Treatment and Vision-Related Quality of Life in the Early Manifest Glaucoma Trial

Purpose To evaluate the effect of treatment, visual function, and other factors on vision-targeted health-related quality of life (HRQOL) of patients with early glaucoma. Design Randomized clinical trial. Participants Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field (VF) defects, 50 to 80 years old (66% female). Methods Patients were randomized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s) or no initial treatment and had ophthalmologic examinations every 3 months. A Swedish translation of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was self-administered at 2 follow-up visits (3 and 6 years after randomization). Main Outcome Multiple linear regression analyses determined the effect of treatment and other factors on (1) VFQ-25 composite scores at the first administration and (2) change in scores between administrations. Results Two hundred thirty-three patients had 1 NEI VFQ-25 administration and 167 patients had 2 administrations. Internal consistency reliability was high for the composite VFQ-25 score (Cronbach α = 0.88) and satisfactory (α≥0.76) for most subscale scores. At the first administration, the composite score was high (88.8±11.7). Mean subscale scores were also generally high (98.0–58.3) and were similar for each study group when analyzed separately. Most lower subscale scores were modestly but significantly related to worse visual acuity (VA) or mean deviation (MD) (better eye, r = 0.15–0.35). Composite scores were similar for treated and untreated patients. Lower composite scores were associated with low VA in the better eye (worse than 0.70) and worse perimetric MD (<4.16 decibels) and nuclear lens opacities (Lens Opacities Classification System II grade ≥ 2), but not with age, gender, VF progression, intraocular pressure, cardiovascular disease, or hypertension. Between VFQ-25 administrations, larger decreases in the composite score were associated with larger decreases in VA (P<0.05), female gender (P = 0.001), and older age at first administration (P = 0.006). Treatment (assigned at randomization or later in the study) was not associated with change in HRQOL. Conclusions Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients. However, visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment. To evaluate the effect of treatment, visual function, and other factors on vision-targeted health-related quality of life (HRQOL) of patients with early glaucoma. Randomized clinical trial. Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field (VF) defects, 50 to 80 years old (66% female). Patients were randomized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s) or no initial treatment and had ophthalmologic examinations every 3 months. A Swedish translation of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was self-administered at 2 follow-up visits (3 and 6 years after randomization). Multiple linear regression analyses determined the effect of treatment and other factors on (1) VFQ-25 composite scores at the first administration and (2) change in scores between administrations. Two hundred thirty-three patients had 1 NEI VFQ-25 administration and 167 patients had 2 administrations. Internal consistency reliability was high for the composite VFQ-25 score (Cronbach α = 0.88) and satisfactory (α≥0.76) for most subscale scores. At the first administration, the composite score was high (88.8±11.7). Mean subscale scores were also generally high (98.0–58.3) and were similar for each study group when analyzed separately. Most lower subscale scores were modestly but significantly related to worse visual acuity (VA) or mean deviation (MD) (better eye, r = 0.15–0.35). Composite scores were similar for treated and untreated patients. Lower composite scores were associated with low VA in the better eye (worse than 0.70) and worse perimetric MD (<4.16 decibels) and nuclear lens opacities (Lens Opacities Classification System II grade ≥ 2), but not with age, gender, VF progression, intraocular pressure, cardiovascular disease, or hypertension. Between VFQ-25 administrations, larger decreases in the composite score were associated with larger decreases in VA (P<0.05), female gender (P = 0.001), and older age at first administration (P = 0.006). Treatment (assigned at randomization or later in the study) was not associated with change in HRQOL. Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients. However, visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment.