No financial interests to disclose Yvonne Ou, MD Assistant - - PowerPoint PPT Presentation

12/4/2015 1

Management of Newly Diagnosed Advanced Glaucoma: Medications or Surgery?

Yvonne Ou, MD Assistant Professor of Ophthalmology University of California, San Francisco

No financial interests to disclose

Patient with newly diagnosed glaucoma

• Referred by optometrist
• IOP = 38 and 36 mmHg
• Nerves: inferior notches

and severe superior thinning OD worse than OS 69-year-old retiree

12/4/2015 2

Would you start medications first or go straight to surgery?

• A: Medications
• B: Surgery

Arguments for giving medications a trial first!

• Primum non nocere / first do no harm
• Cochrane review findings
• CIGTS
• Surgery is higher risk in advanced glaucoma
• Patient trust

Primum non nocere Tubes are not without complications…

12/4/2015 3 Cochrane review: medical vs. surgical interventions for open angle glaucoma

• Updated in 2012
• Only 4 randomized controlled trials met review inclusion

– Glasgow trial – Moorfields GT – Moorfields PTT – CIGTS

• These trials were done in an era before PGAs were

available

• Because the UK studies used pilocarpine for medical

treatment, we will focus on CIGTS

Visual acuity

• At 5 years, initial medical treatment was associated

with half the risk of a VA loss of ~2 lines of Snellen acuity, adjusting for age, race, diabetes, time in study, cataract surgery

Ophthalmology 2001;108:1943-1953

• Visual field outcomes

– At 5 years (~88% of participants), no difference in MD scores between groups – At 8 years (~50% of participants), no difference in MD scores between groups

Ophthalmology 2009;116:200-207

• What about patients with severe glaucoma (MD -

10 dB)?

– Surgical patients had marginally better VF scores than those treated medically (mean difference of 0.74 dB)

• What about African American patients?

– African Americans who required cataract surgery during follow-up had more VF loss

• What about diabetic patients?

– Diabetic patients had worse progression on VF when treated surgically (2.65 dB worse) than medically (1.89 dB worse)

12/4/2015 4

Adverse events

• Visually significant cataract: at 3 years, trabeculectomy

patients had 3 times the risk of requiring cataract surgery; at 5 years, there was 4 times the risk; beyond 5 years, no difference

• Surgical complications:

– 14% shallow or flat AC – 12% encapsulated blebs – 12% ptosis – 11% serous choroidal detachment – 10% hyphema

• “Further RCTs of current medical treatments compared

to surgery are required, particularly for people with severe glaucoma and in black ethnic groups.”

Arguments for giving medications a trial first!

• Primum non nocere / first do no harm
• Cochrane review findings
• CIGTS
• Surgery is higher risk in advanced glaucoma
• Patient trust
• 56.5% patients had transient vision loss

– Mean time to recovery was 78-88 days

• 8% patients had permanent vision loss

– Risk factors for severe permanent vision loss include:

• Preoperative split fixation
• Number of quadrants with split fixation
• Choroidal effusion with eventual resolution

Arch Ophthalmol. 2011;129(8):1011-1017

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• “In conclusion, our findings suggest that

unexplained vision loss (or snuff-out) occurs after trabeculectomy with mitomycin C treatment. Risk factors for long-term vision loss are preoperative split fixation on VFs, preoperative number of quadrants with split fixation, and postoperative choroidal effusions with eventual resolution. Transient vision loss is common and may take up to 2 years for recovery.”

Patient-physician trust improves adherence and decreases anxiety about surgery

• Self-reported adherence to physician’s advice

and patient satisfaction increased with patient trust (Safran DG et al. J Fam Pract. 1998;47:213-20)

• Patient’s preoperative anxiety about filtration

surgery is reduced when patients trust their surgeon (Lemaitre S et al. J Fr Ophthalmol. 2014;37:47-53)

Arguments for going straight to surgery

• What does Europe do?
• Degree of damage / target IOP
• Fast progressor
• Medication compliance is poor

Initial Surgery for Patients Presenting with Advanced Glaucoma

• National Institute for Health and Care Excellence

(NICE) in the UK

• Recommends offering initial surgery to patients

presenting with advanced glaucoma

12/4/2015 6

Degree of damage / Target IOP

• The worse the damage, the lower the target IOP
• 50% IOP reduction or more
• CIGTS: required 37% of IOP reduction for no

progression

• AGIS: only the lowest IOP group (mean = 12

mmHg) no progression

• Initial extent of VF loss is greatest predictor of

further VF loss

Fast Progressor

• African American
• Young age (relatively)
• Split fixation at presentation with severe optic

nerve damage

Poor compliance and adherence

• Multiple medications leads to non-adherence
• Even adherent patients may have allergy or poor

efficacy

• Leads to delay in IOP control
• Leads to progression and blindness

Primum non nocere: Meds first!

• There is no harm in giving medications a TRIAL first
• If they fail, you have not done any irreversible

damage and can move quickly onto surgical options

• Surgery is higher risk in advanced glaucoma

patients and can lead to ”snuff out”

• Patient’s knowledge about glaucoma and trust in

MD decision making and skill increases with time, which leads to better outcomes including self- reported adherence with treatment plan, satisfaction with physician, and less anxiety

12/4/2015 7

Primum non nocere: Surgery first!

• There may be harm in delaying ultimate IOP control
• Patients have difficulties with medication compliance

and adherence

• It is often difficult to achieve target IOPs in patients

with advanced glaucoma using medications alone

• CIGTS did show that patients with advanced

glaucoma who had immediate surgery had better VF

• utcomes than patients who went on medications

Management of Newly Diagnosed Advanced Glaucoma: Medications or Surgery?

Thank you!

New medication delivery systems will improve adherence

• Injectable formulations such as microspheres,

liposomes, nanoparticles

• Subconjunctival injections
• Conjunctival inserts
• Sub-Tenon’s injections
• Intravitreal inserts
• Punctal plugs
• Contact lenses

12/4/2015 8

CIGTS: Health-related quality of life

• No statistically significant difference on total score for

visual activities questionnaire

• On the Symptom Impact Glaucoma Scale, patients

undergoing trabeculectomy reported 22.3% more symptoms on the total score (p = 0.005) and 20.2% more symptoms on the local eye symptom subscale (p = 0.03)

One can achieve target IOPs with medications

• In CIGTS at 5 years, no statistically significant difference

in the risk of failure of randomized treatment, defined as need to crossover from medicine to surgery or vice-versa

The “perfect” glaucoma surgery does not yet exist

• Effective

– As or more effective than drops or laser – Lowers IOP enough to prevent further damage but not too low

• Safe both intra- and post-operatively
• Relatively easy to perform
• Burns no bridges
• Repeatable
• ? In-office procedure
• Cost effective
• “Among the implications of these results to clinical

practice, perhaps the most important is the limited amount of VF loss that occurred over extended follow-up. The authors attribute this to the attention paid in the CIGTS to IOP control, which likely was much stricter than what occurs in the community. The VF

• utcomes for those with more advanced VF loss at

baseline, in whom surgery was advantageous, and the

• utcomes for diabetics, in whom surgery was

disadvantageous, are important.”