Objective: A recently reported randomized study described the role of intra
ocular pressure (IOP) in normal-tension glaucoma (NTG) pathogenesis and the
effect of therapeutic lowering of IOP. This is a report of an analysis of
the natural course of NTG during the time eyes were not receiving therapy,
either in the time interval awaiting randomization or after being randomly
assigned not to receive treatment to lower the IOP.
Design: Analysis of prospectively collected data on the long-term course of
a cohort of untreated subjects with normal-tension glaucoma, a subset of s
ubjects enrolled in a randomized controlled clinical trial.
Randomization and Subject Selection: If the field defect in the study eye t
hreatened the point of fixation, the subject was randomly assigned to start
on treatment immediately or to be observed without treatment until progres
sion was documented. Otherwise, an eye was randomly assigned only when and
if, subsequent to enrollment, it showed visual field progression, progressi
on of optic disc cupping, or a new disc hemorrhage.
Participants: Data were collected for this report on 160 subjects observed
without treatment among a total enrollment of 260, They consist of 49 subje
cts who were randomly assigned on enrollment not to receive therapy, 24 fol
lowed without treatment for a time until later being randomly assigned to t
reatment, 31 similarly followed without treatment and who were later random
ly assigned to be followed for an additional time without treatment, and 56
who enrolled but were never randomly assigned.
Main Outcome Measures: Visual field data were used in this report only from
the interval during which the eye had not been assigned to receive therapy
and were analyzed by two measures of progression: the "survival" time to m
eeting a criterion of confirmed localized progression and the rate of chang
e in the mean deviation (MD) index over time.
Results: The four subgroups just described were similar at baseline, except
that the average MD index was slightly better for the 56 eyes that never p
rogressed during the period of follow-up. By Kaplan-Meier analysis of all u
ntreated subjects combined, approximately one third showed localized progre
ssion within 3 years and about half within 5 to 7 years. Of subjects follow
ed for 3 years or more, 62 of 109 did not show a statistically significant
negative slope of MD regressed over time, whereas the others showed a stati
stically significant MD decline, mainly between -0.2 and -2 db per year.
Conclusions: Some cases of NTG progress more rapidly than others. Although
approximately half of cases showed a confirmed localized visual field deter
ioration by 7 years, the change is typically small and slow, often insuffic
ient to measurably affect the MD index. Ophthalmology 2001;108:247-253 (C)
2001 by the American Academy of Ophthalmology.