Dataset Information

Diurnal Intraocular Pressure Fluctuations with Self-tonometry in Glaucoma Patients and Suspects: A Clinical Trial.

ABSTRACT: SIGNIFICANCE:This article shows that self-tonometry can provide robust measures of diurnal intraocular pressure (IOP) and also detect changes to IOP in response to treatment within a short period of monitoring. These advances in IOP monitoring may contribute to improved management of glaucoma patients and suspects. PURPOSE:The aim of this study was to prospectively investigate the utility of rebound self-tonometry performed over several weeks for detecting diurnal IOP fluctuations in glaucoma patients and suspects and also initial response to topical treatment in glaucoma patients. METHODS:Forty patients were recruited following glaucoma-specific examination. Subsequent to successful training with the iCare HOME tonometer, patients were instructed to measure IOP, in a sitting position, four times a day over 4 to 6 weeks. Date, time, laterality, and IOP downloaded from the tonometer and clinical examination data, including applanation IOP and corneal thickness, were analyzed. A user satisfaction survey was also administered at study completion. t Test and analysis of variance were used to compare groups and IOP across days. Pearson correlation was used to compare measurements to Goldmann applanation tonometry and IOP measurements from the first day/s to the overall mean IOP. RESULTS:Twenty-seven patients (18 suspects and 9 glaucoma patients) completed data collection. Patients self-measured IOP on 118 (±29) occasions for 40 (±7.4) days. Two dominant patterns of fluctuation were revealed: peak IOP upon awakening (n = 11) and at midday (n = 13). Diurnal IOP measured in the first 7 days showed strong correlation to diurnal IOP across the entire study period (r = 0.82, P < .0001). Within 24 hours of treatment commencement (latanoprost 0.005% ophthalmic solution), IOP reduced from 23.9 (±5.2) to 16.1 (±2.6) mmHg. Overall, patients rated the instrument as easy to use, although difficulties with correct alignment were expressed. CONCLUSIONS:Rebound self-tonometry demonstrated utility for measuring diurnal IOP fluctuations in most patients, hence enhancing management of patient with or at risk of developing glaucoma.

SUBMITTER: Huang J

PROVIDER: S-EPMC5794241 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Diurnal Intraocular Pressure Fluctuations with Self-tonometry in Glaucoma Patients and Suspects: A Clinical Trial.

Huang Jessie J Katalinic Paula P Kalloniatis Michael M Hennessy Michael P MP Zangerl Barbara B

Optometry and vision science : official publication of the American Academy of Optometry 20180201 2

<h4>Significance</h4>This article shows that self-tonometry can provide robust measures of diurnal intraocular pressure (IOP) and also detect changes to IOP in response to treatment within a short period of monitoring. These advances in IOP monitoring may contribute to improved management of glaucoma patients and suspects.<h4>Purpose</h4>The aim of this study was to prospectively investigate the utility of rebound self-tonometry performed over several weeks for detecting diurnal IOP fluctuations ...[more]

PMID: 29370022

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Project description:PurposeThe SALUS study aims to improve the healthcare situation for glaucoma patients in Germany. In order to detect diurnal intraocular pressure (IOP) fluctuations, inpatient monitoring of IOP in an eye hospital for a minimum of 24 h is the current standard. SALUS assesses the benefits of a new form of outpatient care, where IOP can be measured by the patients themselves at home using a self-tonometer. This approach should promote the patient's health competence and empowerment within the healthcare system while reducing treatment costs.MethodsThe SALUS study is a randomized controlled, open non-inferiority trial, alongside an economic analysis, determining whether outpatient monitoring of IOP with self-tonometry is at least as effective as current standard care and would reduce treatment costs. Participants (n = 1980) will be recruited by local ophthalmologists in the area of Westphalia-Lippe, Germany, and randomized to receive 7-day outpatient or 24-h inpatient monitoring. Participants in both study arms will also receive 24-h blood pressure monitoring. Furthermore, patient data from both study groups will be collected in an electronic case file (ECF), accessible to practitioners, hospitals, and the study participants. The primary endpoint is the percentage of patients with IOP peaks, defined as levels 30% above the patient-specific target pressure. Data will also be collected during initial and final examinations, and at 3, 6, and 9 months after the initial examination.ResultsThe study implementation and trial management are represented below.ConclusionSALUS is a pioneering prospective clinical trial focused on the care of glaucoma patients in Germany. If SALUS is successful, it could improve the healthcare situation and health literacy of the patients through the introduction of various telemedical components. Furthermore, the approach would almost certainly reduce the treatment costs of glaucoma care.Trial registrationClinicalTrials.gov ID: NCT04698876, registration date: 11/25/2020.Drks-idDRKS00023676, registration date: 11/26/2020.

Project description:BACKGROUND:Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). METHODS:The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65?years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36?months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36?months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. DISCUSSION:To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. TRIAL REGISTRATION:ClinicalTrials.gov NCT04296916 . Registered on 4 March 2020.

Project description:BACKGROUND:To compare the effect of selective laser trabeculoplasty (SLT) and travoprost on 24-hour IOP fluctuations in primary open-angle glaucoma (POAG) and normal-tension glaucoma (NTG). METHODS:Sixty eyes were included. Sixteen and 14 eyes of POAG patients were randomized to receive 360° SLT or 0.004% travoprost, respectively. Fourteen and 16 eyes of NTG patients were randomized to receive either SLT or travoprost, respectively. The 24-hour IOP data were collected before treatment and 6 to 8 weeks after treatment. IOP was measured at 2?hours intervals in the sitting position during daytime (9 AM to 7 PM) and in the supine position during nighttime (9 PM to 7 AM). Main outcome measure was the percentage of eyes that achieved posttreatment 24-hour IOP fluctuations <3?mm?Hg. Success in fluctuation reduction was defined as at least a 50% reduction in these fluctuations. RESULTS:Fifty-eight eyes were analyzed. Overall, eyes in the SLT and the travoprost groups achieved a significant reduction in IOP compared with the baseline IOP values (-3.7?mm Hg [P?=?0.002] vs -4.1?mm Hg [P?<?0.001], respectively). There was no significant difference in IOP reduction in both groups according to type of glaucoma. During the diurnal period, 100% of POAG eyes in the travoprost group achieved posttreatment IOP fluctuations <3?mm Hg, and 87% of eyes in the SLT group achieved the same level of fluctuations (P?<?0.001). Ninety-six percent of NTG eyes in the travoprost group, and 82% of eyes in the SLT group had IOP fluctuations <3?mm Hg (P?=?0.01). Success in fluctuation reduction was 75% and 92% for the SLT and travoprost groups, respectively (P?=?0.005). The effect of travoprost on IOP reduction in POAG and NTG patients was significant both during the daytime and the nighttime, while the SLT's effect was significant only during the nighttime. CONCLUSIONS:Both travoprost and SLT can significantly reduce the IOP in patients with POAG and NTG. Based on habitual positions, travoprost better controls IOP fluctuations than SLT, especially during the daytime.

Project description:ImportanceThe ability of patients to measure their own intraocular pressure (IOP) would allow more frequent measurements and better appreciation of peak IOP and IOP fluctuation.ObjectiveTo examine whether patients with glaucoma can perform self-tonometry using a rebound tonometer and examine patient acceptability.Design, setting, and participantsAn observational study in which IOP was assessed using Goldmann applanation tonometry and a rebound tonometer. Consecutive patients were provided with a patient information sheet and those consenting to take part in the study received standardized self-tonometry training and were then instructed to measure their own IOP under observation. This study was conducted at a glaucoma clinic at a university hospital from March 1, 2016, to December 30, 2016, and included both eyes of 100 patients with glaucoma or ocular hypertension.Main outcomes and measuresThe percentage of patients who could successfully perform self-tonometry. Complete success was defined by a good technique and an IOP reading within 5 mm Hg of that obtained by a clinician using the same device. A 3-item questionnaire was used to examine perceptions of self-tonometry among patients.ResultsAmong the 100 patients, the mean (SD) age was 67.5 (10.9) years (53% female). A total 73 of 100 patients (73%) met the complete success criteria. An additional 6 patients could use the device but had IOP readings greater than 5 mm Hg different from those obtained by the clinician. On average, IOP by the rebound tonometer was 2.66 mm Hg lower than Goldmann applanation tonometry (95% limits of agreement, -3.48 to 8.80 mm Hg). The IOPs with the rebound tonometer were similar whether obtained by self-tonometry or investigator, with excellent reproducibility with an intraclass correlation coefficient of 0.903 (95% CI, 0.867-0.928). A total of 56 of 79 successful or partially successful patients (71%) felt self-tonometry was easy, with 73 of 79 (92%) reporting self-tonometry to be comfortable, and a similar number happy to perform self-tonometry in the future.Conclusions and relevanceMost patients could perform self-tonometry and the method was acceptable to patients. Self-tonometry has the potential to improve patient engagement, while also providing a more complete picture of IOP changes over time.

Dataset Information

Diurnal Intraocular Pressure Fluctuations with Self-tonometry in Glaucoma Patients and Suspects: A Clinical Trial.

Publications

Diurnal Intraocular Pressure Fluctuations with Self-tonometry in Glaucoma Patients and Suspects: A Clinical Trial.

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