Epioxa Consent Form

What is Epioxa?

Epioxa strengthens the cornea using topical drops, light and oxygen to help halt or slow the progression of keratoconus. It is the only FDA‑approved, oxygen‑enriched corneal cross‑linking treatment that does not remove the outer layer of the cornea. Epioxa is approved for adults and for pediatric patients 13 years and older.

Epioxa is contraindicated in patients who:

• Have a known hypersensitivity to any ingredients in the product
• Have had cataract surgery and either did not receive an artificial lens in your eye or received a non-UV blocking artificial lens
• Have a history of herpetic keratitis, or are pregnant.

Risks

•  The most common side effects were red eye, haze, sensitivity to light, disruption of surface cells of the cornea, eye pain, eye irritation, watery eyes, swelling of eyelid, fine white lines in the cornea, reduced sharpness of vision, dry eye, and eye inflammation.
• For complete information, please see full Prescribing Information by visiting www.epioxa.com
• Contact your doctor immediately if you experience severe pain in the treated eye or any sudden decrease in vision.
• You may feel some discomfort in the treated eye. Wearing sunglasses may help if you are sensitive to light after the treatment. Go home and rest. Do not rub your eyes. Take medications as prescribed by your doctor.
• You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also call Glaukos at 1-888-404-1644.

Note: The chances of developing the above risks are not known and no controlled studies have been completed as to the knowledge of your practitioner. Risks and complications that are considered to be unforeseeable, remote or not known yet, are not discussed. 

* The above risks may be reduced, but are still possible, with the use of absorbable plugs

Consent for Treatment

By signing, I am voluntarily consenting to have the Epioxa treatment performed on me. I acknowledge that my healthcare practitioner has recommended Epioxa for me and that the treatment and potential side effects have been fully explained to me. I also confirm that I have read the above, understand it, and that my questions have been answered satisfactorily by my healthcare practitioner. I accept the risks and complications of the treatment and I understand that no guarantees are implied as to the outcome of the procedure. I understand that any treatment performed is between me and my healthcare practitioner, and I will direct all post-operative questions or concerns to them. I confirm that I do not have any of the above contraindications of treatment, and that I will notify my healthcare practitioner immediately if I experience any side effects.