Informed Consent for Intravitreal Injection

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Informed Consent for Intravitreal Injection

Patient and Procedure Information

Nature and Purpose of the Procedure

An intravitreal injection is the administration of medication directly into the vitreous cavity (the jelly-filled space in the back of the eye) to treat diseases of the retina and macula. This treatment is commonly indicated for conditions such as wet age-related macular degeneration (AMD), diabetic macular edema, retinal vein occlusion, and choroidal neovascularization. The procedure is performed in an outpatient clinic setting under topical or local anesthesia. The eye is cleaned with an antiseptic solution (typically povidone-iodine) to reduce the risk of infection, and a small speculum is placed to keep the eyelids open. The physician uses a fine needle to inject the designated medication through the sclera (the white part of the eye). The injection itself takes only a few seconds. The physician will check the eye immediately post-injection to confirm light perception and normal retinal artery perfusion.

Need for Repeat Injections

Intravitreal therapy is generally not a one-time treatment. Pharmacological agents, particularly anti-VEGF (vascular endothelial growth factor) inhibitors, degrade over time and must be re-administered to maintain their therapeutic effect. Depending on your specific diagnosis and clinical response, you may require injections on a regular schedule (typically every 4 to 12 weeks) for an extended period, which could span several years. Your ophthalmologist will monitor your progress using optical coherence tomography (OCT) and clinical examinations to determine the ongoing frequency of injections.

Material Risks and Potential Complications

Endophthalmitis: a severe intraocular bacterial or fungal infection occurring in approximately 1 in 2,000 injections. Symptoms include worsening pain, progressive redness, and loss of vision, typically developing 2 to 5 days after the injection. Endophthalmitis is a medical emergency that requires urgent injection of intraocular antibiotics or surgery.
Intraocular pressure elevation: a transient increase in pressure immediately following the injection, caused by the volume of liquid introduced into the eye. This is common and usually resolves within an hour, but persistent elevation may require pressure-lowering drops or, rarely, a minor surgical decompression (paracentesis).
Systemic cardiovascular events (anti-VEGF class risk): there is a theoretical risk of arterial thromboembolic events (such as stroke or myocardial infarction) associated with systemic absorption of vascular endothelial growth factor inhibitors. This risk is extremely low but is carefully monitored in patients with a history of recent stroke or heart attack.
Vitreous hemorrhage: bleeding inside the eye from localized damage to blood vessels during needle insertion. This usually resolves spontaneously over several weeks but may cause floating spots or blurred vision.
Retinal tear or detachment: traction or damage to the retina caused by the needle or changes in the vitreous gel. This is rare (less than 1 percent) but requires surgical repair to prevent permanent vision loss.

Expected Benefits

The primary expected benefit of intravitreal injection is stabilization or improvement of visual acuity. Without treatment, diseases like wet AMD or diabetic macular edema typically lead to progressive, irreversible loss of central vision. While injections do not cure the underlying disease, they are highly effective in halting or slowing down abnormal blood vessel growth and leakage, thereby preserving functional vision.

Reasonable Alternatives to Injection

Laser photocoagulation: thermal laser treatment to seal leaking blood vessels. Laser treatment carries a risk of permanent localized blind spots and is less effective than injections for many macular conditions.
Photodynamic therapy (PDT): a combination of an intravenous drug and a non-thermal laser, occasionally used for specific macular diseases.
Observation: choosing no treatment, which carries a high risk of progressive, severe, and permanent central vision loss from bleeding, swelling, or scarring of the macula.

Right to Refuse or Withdraw Consent

You have the right to refuse this procedure or withdraw your consent at any time before the injection is administered without penalty or adverse effect on your medical care. Your ophthalmologist will discuss the visual prognosis associated with declining treatment.

Questions and Understanding Confirmation

I confirm that I have reviewed this consent form with my ophthalmologist. I understand the chronic nature of my condition, the necessity of repeated injections, the small risk of serious infection (endophthalmitis), and the theoretical systemic stroke risk. All my questions have been answered.

Language Access and Interpreter Services

If English is not your primary language or if you require assistance communicating, a qualified medical interpreter is available to you at no cost. Please notify your care team if you require interpreter services before signing this document.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this informed consent form for my own records. I understand I may request an additional copy at any time from the facility or clinical records department.

Patient Authorization

I have been informed of the intravitreal injection procedure, its expected benefits, the material risks listed above, the chronic nature of the therapy, and available alternatives. I consent to receive the planned intravitreal injection in the target eye(s) indicated above.

Signatures and Verification

Patient / LAR Signature
Physician Signature
Witness Signature
Date and Time of Consent
Document ID: CC-PENDING
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