Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: quality-of-life findings: SST report no. 12.
OBJECTIVE
To describe health-related quality of life (HRQOL), overall and in patients with unilateral or bilateral choroidal neovascularization (CNV), in a clinical trial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age-related macular degeneration (AMD).


METHODS
Randomized clinical trial.


METHODS
Eligible patients had untreated subfoveal CNV and AMD, best-corrected visual acuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a total subfoveal lesion size of < or =9.0 disc areas in the study eye.


METHODS
Health-related quality of life data (the National Eye Institute Visual Function Questionnaire [NEI-VFQ], 36-item Short Form Health Survey [SF-36], and Hospital Anxiety and Depression Scale [HADS]) and clinical data were collected at baseline and at 6, 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence.


METHODS
Two-year change in the NEI-VFQ.


RESULTS
Of 454 patients enrolled, 228 were assigned to observation and 226 to surgery. At baseline, median overall NEI-VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation group had lost a median of 3 points (95% confidence interval [CI]: -6 to -2), and the surgery group gained a median of 1 point (CI: -1 to 3). The largest difference was observed for the mental health subscale, where the observation group lost a median of 5 points (CI: -5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2-year changes in NEI-VFQ scores favored surgery by up to 10 points for unilateral cases and up to 8 points for bilateral cases. No treatment difference in 2-year change was observed for the SF-36 physical component summary; 2-year change in the mental component summary favored surgery by 2 points. Few patients (2%-4%) had HADS definite anxiety or depression at baseline or at 24 months.


CONCLUSIONS
Although HRQOL outcomes were better in the submacular surgery arm than in the observation arm, surgery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.
Miskala
Päivi H
PH
SST Coordinating Center, 550 North Broadway, 9th Floor, Baltimore, MD 21205-2010, USA.
Bass
Eric B
EB
Bressler
Neil M
NM
Childs
Ashley L
AL
Hawkins
Barbara S
BS
Mangione
Carol M
CM
Marsh
Marta J
MJ
D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000523:psychology* / Q000601:surgery*; D005260:Female; D005451:Fluorescein Angiography; D005584:Fovea Centralis / Q000601:surgery*; D006304:Health Status; D006801:Humans; D008268:Macular Degeneration / Q000523:psychology* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D011788:Quality of Life; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires; D014481:United States; D014792:Visual Acuity / Q000502:physiology