Dataset Information

Effect of treatment on the rate of visual field change in the ocular hypertension treatment study observation group.

ABSTRACT: PURPOSE:The goal in this study was to compare rates of visual field (VF) change before and after the initiation of treatment in participants originally randomized to the observation arm of the Ocular Hypertension Treatment Study (OHTS). METHODS:We included OHTS participants originally randomized to observation and excluded those who reached non-POAG endpoints. VF progression was determined using trend analysis. Global and localized rates of VF change were calculated based on linear regression over time of mean deviation (MD) and threshold sensitivity values for each test location. MD rates (MDR) and pointwise linear regression (PLR) analysis were also assessed using six VF tests before and after the initiation of treatment. A PLR endpoint was defined as a VF test location progressing faster than -0.5 dB/year at P < 0.01. RESULTS:We included 780 eyes from 432 OHTS participants. Following the initiation of treatment, the mean MDR decreased from -0.23 ± 0.6 to -0.06 ± 0.5 dB/year (P < 0.01) and the number of VF locations reaching a PLR endpoint decreased from 2.13 ± 6.0 to 1.00 ± 4.0 (P < 0.01). The benefit of treatment was significant both among participants who did not convert (-0.17 ± 0.6 vs. -0.01 ± 0.5 dB/year, P < 0.01) and among those who converted to glaucoma (-0.51 ± 0.8 vs. -0.27 ± 0.7 dB/year, P < 0.01) based on the OHTS event-based endpoint. CONCLUSIONS:The initiation of ocular hypotensive medication among OHTS participants originally randomized to observation significantly reduced the velocity of VF progression.

SUBMITTER: De Moraes CG

PROVIDER: S-EPMC3342789 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Effect of treatment on the rate of visual field change in the ocular hypertension treatment study observation group.

De Moraes Carlos Gustavo CG Demirel Shaban S Gardiner Stuart K SK Liebmann Jeffrey M JM Cioffi George A GA Ritch Robert R Gordon Mae O MO Kass Michael A MA

Investigative ophthalmology & visual science 20120402 4

<h4>Purpose</h4>The goal in this study was to compare rates of visual field (VF) change before and after the initiation of treatment in participants originally randomized to the observation arm of the Ocular Hypertension Treatment Study (OHTS).<h4>Methods</h4>We included OHTS participants originally randomized to observation and excluded those who reached non-POAG endpoints. VF progression was determined using trend analysis. Global and localized rates of VF change were calculated based on linea ...[more]

PMID: 22395889

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Project description:PurposeLongitudinal testing plays a key role in glaucoma management. Variability between visits hampers the ability to monitor progression. It has previously been shown that average intraocular pressure (IOP) exhibits seasonal fluctuations. This study examines whether visual field sensitivity also exhibits seasonal fluctuations and seeks to determine whether such fluctuations are correlated to seasonal IOP effects.DesignComparative case series.ParticipantsA total of 33 873 visits by 1636 participants enrolled in the Ocular Hypertension Treatment Study. Participants were split into 6 geographic zones according to the prevailing climate in their location.TestingAt each visit, standard automated perimetry was conducted on each eye, and IOP was measured.Main outcome measuresMixed effects regression models were formed to look for sinusoidal periodic effects on the change in perimetric mean deviation since the last visit (?MD) and on IOP, both overall and within each zone.ResultsWhen all the data were included, a significant seasonal effect on ?MD was found with magnitude 0.06 dB, peaking in February (P < 0.001). Five of the 6 geographic zones exhibited significant seasonal effects on ?MD, peaking between January and April, with magnitudes ranging from 0.04 dB (P = 0.049) to 0.21 dB (P < 0.001). Zones with greater climactic variation showed larger seasonal effects on ?MD. All 6 zones exhibited a seasonal effect on IOP, peaking in January or February, with magnitudes ranging from 0.14 to 0.39 mmHg (P ? 0.02 in all cases). However, there was no evidence of a significant association between the magnitudes or dates of peaks of the 2 seasonal effects.ConclusionsThe mean deviation was significantly higher in winter than in summer. There is no evidence of an association with seasonal IOP fluctuations. The cause of the seasonal effect on visual field sensitivity is unknown. These findings may help shed light on the glaucomatous disease process and aid efforts to reduce test-retest variability.

Project description:PurposeTo compare rates of topographic change in ocular hypertensive eyes that develop primary open-angle glaucoma (POAG) compared to eyes that do not, and to identify factors that influence the rate of change.DesignLongitudinal, randomized clinical trial.MethodsFour hundred forty-one participants (832 eyes) in the Confocal Scanning Laser Ophthalmoscopy Ancillary Study to the Ocular Hypertension Treatment Study were included. POAG was defined as repeatable visual field, photography-based optic disc changes, or both. The rate of topographic change in the 52 participants (66 eyes) who developed POAG was compared with that of participants who did not develop POAG using multivariable mixed effects models.ResultsIn both univariate and multivariate analyses, the rate of rim area loss was significantly faster in eyes in which POAG developed than in eyes in which it did not (univariate mean, -0.0131 mm(2)/year and -0.0026 mm(2)/year, respectively). The significantly faster rate of rim area loss in black persons found in the univariate analysis did not remain significant when baseline disc area was included in the model. In multivariate analyses, the rate of rim area loss and other topographic parameters also was significantly faster in eyes with worse baseline visual field pattern standard deviation and higher intraocular pressure during follow-up. Moreover, a significant rate of rim area loss was detected in eyes in which POAG did not develop (P < .0001). The rate of rim area loss in eyes with an optic disc POAG endpoint was significantly faster than in those with a visual field POAG endpoint.ConclusionsThe rate of rim area loss is approximately 5 times faster in eyes in which POAG developed compared with eyes in which it did not. These results suggest that measuring the rate of structural change can provide important information for the clinical management of ocular hypertensive patients. Additional follow-up is needed to determine whether the statistically significant change in the eyes in which POAG did not develop represents normal aging or glaucomatous change not detected by conventional methods.

Project description:PurposeTo describe variability of intraocular pressure (IOP) measurements within the same eye and between right and left eyes over a 60-month period in participants in the Ocular Hypertension Treatment Study.DesignAnalysis of data from a prospective, randomized clinical trial.ParticipantsEight hundred ten participants randomized to the observation group.MethodsIntraocular pressure measurements were obtained at the baseline visit and every 6 months thereafter. Pearson correlation coefficients were calculated for IOP measurements in the same eye between visits and for IOP measurements between right and left eyes of participants at each visit. Differences in IOP measurements between visits are reported in percent change (>15%, >20%, and >30%) and in millimeters of mercury (<3 mmHg, 3-5 mmHg, and >5 mmHg). The effects of regression to the mean, consistency in time of day, and sequence of IOP measurement of right and left eyes were examined.Main outcome measuresCorrelation of IOP measurements between consecutive 6-month visits.ResultsThe correlation of IOP measurements within the same eye between consecutive visits was r = 0.62, whereas the correlation of IOP measurements between right and left eyes at the same visit was r = 0.72. Thirteen percent of eyes had >20% change in IOP between consecutive visits. Sixty-six percent of eyes had a change in IOP within 3 mmHg, and 10% of eyes had a change in IOP >5 mmHg between visits. Eyes with a higher baseline IOP had a lower IOP at 6 months. There was a stronger correlation of IOP measured within 2 hours of the time of day between visits (r = 0.56) than >2 hours apart (r = 0.39). IOP of the right eye, which was measured first, was 0.3+/-2.8 mmHg higher than the left eye.ConclusionsThe variability of IOP measurements in the same eye between consecutive visits is moderate and is greater than the variability of IOP measurements between right and left eyes at the same visit. Factors affecting the variability of IOP measurement include regression to the mean, time of day, and measurement order. Knowledge of variability in IOP and its measurements may help clinicians establish a more accurate baseline IOP, target IOP, and assessment of medication effect.

Project description:ImportanceTechniques that properly identify patients in whom ocular hypertension (OHTN) is likely to progress to open-angle glaucoma can assist clinicians with deciding on the frequency of monitoring and the potential benefit of early treatment.ObjectiveTo test whether Kalman filtering (KF), a machine learning technique, can accurately forecast mean deviation (MD), pattern standard deviation, and intraocular pressure values 5 years into the future for patients with OHTN.Design, setting, and participantsThis cohort study was a secondary analysis of data from patients with OHTN from the Ocular Hypertension Treatment Study, performed between February 1994 and March 2009. Patients underwent tonometry and perimetry every 6 months for up to 15 years. A KF (KF-OHTN) model was trained, validated, and tested to assess how well it could forecast MD, pattern standard deviation, and intraocular pressure at up to 5 years, and the forecasts were compared with results from the actual trial. Kalman filtering for OHTN was compared with a previously developed KF for patients with high-tension glaucoma (KF-HTG) and 3 traditional forecasting algorithms. Statistical analysis for the present study was performed between May 2018 and May 2019.Main outcomes and measuresPrediction error and root-mean-square error at 12, 24, 36, 48, and 60 months for MD, pattern standard deviation, and intraocular pressure.ResultsAmong 1407 eligible patients (2806 eyes), 809 (57.5%) were female and the mean (SD) age at baseline was 57.5 (9.6) years. For 2124 eyes with sufficient measurements, KF-OHTN forecast MD values 60 months into the future within 0.5 dB of the actual value for 696 eyes (32.8%), 1.0 dB for 1295 eyes (61.0%), and 2.5 dB for 1980 eyes (93.2%). Among the 5 forecasting algorithms tested, KF-OHTN achieved the lowest root-mean-square error (1.72 vs 1.85-4.28) for MD values 60 months into the future. For the subset of eyes that progressed to open-angle glaucoma, KF-OHTN and KF-HTG forecast MD values 60 months into the future within 1 dB of the actual value for 30 eyes (68.2%; 95% CI, 54.4%-82.0%) and achieved the lowest root-mean-square error among all models.Conclusions and relevanceThese findings suggest that machine learning algorithms such as KF can accurately forecast MD, pattern standard deviation, and intraocular pressure 5 years into the future for many patients with OHTN. These algorithms may aid clinicians in managing OHTN in their patients.

Project description:ImportanceAcetazolamide is commonly used to treat idiopathic intracranial hypertension (IIH), but there is insufficient information to establish an evidence base for its use.ObjectiveTo determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss.Design, setting, and participantsMulticenter, randomized, double-masked, placebo-controlled study of acetazolamide in 165 participants with IIH and mild visual loss who received a low-sodium weight-reduction diet. Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012 and followed up for 6 months (last visit in June 2013). All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation (PMD) between -2 dB and -7 dB. The mean age was 29 years and all but 4 participants were women.InterventionsLow-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide (up to 4 g/d) or matching placebo for 6 months.Main outcomes and measuresThe planned primary outcome variable was the change in PMD from baseline to month 6 in the most affected eye, as measured by Humphrey Field Analyzer. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss. Secondary outcome variables included changes in papilledema grade, quality of life (Visual Function Questionnaire 25 [VFQ-25] and 36-Item Short Form Health Survey), headache disability, and weight at month 6.ResultsThe mean improvement in PMD was greater with acetazolamide (1.43 dB, from -3.53 dB at baseline to -2.10 dB at month 6; n = 86) than with placebo (0.71 dB, from -3.53 dB to -2.82 dB; n = 79); the difference was 0.71 dB (95% CI, 0 to 1.43 dB; P = .050). Mean improvements in papilledema grade (acetazolamide: -1.31, from 2.76 to 1.45; placebo: -0.61, from 2.76 to 2.15; treatment effect, -0.70; 95% CI, -0.99 to -0.41; P < .001) and vision-related quality of life as measured by the National Eye Institute VFQ-25 (acetazolamide: 8.33, from 82.97 to 91.30; placebo: 1.98, from 82.97 to 84.95; treatment effect, 6.35; 95% CI, 2.22 to 10.47; P = .003) and its 10-item neuro-ophthalmic supplement (acetazolamide: 9.82, from 75.45 to 85.27; placebo: 1.59, from 75.45 to 77.04; treatment effect, 8.23; 95% CI, 3.89 to 12.56; P < .001) were also observed with acetazolamide. Participants assigned to acetazolamide also experienced a reduction in weight (acetazolamide: -7.50 kg, from 107.72 kg to 100.22 kg; placebo: -3.45 kg, from 107.72 kg to 104.27 kg; treatment effect, -4.05 kg, 95% CI, -6.27 to -1.83 kg; P < .001).Conclusions and relevanceIn patients with IIH and mild visual loss, the use of acetazolamide with a low-sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function. The clinical importance of this improvement remains to be determined.Trial registrationclinicaltrials.gov Identifier: NCT01003639.

Dataset Information

Effect of treatment on the rate of visual field change in the ocular hypertension treatment study observation group.

Publications

Effect of treatment on the rate of visual field change in the ocular hypertension treatment study observation group.

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