-36821055

RESUMEN

Glaucoma in infancy and childhood is a rare disease. An immediate diagnosis and treatment are absolutely necessary to prevent blindness of affected children. Childhood glaucoma is characterized by a heterogeneous phenotype: besides primary congenital glaucoma, secondary types often exist and the individualized treatment requires an experienced interdisciplinary team. The pathogenesis is not always discernible and genetic alterations sometimes cause the disease. A surgical procedure is usually necessary to lower the intraocular pressure. Refractive and orthoptic care are equally important to avoid amblyopia. This article gives an overview of childhood glaucoma and outlines the most important diagnostic and therapeutic aspects.


Asunto(s)
Glaucoma , Hidroftalmía , Trabeculectomía , Humanos , Glaucoma/congénito , Hidroftalmía/complicaciones , Presión Intraocular , Trabeculectomía/efectos adversos , Tonometría Ocular/efectos adversos
15.
Life (Basel) ; 13(2)2023 Feb 13.
Artículo en Inglés | MEDLINE | ID: mdl-36836873

RESUMEN

BACKGROUND: To evaluate the long-term efficacy and safety of modified canaloplasty versus trabeculectomy in open-angle glaucoma. METHODS: In total, 210 subjects with open-angle glaucoma were included. 70 were treated with Mitomycin C-augmented modified canaloplasty with enhanced subconjunctival filtration and 140 with Mitomycin C-augmented trabeculectomy. Cases were matched 1:2 by sex and age. RESULTS: In canaloplasty and trabeculectomy groups, 61.4% and 57.9% of participants were female. Mean age was 60.0 ± 13.9 and 63.0 ± 12.2 years, median follow-up time was 4.6 [IQR 4.3, 5.05] years and 5.8 [IQR 5.4, 6.3]. Strict success was achieved in 20.0% and 56.4%, complete success in 24.3% and 66.4%, and qualified success in 34.3% and 73.6% (each p < 0.001). Kaplan-Meier survival analysis showed a better survival probability for trabeculectomy than for canaloplasty (p < 0.001) and Cox regression analysis revealed an HR of 6.03 (95%-CI 3.66, 9.93, p < 0.001) after canaloplasty. Trabeculectomy showed superiority in terms of IOP decrease (9.2 ± 7.9 mmHg vs. 13.7 ± 10.4 mmHg, p = 0.002), use of AGM (50.0% vs. 10.7%, p < 0.001), and the number of revision surgeries (41.4% vs. 21.4%, p = 0.004). Occurrence of complications was similar in both groups (14.5% vs. 7.5%, p = 0.19). CONCLUSIONS: Trabeculectomy showed superiority in efficacy and equality in safety compared to modified canaloplasty.

16.
Ophthalmology ; 130(3): 304-312, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36202141

RESUMEN

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Asunto(s)
Glaucoma de Ángulo Abierto , Presión Intraocular , Humanos , Estudios Prospectivos , Reproducibilidad de los Resultados , Tonometría Ocular
17.
Br J Ophthalmol ; 107(4): 518-524, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-34772665

RESUMEN

AIM: To 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). METHODS: Prospective, 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). RESULTS: The 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). CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. TRIAL REGISTRATION NUMBER: NCT03756662.


Asunto(s)
Glaucoma de Ángulo Abierto , Presión Intraocular , Humanos , Glaucoma de Ángulo Abierto/diagnóstico , Glaucoma de Ángulo Abierto/cirugía , Estudios Prospectivos , Tonometría Ocular
19.
Ophthalmologie ; 119(10): 1000-1005, 2022 Oct.
Artículo en Alemán | MEDLINE | ID: mdl-36074170

RESUMEN

BACKGROUND: Trabeculectomy (TE) remains one of the most frequently performed glaucoma procedures. This surgery enables sufficient reduction of intraocular pressure (IOP) and freedom from using eye drops; however, complication management and time-consuming postoperative care make many ophthalmic surgeons reluctant to include TE in their treatment regimen. AIM: This review presents the value of TE compared to other forms of filtering and nonfiltering glaucoma surgery. CONCLUSION: The use of TE is still the most effective method for lowering IOP and in comparison to other forms of glaucoma surgery in most cases enables freedom from eye drops with a subsequent high quality of life. Postoperative complications occur more frequently, but usually heal spontaneously or can be treated adequately and safely by surgery; however, TE requires intensive postoperative care, which should not be neglected. Repeated surgery due to insufficient IOP reduction is less frequent compared to other forms of glaucoma surgery.


Asunto(s)
Glaucoma , Trabeculectomía , Glaucoma/cirugía , Humanos , Presión Intraocular , Soluciones Oftálmicas , Calidad de Vida , Trabeculectomía/métodos
20.
Am J Ophthalmol ; 244: 88-97, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-35932823

RESUMEN

PURPOSE: This study investigated whether prematurity and associated factors or prenatal growth restriction have long-term effects on the peripapillary retinal nerve fiber layer (pRNFL) in adulthood. DESIGN: Retrospective cohort study. METHODS: The Gutenberg Prematurity Eye Study (GPES) is a retrospective cohort study with a prospective ophthalmologic examination in Germany. Selected individuals born term and preterm (age 18-52 years) were examined with spectral-domain optical coherence tomography (SD-OCT) in adulthood, and perinatal medical charts were reviewed. The pRNFL thickness was measured using SD-OCT. Univariate and multivariable linear regression analyses were conducted to investigate associations between pRNFL and gestational age (GA; categorical), birth weight percentile (categorical), retinopathy of prematurity (ROP) occurrence, and treatment and other perinatal parameters with adjustment for age, sex, and spherical equivalent. RESULTS: In total, 766 eyes of 406 preterm and full-term individuals were included (mean age 28.4 ± 8.6 years, 228 females). After adjustment for age, sex, and spherical equivalent, global pRNFL thinning was associated with moderate (GA = 33-36 wk, ß = -4.68, P < .001), very (GA = 29-32 wk, ß = -5.72, P < .001), and extreme (GA ≤ 28 wk, ß = -8.69, P < .001) prematurity but not with low birth weight percentile (<25th percentile, P = .9) and ROP occurrence (P = .9) in multivariable analysis. ROP treatment was associated with increased pRNFL in the temporal sector (P = .002). Maternal smoking during pregnancy showed an association with pRNFL thinning (P = .07). CONCLUSION: Our data indicate that the more preterm individuals are born the more pRNFL thinning occurs, whereas prenatal growth restriction and postnatal occurrence of ROP show less effects on pRNFL thickness. Furthermore, individuals with severe ROP with treatment but not lower ROP stages without treatment showed an increased temporal pRNFL thickness.


Asunto(s)
Enfermedades del Recién Nacido , Retinopatía de la Prematuridad , Recién Nacido , Adulto , Femenino , Humanos , Adulto Joven , Adolescente , Persona de Mediana Edad , Retinopatía de la Prematuridad/diagnóstico , Estudios Prospectivos , Estudios Retrospectivos , Agudeza Visual , Tomografía de Coherencia Óptica/métodos , Recién Nacido de Bajo Peso , Fibras Nerviosas
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