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 StudyEvent measuredEndpoints for event measured in both arms of study Total endpoints, % OHTSConversion to OAG ODP VFP ODP and VFP EGPSConversion to OAG ODP VFP CNTGSProgression of OAG ODP VFP EMGTSProgression of OAG ODP VFP ODP and VFP 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 2 1 ]. 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 RCTVF endpoint CNTGSDeepening and (or) expansion of existing scotomas and (or) new scotomas confirmed on 2 of 3, or 4 of 5 follow-up VFs AGISIncrease in VF score of 4 units on a scale of 0–20 from 2 baseline Humphrey 24-2 full-threshold VFs CIGTSIncrease in VF score of 3 units on a scale of 0–20 (slightly different from that used in AGIS) from baseline EMGTSThree adjacent points showing significant progression according to the Humphrey Glaucoma Change Probability assessment CGSFour 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 AdvantagesDisadvantages Event analysisEarlier detection of change Fewer tests required Intertest variability may result in change reverting to baseline No rate of change calculation possible Trend analysisRate of change (and prognosis) possible Allows clinician to tailor aggressiveness of therapy More robust in the face of intertest variability More tests and longer follow- up 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 ]. 1. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol 1998;126:487– Kass MA, et al. Arch Ophthalmol 2002;120:701– Heijl A, et al. Arch Ophthalmol 2002;120:1268– Miglior S, et al Ophthalmology 2002;109:1612–21. 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 CharacteristicCNTGSCIGTSEMGTSAGISCGS AgeNoYes Baseline IOPNoNRYesNRNo Severity of VF damage* NoYes Yes, but opposite direction from other trials No IOP over follow-up YesNoYes Intervisit IOP fluctuation NR NoYes † 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 CharacteristicCNTGSCIGTSEMGTSAGISCGS Disc hemorrhageYesNRYesNR MigraineYesNR No RaceNon- Asian Non-whiteNRNoNR GenderFemaleNo Male ‡ Female PseudoexfoliationNR YesNRNo DiabetesNoYesNoYesNo Anticardiolipin antibody NR Yes ‡ 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 years3 years5 years – – – 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 StageInterval Glaucoma suspects 1  2 years Early glaucomaAt least every 12 months Moderate glaucomaAt 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 historyOn the basis of the exam Suspect adherenceSide effect to glaucoma medication Systemic drug change (new corticosteroids or antihypertensives) Intervening eye infection (especially for postoperative eyes), trauma, surgery or iritis Change in health statusIOP above target Change in health insurance (i.e., access to medications) Disc change Change in social history (i.e., availability of caregivers) 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.