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

12/2/2016 No financial interests to disclose Give Medications or Laser a Trial First Yvonne Ou, MD Assistant Professor of Ophthalmology University of California, San Francisco Arguments for giving medications or Primum non nocere 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 1

12/2/2016 Tubes are not without Primum non nocere complications… Meds: conjunctival hyperemia ocular irritation Vision threatening: Laser: IOP spike infection, bleeding, mild inflammation 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 Visual acuity – Moorfields PTT • At 5 years, initial medical treatment was associated – CIGTS with half the risk of a VA loss of ~2 lines of Snellen acuity, adjusting for age, race, diabetes, time in study, • These trials were done in an era before PGAs were cataract surgery available • Because the UK studies used pilocarpine for medical treatment, we will focus on CIGTS Ophthalmol ogy 2001;108:1943-1953 2

12/2/2016 • 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) • Visual field outcomes • What about African American patients? – At 5 years (~88% of participants), no difference in MD scores between groups – African Americans who required cataract surgery – At 8 years (~50% of participants), no difference in MD during follow-up had more VF loss scores between groups • What about diabetic patients? – Diabetic patients had worse progression on VF when treated surgically (2.65 dB worse) than medically (1.89 dB worse) Ophthalmol ogy 2009;116:200-207 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.” 3

12/2/2016 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 But really…insufficent evidence Medical vs. Surgical Interventions • In four out of five trials, patients treated with • Incisional surgery lowers IOP more than laser older medications had greater VF loss when or medications. low compared to those randomized to laser or • Initial treatment with lasers tends to reduce trabeculectomy. • Evidence was insufficient to distinguish a the need for medications to achieve the same IOP. low difference in VF loss between surgical • Strong evidence from EMGT and OHTS that techniques and medications. • For advanced glaucoma, evidence was medication treatment decreases risk of VF loss and progressive optic nerve damage. insufficient to guide clinical decision making regarding initial trabeculectomy or www.effectivehealthcare.ahrq.gov/glaucomatreatment.cfm. www.effectivehealthcare.ahrq.gov/glaucomatreatment.cfm. medication. 4

12/2/2016 Arguments for giving medications or Comparative Adverse Effects laser a trial first! • Trabeculectomy is associated with cataract • Primum non nocere / first do no harm worsening and increased need for cataract • Cochrane review findings surgery when compared with medications. • CIGTS • Comparative effectiveness – U.S. Preventive • Intraocular surgery rarely results in severe Services Task Force • Surgery is higher risk in advanced glaucoma vision loss. However, these risks are not • Patient trust associated with medication or laser. • New medication delivery systems www.effectivehealthcare.ahrq.gov/glaucomatreatment.cfm. 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 • 56.5% patients had transient vision loss eventual resolution. Transient vision loss is common and may take up to 2 years for recovery.” – 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 5

12/2/2016 New medication delivery systems will Patient-physician trust improves adherence and decreases anxiety about surgery improve adherence • Self-reported adherence to physician’s advice • Injectable formulations such as microspheres, liposomes, nanoparticles and patient satisfaction increased with patient trust (Safran DG et al. J Fam Pract . 1998;47:213-20) • Subconjunctival injections • Conjunctival inserts • Patient’s preoperative anxiety about filtration • Sub-Tenon’s injections surgery is reduced when patients trust their • Intravitreal inserts surgeon (Lemaitre S et al. J Fr Ophthalmol . 2014;37:47-53) • Punctal plugs • Contact lenses Primum non nocere The “perfect” glaucoma surgery • There is no harm in giving medications or laser a does not yet exist TRIAL first • Effective – As or more effective than drops or laser • If they fail, you have not done any irreversible – Lowers IOP enough to prevent further damage but not too low damage and can move quickly onto surgical options • Safe both intra- and post-operatively • Relatively easy to perform • Surgery is higher risk in advanced glaucoma patients and can lead to ”snuff out” • Burns no bridges • Repeatable • Stay tuned for new medication delivery systems that • ? In-office procedure may make improve medication adherence and effectiveness in the not-so-distant future! • Cost effective 6

12/2/2016 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 outcomes for those with more advanced VF loss at baseline, in whom surgery was advantageous, and the outcomes for diabetics, in whom surgery was disadvantageous, are important.” Adverse events: CIGTS What about crossover? • Mortality: With up to 9 years follow-up, 5% of medication first patients died, whereas 9% of trabeculectomy first • At 5 years, no statistically significant difference in the risk patients died of failure of randomized treatment, defined as need to • Loss of an eye due to infection: Not reported crossover from medicine to surgery or vice-versa • 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 7