Transcript Progression and follow-up intervals

Canadian Ophthalmological
Society
Evidence-based Clinical Practice
Guidelines for the Management of
Glaucoma in the Adult Eye
Progression
Definition of progression
• A patient’s glaucoma is deemed to have
progressed if structural and (or) functional
changes, associated with the disease, are
verifiably detected on clinical examination and
(or) testing.
• The clinical significance of this progression, and
the actions taken, will be influenced by:
– the extent of damage prior to the change, and
– the threat of visual handicap if further progression
were to occur.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Methods of detecting progression
• Progression may be detected, clinically or with
the aid of various technological investigations,
as loss of tissue (structural) and/or vision
(function).
• Careful ophthalmoscopy and precise
documentation (i.e., photography or imaging)
may confirm loss of RNFL or optic disc tissue
over time.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Methods of detecting
progression (cont’d)
• Confirming progressive vision loss requires
threshold evaluation of the peripheral field.
• In both instances, the potential for greater
sensitivity and quantification of change may
exist for technologically based evaluations
compared with clinical examinations alone.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Endpoints for conversion to, or
progression of, glaucoma in major RCTs
Study
Event measured
OHTS
Conversion to OAG
EGPS
CNTGS
EMGTS
Endpoints for event
measured in both
arms of study
ODP
VFP
ODP and VFP
Total
endpoints,
%
55
35
10
Conversion to OAG
ODP
VFP
40
60
Progression of OAG
ODP
VFP
11
89
Progression of OAG
ODP
VFP
ODP and VFP
1
86
13
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Progression — technology choices
Recommendation
Assessing disease severity is important to
determine which tests might be most useful for
each individual. Patients with glaucoma should be
monitored with both structural and functional tests,
as progression can be detected by either method
alone [Level 21].
1. Artes PH, et al. Prog Retin Eye Res
2005;24:333–54.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
VF progression endpoints for
the major glaucoma RCTs
RCT
VF endpoint
CNTGS
•
Deepening and (or) expansion of existing scotomas and (or)
new scotomas confirmed on 2 of 3, or 4 of 5 follow-up VFs
AGIS
•
Increase in VF score of 4 units on a scale of 0–20 from
2 baseline Humphrey 24-2 full-threshold VFs
CIGTS
•
Increase in VF score of 3 units on a scale of 0–20 (slightly
different from that used in AGIS) from baseline
EMGTS
•
Three adjacent points showing significant progression
according to the Humphrey Glaucoma Change Probability
assessment
CGS
•
Four of 8 points showed significant progression according to
the Humphrey Glaucoma Change Probability assessment on
2 of 3 VFs
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Advantages and disadvantages of
event-based and trend-based
approaches to VF progression
Type of progression
analysis
Event analysis
Advantages
Disadvantages
•
Earlier detection of
change
Fewer tests required
•
Rate of change (and
prognosis) possible
Allows clinician to
tailor aggressiveness
of therapy
More robust in the
face of intertest
variability
•
•
Trend analysis
•
•
•
•
•
Intertest variability may result
in change reverting to baseline
No rate of change calculation
possible
More tests and longer followup required
Insensitive to minor changes at
specific loci in the VF
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Progression — correlation
between structure and function
Recommendation
It is recommended that a correlation between
structural and functional changes be sought in
suspected progression, even though it is more
common for a change to be detected with one or
the other independently [Level 11-4].
1. Collaborative Normal-Tension Glaucoma Study Group.
Am J Ophthalmol 1998;126:487–97.
2. Kass MA, et al. Arch Ophthalmol 2002;120:701–13. Canadian Ophthalmological Society evidence-based clinical
3. Heijl A, et al. Arch Ophthalmol 2002;120:1268–79.
practice guidelines for the management of glaucoma in the
4. Miglior S, et al Ophthalmology 2002;109:1612–21.
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Risk factors and their relationship
to VF progression examined
in the landmark RCTs
Characteristic
CNTGS
CIGTS
EMGTS
AGIS
CGS
Age
No
Yes
Yes
Yes
Yes
Baseline IOP
No
NR
Yes
NR
No
Severity of VF
damage*
No
Yes
Yes
No
IOP over
follow-up
Intervisit IOP
fluctuation
Yes
No
Yes
Yes, but
opposite
direction
from other
trials
Yes
Yes
NR
NR
No
Yes†
No
*Positively associated if more severe baseline VF damage resulted in greater degree of VF progression
†Positive association in patients with low mean IOPs and not high mean IOPs
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Risk factors and their relationship
to VF progression examined
in the landmark RCTs
Characteristic
CNTGS
CIGTS
EMGTS
AGIS
CGS
Disc hemorrhage
Yes
NR
Yes
NR
NR
Migraine
Yes
NR
NR
NR
No
NonAsian
Female
Non-white
NR
No
NR
No
No
Male‡
Female
Pseudoexfoliation
NR
NR
Yes
NR
No
Diabetes
No
Yes
No
Yes
No
Anticardiolipin
antibody
NR
NR
NR
NR
Yes
Race
Gender
‡Positive
association in ATT and not TAT sequence
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Progression significant for
the patient
• The significance of a detectable structural and
(or) functional change would be different for
different patients.
• The ophthalmologist’s response should reflect
the significance to the patient.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Progression significant for
the patient (cont’d)
• Significance and action taken would be influenced by
some of the following considerations:
– What is the baseline level of glaucomatous damage (i.e., is the
VF full with a nearly normal-appearing disc, or is fixation
threatened in 3 of 4 quadrants)?
– What is the status of the fellow eye?
– What is the health of the patient and life expectancy?
– What are the visual demands of the patient (e.g., is he or she
still driving)?
– What is the next step? Is it heightened surveillance or is it
incisional surgery?
– What is the patient’s interpretation of the change and the
proposed actions?
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Visual field — progression confirmation
Recommendation
The clinician’s response to a new progressive
event should be to confirm the change with a
repeat test. VFs may need to be performed more
frequently during periods of apparent progression.
Ultimately, it is most important to calculate the rate
of progression over time [Consensus].
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Number of annual VF tests needed
to detect total mean deviation
change over 2, 3, and 5 years
Total mean deviation
change, dB
2 years
3 years
5 years
– 1.0
7
6
4
– 2.0
5
4
3
– 4.0
3
3
2
Adapted from: Chauhan BC, et al. Br J Ophthalmol 2008;92:569–73.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Visual field — baseline
Recommendation
In order to establish a good baseline and to detect
possible rapid progression, several VFs should be
performed at regular intervals in the first 2 years
[Consensus].
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Frequency of follow-up
• Frequency of follow-up is influenced by a number of
factors.
• Patients with stable glaucoma, or ocular hypertension
who are on treatment, need assessment at least once a
year.
• Depending on disease severity, other patients will
require more frequent assessments.
• Clinical judgment and common sense should be
exercised when dealing with very elderly patients who
travel long distances for follow-up, particularly during
the winter.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Recommended clinical assessment*
intervals for stable† chronic glaucomas
Stage
Interval
Glaucoma suspects
12 years
Early glaucoma
At least every 12 months
Moderate glaucoma
At least every 6 months
Advanced glaucoma‡
At least every 4 months
*Assessments
might include any of the components listed in Table 2 in addition to documentation of
the optic disc and VF testing.
†More frequent evaluations may be necessary if indications listed in Table 17 are noted.
‡It may be necessary to see patients with advanced glaucoma very frequently (weeks or days) if
their IOP is poorly controlled, progression appears rapid or fixation is threatened.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Indications for more frequent follow-up
or heightened surveillance
On the basis of the history
On the basis of the exam
Suspect adherence
Systemic drug change (new
corticosteroids or
antihypertensives)
Side effect to glaucoma
medication
Intervening eye infection
(especially for postoperative
eyes), trauma, surgery or iritis
Change in health status
IOP above target
Change in health insurance
(i.e., access to medications)
Change in social history
(i.e., availability of caregivers)
Disc change
VF change
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.
Progression: Treatment goals
• Some degree of progression may be
unavoidable in glaucoma.
• Goals for the clinician include:
– measuring and minimizing the progression,
– preserving or enhancing QOL, and
– choosing a management scheme that is
appropriate and acceptable to the patient.
Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the
adult eye. Can J Ophthalmol 2009;44(Suppl 1):S1S93.