Update on Clinical Outcomes After Trabectome TM Surgery For Open-angle Glaucoma

Transcription

1 Update on Clinical Outcomes After Trabectome TM Surgery For Open-angle Glaucoma Don Minckler 1, Brian Francis 2, Sameh Mosaed 1, Marina Ramirez 3, Laurie Dustin 2 1 UC Irvine, Irvine CA; Ophthalmology 2 USC, Los Angeles CA; Ophthalmology & Biostatistics 3 Codet Eye Institute, Tijuana, Mexico Minckler & Francis are paid consultants for NeoMedix

2 return 800 µm active Modified Swan-Jacobs goniolens Trabectome TM Tip 800 X 230 X 110 µm Foot pedal controlled continual aspiration & infusion

3 In vitro model inverted corneal donor rim Control After Trabectome TM

4 TrabectomeTM removal of TM [human autopsy eye; Courtesy of Doug Johnson] cornea TM collector channel intact Unroofed Schlemm s cut CB remnants 1 mm 50 μm

5 Trabectome TM removal of meshwork cells visible on outer wall of Schlemm s canal [human autopsy eye; Courtesy of Doug Johnson] anterior TM outer wall Schlemm s canal Intact cell on back wall of Schlemm s canal 100 m

6 Meshwork strip adherent to tip of Trabectome TM (courtesy of Brian Francis) 1.2 cm strip (H & E orig. X 3.12) (H & E orig. X 50)

7 Trabectome TM [Modified Swan-Jacobs Goniolens] intraoperative apraclonidine (0.5%); 1.6 mm incision; viscoelastic (Ocucoat); suture; air bubble optional; Simcoe optional

8 Trabectome TM Adjunctive Medications Update through 5/07

9 Trabectome TM Survival (N = 101) to 36 months (n = 5 )

10 IOP (mmhg) IOP Outcomes: 358 cases total (data incomplete at various times) IOP + % IOP < Pre-op IOP (w or w/out Rx) % 1 day % 1 Week % 2 Weeks % 30 1 month % 2 months % 3 months % 25 4 months % 5 months % 20 6 months % 7 months % 8 months % Months After Surgery 9 months % 10 months % 11 months % 12 months % 13 months % 18 months % 21 months % 24 months % 30 months % 36 months % 40 months % Total Mean % N = 42 N = 23 N = 6

11 Trabectome TM Complications Update through 5/07 Total number of surgeries analyzed (US and Mexico) 358 combined phacoemulsification & Trabectome TM 99 Infants/juvenile (2 weeks 18 years) 5 Clinically obvious intraoperative blood reflux or angle hemorrhage at surgery + 95% Corneal injury Epithelial defects (persisting beyond day 1) 5 Decemet s hemorrhage 1 Decemet s scroll 1 Persisting Decemet s injury 1 Post-operative focal PAS noted gonioscopically 10 Goniosynechiae 5 Complete cleft closure documented gonioscopically 0 IOP spikes/failures IOP spikes 1-Day postoperatively (> 21mmHg) 63 Subsequent trabeculectomy (weeks to months) 25 Subsequent shunt 5 Eyes lost to F/U (patient deaths) 3 Repeat Trabectome TM (all by patient request prior to subsequent surgery 4 Iris injury (subsequent to iris-prolapse at end of surgery) 4 Cyclodialysis 0

12 Complications of trabeculectomy Not seen in this series to date: Flat Anterior Chamber Choroidal Effusion; choroidal hemorrhage Persisting corneal edema Clinically significant iris injury Hypotony maculopathy Infection Cataract progression over subsequent months is rare (1 in first 101 cases - VA down > 2 lines) Wound Leak Bleb formation

13 Trabectome TM Perspectives & Clinical Applications Open angle and clear gonioscopic view Expected IOP range mmhg Safer; simpler follow-up; low complication rates compared to trabeculectomy (no late infection risk; no bleb) Fits into therapy spectrum before trabeculectomy or other filtering procedures -? Alternative to LTP/medication in some patients Does not preclude subsequent surgery (spares conjunctiva) Alternative to traditional goniotomy or trabeculotomy in children Easy skill transfer (23 surgeons involved) Study Group Goals: prospective data collection on 1000 cases (stable protocol) Consensus design of RCTs Multi-center Laser/medicine vs Trabectome TM Trabectome TM vs trabeculectomy Trabeculotomy/goniotomy vs Trabectome TM in children

14 Participating Centers providing follow-up data 1. Chapman Hospital & USC-Doheny (Francis) 2. Codet Aris (Ramirez) 3. UCI (Baerveldt, Minckler, Mosaed) 4. VA-Long Beach (UCI supported Faculty - Mosaed) 5. Mayo Clinic (Johnson, Sit) 6. Scripps Clinic (Nguyen) 7. Mass Eye and Ear Infirmary Harvard Med School (Rhee) 8. Kaiser Permanente (Rosenquist, Song, Ghiasi) 9. Shiley Eye Institute (Weinreb) 10. Harton Medical Hospital (Mahan) 11. Palmetto Hospital (Mitchell) 12. South Carolina VA hospital (Mitchell) 13. Loma Linda Hospital (Tamesis) 14. Wolfe Eye Clinic (Trible) 15. New York Eye and Ear (Sidoti) 16. Northwest Glaucoma Consultants (Johnstone, Mills, Jamil) 17. Dobbs Ferry Hospital (Donas) 18. Silverdale Surgical Center (Leen) 19. Kapio Lani Hospital (Tanji) 20. JC Blair Hospital (Patistas)