Glaukos Study

Glaukos Inclusion/Exclusion GC-012 Criteria:  3-Year Study

Inclusion Criteria:

  • Age 18 or older
  • OHT or OAG
  • OAG criteria
    • ≤ 0.8 vertical C/D ratio
    • Visual field defects OR
    • Nerve abnormality
      • Neuroretinal Rim notching
      • Disc Hemorrhage
      • Nerve fiber layer loss
  • 0 to 2 medications
  • IOP ≥ 21 mm and ≤36 mm Hg if on no meds
  • BCVA ETDRS 20/80 or better
  • Angle Shaffer grade ≥3
  • Pt able to provide adequate interpretable visual field 24‐2 SITA standard ‐12 dB or better
  • Phakic or Pseudophakic
  • Diurnal IOP after medication wash out ≥21 and ≤36
  • Prior refractive surgery ok as long as it doesn’t interfere with IOP reliability

 

Exclusion Criteria:

  • Traumatic, Uveitic, Neovascular, or Angle‐Closure glaucoma
  • Prior Glaucoma surgery, filtration, incisional, ALT, Iridectomy/Iridotomy, trabecular bypass, or suprachroidal
  • History of SLT/MLT within 90 days
  • Expected unmedicated IOP after washout to exceed upper limit of 36 mm Hg
  • Visual Field status placed at risk by washout period
  • If Phakic, must not have cataract that is visually significant and require surgery within next 3 years
  • If Pseudophakic, must have PC IOL in the capsular bag
  • Central Corneal Thickness <440 microns or > 620 microns
  • Corneal dystrophy, opacities, edema, scarring or anticipated LASIK, LASEK, PRK, etc

 

Glaukos Outreach Program:

To get started:  Identify your patients who meet the minimum criteria on the Glaukos Clinical Study Outreach Program Next Steps:

  • Complete the one‐page Glaukos Clinical Study Outreach Program iDose™ Travoprost Intraocular Implant page (including the patient’s name; date seen in your office; check every “Yes” and “No” box).
  • Ask if the patient is interested in learning more about participating in an FDA approved, clinical trial for glaucoma.
  • If the patient is interested, walk the patient to reception; call our study dept @ (570) 714‐5910 to schedule a study screening appointment for the
  • Note the date/time of the appointment on the iDose™ Travoprost Intraocular Implant page along with your clinic’s name and obtain the patient’s
  • Give the patient an appointment card with the date/time of their study screening appointment and the address of 703 Rutter Ave, Kingston, PA 18704
  • Email or Fax the 1‐page Glaukos Clinical Study Outreach Program iDose™ Travoprost Intraocular Implant sheet to:

Patti Myers, Clinical Research Manager

Email: pmyers@icarespecialists.com

Fax:  (570) 718-6712

Feel free to call Patti at (570) 714-5910 for more information about referring patients into this study.

MIGS procedures provide patients with important new options in glaucoma therapy. It is an exciting time for us and our patients in the evolution of glaucoma management. We believe this clinical trial is an important part of this advancement. If we can answer additional questions for you regarding adding this treatment to your portfolio of offerings that may benefit your patients, please contact us.

You can find more details about the Glaukos iDose™ Travoprost Intraocular Implant clinical trial at www.glaukosclinicaltrials.com