12/4/2015 Management of Newly Diagnosed Advanced Glaucoma: Medications or Surgery? No financial interests to disclose Yvonne Ou, MD Assistant Professor of Ophthalmology University of California, San Francisco 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 1
12/4/2015 Would you start medications first or go Arguments for giving medications a trial first! straight to surgery? • Primum non nocere / first do no harm • A: Medications • B: Surgery • Cochrane review findings • CIGTS • Surgery is higher risk in advanced glaucoma • Patient trust Tubes are not without Primum non nocere complications… 2
12/4/2015 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 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 • 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 3
12/4/2015 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! Arch Ophthalmol . 2011;129(8):1011-1017 • 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 4
12/4/2015 Patient-physician trust improves adherence and decreases anxiety about surgery • “ In conclusion, our findings suggest that • Self-reported adherence to physician’s advice unexplained vision loss (or snuff-out) occurs after and patient satisfaction increased with patient trabeculectomy with mitomycin C treatment . Risk trust (Safran DG et al. J Fam Pract . 1998;47:213-20) factors for long-term vision loss are preoperative split fixation on VFs, preoperative number of quadrants with split fixation, and postoperative choroidal effusions with • Patient’s preoperative anxiety about filtration eventual resolution. Transient vision loss is common and surgery is reduced when patients trust their may take up to 2 years for recovery.” surgeon (Lemaitre S et al. J Fr Ophthalmol . 2014;37:47-53) Initial Surgery for Patients Presenting Arguments for going straight to surgery with Advanced Glaucoma • What does Europe do? • National Institute for Health and Care Excellence (NICE) in the UK • Degree of damage / target IOP • Fast progressor • Recommends offering initial surgery to patients • Medication compliance is poor presenting with advanced glaucoma 5
12/4/2015 Degree of damage / Target IOP Fast Progressor • The worse the damage, the lower the target IOP • African American • 50% IOP reduction or more • Young age (relatively) • CIGTS: required 37% of IOP reduction for no • Split fixation at presentation with severe optic progression nerve damage • AGIS: only the lowest IOP group (mean = 12 mmHg) no progression • Initial extent of VF loss is greatest predictor of further VF loss Primum non nocere: Meds first! Poor compliance and adherence • There is no harm in giving medications a TRIAL first • If they fail, you have not done any irreversible • Multiple medications leads to non-adherence damage and can move quickly onto surgical options • Even adherent patients may have allergy or poor efficacy • Surgery is higher risk in advanced glaucoma • Leads to delay in IOP control patients and can lead to ”snuff out” • Leads to progression and blindness • 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 6
12/4/2015 Primum non nocere: Surgery first! Management of Newly Diagnosed Advanced Glaucoma: Medications or Surgery? • 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 outcomes than patients who went on medications New medication delivery systems will Thank you! improve adherence • Injectable formulations such as microspheres, liposomes, nanoparticles • Subconjunctival injections • Conjunctival inserts • Sub-Tenon’s injections • Intravitreal inserts • Punctal plugs • Contact lenses 7
12/4/2015 CIGTS: Health-related quality of life One can achieve target IOPs with medications • No statistically significant difference on total score for • In CIGTS at 5 years, no statistically significant difference visual activities questionnaire in the risk of failure of randomized treatment, defined as need to crossover from medicine to surgery or vice-versa • 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) The “perfect” glaucoma surgery does not yet exist • Effective • “Among the implications of these results to clinical practice, perhaps the most important is the limited – As or more effective than drops or laser amount of VF loss that occurred over extended – Lowers IOP enough to prevent further damage but not too low follow-up . The authors attribute this to the attention paid • Safe both intra- and post-operatively in the CIGTS to IOP control, which likely was much • Relatively easy to perform stricter than what occurs in the community. The VF outcomes for those with more advanced VF loss at • Burns no bridges baseline, in whom surgery was advantageous, and the • Repeatable outcomes for diabetics, in whom surgery was • ? In-office procedure disadvantageous, are important.” • Cost effective 8
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