PURPOSE: Higher baseline pattern standard deviation (PSD) and larger vertical cup-to-disk ratio (VC/D) were factors in the predictive model for the development of primary open-angle glaucoma (POAG) in the Ocular Hypertension Treatment Study. Because early changes in PSD and VC/D may be indicative of early POAG damage, we repeated the prediction model excluding PSD and VC/D.DESIGN: Reanalysis of baseline factors for the development of POAG.METHODS: We compared the hazard ratios for baseline factors predictive of POAG in the multivariate Cox proportional hazards model that included PSD and VC/D and in the model that excluded them.RESULTS: Hazard ratios for baseline factors predictive of POAG in Ocular Hypertension Treatment Study were not substantially affected by the inclusion or exclusion of PSD and VC/D in the proportional hazards model.CONCLUSION: Whether PSD or VC/D was included in the Cox proportional hazards model, the same baseline factors were statistically significant and their hazard ratios were essentially similar. (C) 2004 by Elsevier Inc. All rights reserved.
OBJECTIVETo compare the intraocular pressure (IOP) responses of self-identified African American and white participants in the Ocular Hypertension Treatment Study to therapeutic trials of topical, nonselective beta-adrenergic antagonists or prostaglandin analogues.METHODSMultivariate models that adjusted for baseline IOP and corneal thickness were used to estimate IOP response by race. Participants included 536 who were prescribed topical beta-adrenergic antagonists and 191 who were prescribed prostaglandin analogues, 25% of whom were African American.MAIN OUTCOME MEASUREIntraocular pressure response in the ipsilateral eye after 4 to 6 weeks of a therapeutic trial.RESULTSIntraocular pressure response to nonselective beta-adrenergic antagonists did not differ between African American and white participants. Intraocular pressure response to prostaglandin analogues was slightly greater in African American participants, but this difference was not statistically significant. With both classes of medication, greater IOP reduction was associated with higher baseline IOP and thinner central corneal measurement.CONCLUSIONSWe found no statistically significant differences in IOP response to topical, nonselective beta-adrenergic antagonists or prostaglandin analogues between self-identified African American and white individuals. Application to Clinical Practice Studies of IOP response to medication should statistically adjust for baseline IOP and central corneal thickness. Clinicians should consider factors other than ethnicity when choosing an ocular hypotensive medication for a patient.TRIAL REGISTRATIONclinicaltrials.gov Identifier: NCT00000125.
OBJECTIVE To determine whether baseline confocal scanning laser ophthalmoscopy (CSLO) optic disc topographic measurements are associated with the development of primary open-angle glaucoma (POAG) in individuals with ocular hypertension. METHODS Eight hundred sixty-five eyes from 438 participants in the CSLO Ancillary Study to the Ocular Hypertension Treatment Study with good-quality baseline CSLO images were included in this study. Each baseline CSLO parameter was assessed in univariate and multivariate proportional hazards models to determine its association with the development of POAG. RESULTS Forty-one eyes from 36 CSLO Ancillary Study participants developed POAG. Several baseline topographic optic disc measurements were significantly associated with the development of POAG in both univariate and multivariate analyses, including larger cup-disc area ratio, mean cup depth, mean height contour, cup volume, reference plane height, and smaller rim area, rim area to disc area, and rim volume. In addition, classification as "outside normal limits" by the Heidelberg Retina Tomograph classification and the Moorfields Regression Analysis classifications (overall, global, temporal inferior, nasal inferior, and superior temporal regions) was significantly associated with the development of POAG. Within the follow-up period of this analysis, the positive predictive value of CSLO indexes ranged from 14% (Heidelberg Retina Tomograph classification and Moorfields Regression Analysis overall classification) to 40% for Moorfields Regression Analysis temporal superior classification. CONCLUSIONS Several baseline topographic optic disc measurements alone or when combined with baseline clinical and demographic factors were significantly associated with the development of POAG among Ocular Hypertension Treatment Study participants. Longer follow-up is required to evaluate the true predictive accuracy of CSLO measures.
BACKGROUNDThe prevalence of glaucoma is higher in African American individuals than in white individuals.OBJECTIVETo report the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of primary open-angle glaucoma (POAG) among African American participants in the Ocular Hypertension Treatment Study.METHODSEligibility criteria included age between 40 and 80 years, intraocular pressure between 24 and 32 mm Hg in one eye and between 21 and 32 mm Hg in the other eye, and no evidence of glaucomatous structural or functional damage by standard clinical measures. Participants were randomized to either the observation group or medication group. Of the 1636 participants randomized, 408 were self-identified as African American.MAIN OUTCOME MEASUREThe primary outcome was the development of reproducible visual field abnormality and/or reproducible optic disc deterioration attributed to POAG.RESULTSAmong African American participants, 17 (8.4%) of 203 in the medication group developed POAG during the study (median follow-up, 78 months) compared with 33 (16.1%) of 205 participants in the observation group (hazard ratio, 0.50; 95% confidence interval, 0.28-0.90; P =.02).CONCLUSIONTopical ocular hypotensive therapy is effective in delaying or preventing the onset of POAG in African American individuals who have ocular hypertension.
PURPOSE: To determine whether central corneal thickness (CCT) correlates with measured intraocular pressure (IOP) response to topical ocular hypotensive medication in the Ocular Hypertension Treatment Study (OHTS).DESIGN: Prospective randomized clinical trial.METHODS: Intraocular pressure measurements were performed by Goldmann applanation tonometry. Central corneal thickness was measured by ultrasonic pachymetry. The following indicators of IOP response to topical ocular hypotensive medication were examined: (1) IOP after an initial four- to six-week one-eyed therapeutic trial of a nonselective beta-blocker (N = 549) or a prostaglandin analog (N = 201); (2) the mean IOP response during, 12 to 60 months of follow-up among medication participants (N = 689); (3) the percentage of follow-up visits at which both eyes met the treatment goal; (4). the total number of different medications prescribed to reach treatment goal; and (5) the total number of different medications prescribed multiplied by the number of months each medication was prescribed.RESULTS: Central corneal thickness was inversely related to the IOP response after the initial one,eyed therapeutic trial and during 12 to 60 months of follow-up (P < .05). Mean CCT was not correlated with the number of different medications prescribed during follow-up, the total medication,months, or the percentage of visits at which IOP target was met. CONCLUSIONS: Individuals with thicker corneas had smaller measured IOP responses to ocular hypotensive medication than those with normal or thin corneas. We believe that CCT measurements may be useful in patient management and in interpreting clinical trials of ocular hypotensive medication. (C) 2004 by Elsevier Inc. All rights reserved.
BACKGROUND:The Ocular Hypertension Treatment Study (OHTS) has shown that topical ocular hypotensive medication is effective in delaying or preventing the onset of primary open-angle glaucoma (POAG) in individuals with elevated intraocular pressure (ocular hypertension) and no evidence of glaucomatous damage.OBJECTIVE:To describe baseline demographic and clinical factors that predict which participants in the OHTS developed POAG.METHODS:Baseline demographic and clinical data were collected prior to randomization except for corneal thickness measurements, which were performed during follow-up. Proportional hazards models were used to identify factors that predicted which participants in the OHTS developed POAG.RESULTS:In univariate analyses, baseline factors that predicted the development of POAG included older age, race (African American), sex (male), larger vertical cup-disc ratio, larger horizontal cup-disc ratio, higher intraocular pressure, greater Humphrey visual field pattern standard deviation, heart disease, and thinner central corneal measurement. In multivariate analyses, baseline factors that predicted the development of POAG included older age, larger vertical or horizontal cup-disc ratio, higher intraocular pressure, greater pattern standard deviation, and thinner central corneal measurement.CONCLUSIONS:Baseline age, vertical and horizontal cup-disc ratio, pattern standard deviation, and intraocular pressure were good predictors for the onset of POAG in the OHTS. Central corneal thickness was found to be a powerful predictor for the development of POAG.
OBJECTIVE:To determine the effect of combined finasteride and flutamide therapy on haemoglobin and haematocrit values in men with advanced prostate cancer. PATIENTS AND METHODS:Nineteen men, previously untreated by hormone therapy, with histologically confirmed adenocarcinoma of the prostate and clinical evidence of advanced disease, were treated with combined finasteride (5 mg/day) and flutamide (750 mg/day) for at least 6 months. Complete blood counts were performed before initiation and after 6 months of therapy. RESULTS:After 6 months of finasteride and flutamide therapy both haemoglobin levels and haematocrit decreased in all men, with a mean (sd, range) decrease of 16 (10, 3-42) g/L and 4.6 (2.7, 0.8-9.9)%, respectively. CONCLUSION:Combined finasteride and flutamide therapy significantly lowers haemoglobin and haematocrit levels in men with advanced prostate cancer, and further study of this effect is warranted.