Abstract
Purpose: :
To evaluate differences in characteristics of clinical trial participants with newly-diagnosed primary (POAG), pseudoexfoliative (PEX), and pigmentary (PGM) forms of open-angle glaucoma (OAG).
Methods: :
607 subjects with newly-diagnosed OAG were enrolled in the Collaborative Initial Glaucoma Treatment Study (CIGTS) between October, 1993 and April, 1997. Three types of open-angle glaucoma were included: POAG, PEX, and PGM. A thorough baseline examination was performed. Clinical measures included the mean deviation (MD) from Humphrey 24-2 full threshold visual field testing, refraction and best-corrected visual acuity measured using the ETDRS protocol, and IOP determination by Goldmann applanation tonometry. Comparisons were performed using analysis of variance, chi-square tests, extended Fisher’s exact tests, and multinomial logistic regression.
Results: :
Of 607 enrollees, 550 (91%) were diagnosed with POAG, 29 (5%) with PEX, and 28 (5%) with PGM. Age at diagnosis differed significantly (p<0.0001); enrollees with PEX were older (65 yrs) than those with POAG (58 yrs) or PGM (49 yrs). IOP at enrollment was significantly higher (p<0.0001) in those with PEX (32 mmHg) vs. POAG or PGM (27 & 28 mmHg, respectively). Enrollees with PGM were more likely to have high myopia (≤-6D SphEq): 29% PGM vs. 5% POAG and 4% PEX. In terms of race, family history of glaucoma, and diabetes, enrollees with POAG were more likely to be blacks (41% POAG vs. 3% PEX and 7% PGM; p<0.0001), more likely to have a positive family history (39% POAG vs. 27% PEX and 8% PGM; p=0.0016), and more likely to have diabetes (18% POAG vs. 4% PEX and 4% PGM; p=0.0136).
Conclusions: :
Newly diagnosed enrollees into a clinical trial of OAG treatment differed relative to the type of OAG. Enrollees with PEX were older and had higher IOP. Those with POAG were more likely to be blacks, have a family history of glaucoma, and be diabetic. PGM enrollees were younger and more likely to have high myopia. Some of these differences relate to the underlying pathogenesis of the specific type of OAG; others are noteworthy for confirmation and further investigation.
Clinical Trial: :
www.clinicaltrials.gov NCT00000149
Keywords: clinical (human) or epidemiologic studies: prevalence/incidence • clinical (human) or epidemiologic studies: risk factor assessment