No financial interests to disclose Give Medications or Laser a Trial - - PowerPoint PPT Presentation

12/2/2016 1

Give Medications or Laser a Trial First

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

No financial interests to disclose

Arguments for giving medications or laser a trial first!

• Primum non nocere / first do no harm
• Cochrane review findings
• CIGTS
• Comparative effectiveness – U.S. Preventive

Services Task Force

• Surgery is higher risk in advanced glaucoma
• Patient trust
• New medication delivery systems

Primum non nocere

12/2/2016 2

Tubes are not without complications…

Primum non nocere

Meds: conjunctival hyperemia

• cular irritation

Laser: IOP spike mild inflammation Vision threatening: infection, bleeding, cataract, choroidals, hyphema, flat AC

Cochrane review: medical vs. surgical interventions for open angle glaucoma

• Updated in 2012
• Only 4 randomized controlled trial 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

12/2/2016 3

• 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)

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.”

12/2/2016 4

Arguments for giving medications or laser a trial first!

• Primum non nocere / first do no harm
• Cochrane review findings
• CIGTS
• Comparative effectiveness – U.S. Preventive

Services Task Force

• Surgery is higher risk in advanced glaucoma
• Patient trust
• New medication delivery systems

Medical vs. Surgical Interventions

• Incisional surgery lowers IOP more than laser
• r medications.low
• Initial treatment with lasers tends to reduce

the need for medications to achieve the same IOP.low

• Strong evidence from EMGT and OHTS that

medication treatment decreases risk of VF loss and progressive optic nerve damage.

www.effectivehealthcare.ahrq.gov/glaucomatreatment.cfm.

But really…insufficent evidence

• In four out of five trials, patients treated with
• lder medications had greater VF loss when

compared to those randomized to laser or trabeculectomy.

• Evidence was insufficient to distinguish a

difference in VF loss between surgical techniques and medications.

• For advanced glaucoma, evidence was

insufficient to guide clinical decision making regarding initial trabeculectomy or medication.

www.effectivehealthcare.ahrq.gov/glaucomatreatment.cfm.

12/2/2016 5

Comparative Adverse Effects

• Trabeculectomy is associated with cataract

worsening and increased need for cataract surgery when compared with medications.

• Intraocular surgery rarely results in severe

vision loss. However, these risks are not associated with medication or laser.

www.effectivehealthcare.ahrq.gov/glaucomatreatment.cfm.

Arguments for giving medications or laser a trial first!

• Primum non nocere / first do no harm
• Cochrane review findings
• CIGTS
• Comparative effectiveness – U.S. Preventive

Services Task Force

• Surgery is higher risk in advanced glaucoma
• Patient trust
• New medication delivery systems
• 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

• “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.”

12/2/2016 6 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)

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

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

Primum non nocere

• There is no harm in giving medications or laser 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”

• Stay tuned for new medication delivery systems that

may make improve medication adherence and effectiveness in the not-so-distant future!

12/2/2016 7

Thank you!

• “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.”

What about crossover?

• At 5 years, no statistically significant difference in the risk
• f failure of randomized treatment, defined as need to

crossover from medicine to surgery or vice-versa

Adverse events: CIGTS

• Mortality: With up to 9 years follow-up, 5% of medication

first patients died, whereas 9% of trabeculectomy first patients died

• Loss of an eye due to infection: Not reported
• Severe irreversible loss of vision: Not reported
• 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