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TRAVOPROST IMPLANT

Clinical Criteria Summary

Document 641

Exclusion Criteria

  • Ocular or periocular infection
  • Corneal endothelial dystrophy
  • Prior corneal transplant
  • Prior treatment with travoprost implant in affected eye
  • Active intraocular inflammation

Inclusion Criteria

  • Provider is a VA/VA Community Care ophthalmologist
  • Diagnosis of open-angle glaucoma or ocular hypertension
  • Unable to use at least one topical agent from each drug class, OR is using a topical agent and requires additional intraocular pressure lowering but unable to use at least one topical agent from remaining drug classes
  • Among the agents tried, at least two were preservative-free or contained a non-benzalkonium chloride preservative
  • Laser trabeculoplasty is contraindicated or has not had adequate response to prior laser treatment

Device & Procedural Requirements

  • Implant is Magnetic Resonance Imaging (MRI) Conditional
  • Patients must be informed that the implant is MR Conditional per their Patient ID card
  • Patients requiring MRI must inform their healthcare provider of the implanted device
  • Product labeling conditions for safe scanning must be followed to prevent patient injury

Document 659

Indication

  • Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Patient Selection Criteria

  • Inclusions
  • ≥18 years old
  • Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
  • Currently on 0-2 topical glaucoma medications
  • Mean diurnal IOP and individual IOP 21-36 mmHg at baseline visit
  • Central corneal thickness (CCT) 440-620µm
  • Open iridocorneal angle (Shaffer grade ≥3) with normal anatomy
  • Best-corrected visual acuity (BCVA) ≥20/80 Snellen
  • Exclusions
  • Cup/Disc ratio > 0.8
  • Visual field mean deviation of -12dB or worse
  • Active ocular inflammation
  • Prior argon laser trabeculoplasty or incisional glaucoma surgery

Contraindications

  • Ocular or periocular infection
  • Corneal endothelial dystrophy
  • Prior corneal transplant
  • Hypersensitivity to travoprost or components

Warnings & Precautions

  • Use with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or other angle abnormalities that could impair proper placement of iDose TR at the planned implantation site
  • Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or known risk factors for macular edema
  • Active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated
  • Device dislocation; if implant becomes dislocated, it should be surgically removed
  • Increased pigmentation of the iris can occur and is likely to be permanent
  • MRI Conditional status: Patients must inform healthcare provider that they have an iDose TR implanted in the eye if requiring MRI
  • Intraocular inflammation
  • Endophthalmitis
  • Macular edema

Administration & Dosing

  • Administered intracamerally through a small, clear corneal incision and anchored into the sclera at the iridocorneal angle
  • Inserted directly through the trabecular meshwork of the anterior chamber angle into the sclera
  • Requires implantation in an operating room
  • Do not readminister to an eye that received a prior travoprost implant

Clinical Guidance & Place in Therapy

  • Limited to patients who are unable to use topical agents, including preservative-free or non-benzalkonium chloride agents
  • Appropriate when laser trabeculoplasty is contraindicated or has not had adequate response to prior laser treatment

Source Documents