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