Guidelines Intravitreal Therapy

Issued: August 2006 of 7 G.06/26

The Royal Australian and New Zealand

College of Ophthalmologists

GUIDELINES FOR PERFORMING

INTRAVITREAL THERAPY

Guidelines

Information Sheet and Consent Form

Instructions for Patients


GUIDELINES FOR PERFORMING INTRAVITREAL THERAPY

Aim:

The aim of this document is to provide ophthalmologists with a practical set of guidelines that will enable them to safely perform intravitreal injection therapy. Specifically this document aims to provide the ophthalmologist with guidance as to where and how to perform intravitreal therapy. There are some important post-operative principles that need to be followed but the specific follow-up details depend on the drug that has been injected and are beyond the scope of this document. Location: There is clear evidence from multiple prospective clinical trials involving the anti VEGF agents, that it is not necessary to perform intravitreal injections in operating theatres. In these large multi-centre trials, the therapy was given in consulting rooms, outpatients and minor procedure rooms. The frequency of complications in these locations was extremely low and the evidence from these studies shows clearly that it is safe to give these injections outside operating theatres, as long as the correct patient preparation and technique for intravitreal injections are followed. Intravitreal Therapy Technique – A Step-by-Step Guide 1. Pre-treatment counselling and consent

It is essential to obtain informed consent for intravitreal therapy and such informed consent must contain a clear explanation of vision threatening complications of an intravitreal injection. Specifically, the patient needs to be informed of the risk of endophthalmitis (0.4 – 0.8% per patient; 0.06 - 0.16% per injection), retinal detachment (0.0 – 1.0% per patient), traumatic cataract (0.4 – 0.6% per patient) and significant vitreous haemorrhage (0.4% per patient). In patients getting triamcinolone the risk of a steroid induced intraocular pressure rise must be discussed. There is also clear evidence that intraocular triamcinolone results in cataract development and progression. The use of a printed information sheet may be a useful adjunct for informed consent and a sample document is included in these guidelines (Annex A).

It is also essential that the patient understands how to contact the ophthalmologist or clinic where the intravitreal injection was performed, following treatment if they have a problem. A sample instruction sheet is attached (Annex B).

2. Pre-operative assessment

Active ocular surface infection should be controlled and treated prior to the use of the intravitreal therapy. Many patients take anti-platelet agents or oral anti-coagulants. It is not necessary to cease these medications prior to the intravitreal therapy. With intravitreal steroid injections in particular, there is significant controversy regarding the use of such agents in patients who are steroid responders. It is beyond the scope of these guidelines to provide specific information in this area and ophthalmologists need to make an individualised decision regarding the safety of intravitreal steroids in patients who are steroid responders and in those who have pre-


existing glaucoma. Additionally, patients with a history of herpetic keratitis need careful assessment as it is recognised that intraocular steroids may be contraindicated in patients with active herpetic keratitis.

3. Pre-operative preparation

• Table 1 lists the equipment necessary to perform intravitreal injections. It is suggested that the instruments be supplied as a pre-prepared sterilised pack for convenience.

• The pupil should be dilated prior to treatment. • At a minimum, topical anaesthetic is necessary for intravitreal therapy. However,

many ophthalmologists additionally use subconjunctival anaesthetic injections at the proposed site of intravitreal injection.

• The most critical step pre-operatively, is to use 10% povidone iodine to clean the eyelids and to irrigate the ocular surface and conjunctival sac. Some clinical trials used pre operative antibiotics and their use before intravitreal therapy is left to the individual ophthalmologist’s discretion1.

• It is necessary to use a lid speculum to ensure that the eyelashes and margins of the eyelid do not contaminate the syringe and needle during injection. Sterile gloves should be worn. The use of a sterile drape is left to the individual ophthalmologist’s discretion.

4. Injection technique

A sterile syringe and needle are used to give the intravitreal injection. A 27 gauge needle is required to inject triamcinolone given its particulate nature, while a 30 gauge needle can be used for other drugs. Pre-swaged insulin syringes are very useful for giving intravitreal injections. It is recommended that the conjunctiva be displaced slightly with a cotton bud prior to beginning the injection so that the conjunctival entry point is slightly separated from the scleral entry point. This allows a better wound seal post injection. The injection should be given 3.5mm from the limbus in a pseudophakic eye and 4mm from the limbus in a phakic eye.

5. Post injection management

(a) The intraocular pressure is increased for several minutes following an intravitreal

injection and it is extremely common for there to be non-perfusion of the optic nerve head and retina for several minutes following injection. This is typically accompanied by significant visual loss or total loss of vision in the injected eye. In the vast majority of patients, vision returns within 3-5 minutes as the intraocular pressure returns to normal. It is rarely necessary to perform an AC paracentesis and this should only be performed if the intraocular pressure fails to settle with time and ocular massage.

1 a) Aeillo LP, Brucker AJ, Chang S, Cunningham E, et al. Evolving guidelines for intravitreal injection. Retina 2004; 24:S4-S19.

b) Ta CN. Minimising the risk of endophthalm itis after intravitreous injection. Retina 2004; 24:699-705.

c) Jager RD, Aeillo LP, Patel SC, Cunningham E, et al. Risks of intravitreous injection: a comprehensive review. Retina 2004;

24:676-698.


Post injection topical antibiotics following have been used in all the large clinical trials of intravitreal therapy and are therefore recommended for 3-5 days following injection.

(b) It is critically important that the patient is aware that severe pain, visual loss or

injection of the globe require urgent re-assessment by the ophthalmologist and a mechanism must be in place to allow the patient to contact the treating ophthalmologist or a member of the team urgently after hours. Endophthalmitis typically occurs within five days of the injection and the presentation may be atypical particularly if steroids have been injected intravitreally. The precise follow-up regimen following intravitreal therapy needs to be individualised dependent upon the medication that has been injected and precise guidelines are beyond the scope of this document.

(c) Some drugs, particularly intravitreal triamcinolone, have additionally been

associated with a sterile non- infectious form of severe intraocular inflammation sometimes termed “sterile endophthalmitis”. The differentiation between infectious and non- infectious post-injection inflammation in eyes following intravitreal injection, may be impossible and whenever there is doubt, the eye should be managed as if it has infective endophthalmitis using standard treatment. Such management typically involves vitreous and aqueous taps for microbiology followed by intravitreal broad spectrum antibiotics. Precise treatment guidelines are beyond the scope of this document.

Summary 1. Safe to give intravitreal therapy in clinic setting 2. Informed consent essential 3. Povidine iodine +/- topical antibiotics pre injection 4. Topical +/- subconjunctival anaesthesia 5. Lid speculum, sterile gloves +/- sterile drape 6. AC paracentesis rarely needed post injection 7. Topical antibiotics post injection 8. Follow up regimen depends on drug injected 9. Mechanism to contact Ophthalmologist urgently post injection Table 1: Pack for intravitreal therapy 10% povidine iodine & swabs syringes, needles sterile lid speculum sterile gloves +/- sterile drape topical +/- subconjunctival anaesthetic topical antibiotics Annexes: Annex A: Information Sheet and Consent Form Annex B: Instructions for Patients following Intravitreal Injection


ANNEX A Intravitreal Injections

Information Sheet and Consent Form

What is an intravitreal Injection? An intravitreal injection is an injection into the vitreous which is the jelly like substance inside your eye. It is performed to place medicines inside the eye, near the retina. Why is an intravitreal injection performed? Intravitreal injections are used to deliver drugs to the retina and other structures in the back of the eye, thus avoiding effects on the rest of the body. Common conditions treated with intravitreal injections include diabetic retinopathy, macular degeneration, retinal vascular diseases and ocular inflammation. What is the intravitreal injection procedure? Once your pupils are dilated, the actual procedure takes around 15 minutes. We will lie you in a comfortable position. Anaesthetic (numbing) drops will be placed in your eye and your eye and eyelids will be cleaned with an iodine antiseptic solution. This may initially cause a stinging feeling. The eye is held open with an instrument (speculum). The medicine is then injected into your vitreous: you may feel slight pressure and a momentary sharp feeling on the eye when this is done. After the injection procedure, the doctor will check your eye and your eye will be padded. You will be given antibiotic drops or ointment to use at home. What are the side effects? After the injection into your eye you may have a gritty feeling in the eye, and the eye might look bloodshot. These will resolve over a few days. You might see floaters which will become smaller and disappear over one to two weeks. Are there any risks? Injecting any medication into the eye may result in increased pressure within the eye, inflammation, or more serious side effects such as cataract formation, bleeding within the eye, damage to the retina (retinal detachment or tear) or other eye structures. These side effects are rare, estimated at less than 1 per 1000 injections. It is possible that you may get an infection within your eye (endophthalmitis) as a result of the intravitreal injection. The chance of an infection is low (estimated at 1-2 per 1000 injections). An infection may lead to vision loss or, in rare cases, loss of the eye. What else do I need to know? Please allow at least 1 hour for your appointment. This will allow dilation of your pupils, the injection, and review afterwards by your doctor. Before you leave, you will have another appointment made for review, depending on the type of injection you have received. You will receive a follow-up phone call after the injection to check how your eye is going,


Preparation for the injection It is very important for you to tell us about any health conditions that you have, all the medications that you are taking, and especially any allergies to medications that you have had in the past. You will be asked to sign this form on the day of your appointment. I, _____________________________________ have read, or have had read to me, the

above information concerning the procedure of intravitreal injection and understand it to my

satisfaction.

I consent to the procedure being performed _____________________________ / / Witness _____________________________ / /


ANNEX B

Instructions for patients following intravitreal injection

Name: …………………………………………………………………………………..

Date: …………………………………..

You have had an injection of ………………………………………………………….

into your right / left eye

Ø Please try to keep your eye closed under the eye pad: you may remove it in two hours.

Ø Please use the antibiotic ointment four times a day for four days.

Ø Paracetamol or a simple analgesic may be taken if necessary.

You may notice any of the following over the next two days:

Ø Foreign body sensation or grittiness of the eye: this can be quite severe in the first few hours after the treatment if you have accidentally opened the eye under the pad and have scratched the cornea (front window of the eye). This usually heals within 24 hours.

Ø Mild redness of the eye

Ø Blurry vision

Ø Floaters or “blobs” in your vision: these will become smaller and disappear over a few week

You will be given an appointment for your next check, and next injection if necessary, at the reception desk before leaving. Please report if you have any of the following

Ø Severe pain

Ø Marked worsening of vision or loss of vision

In case of emergency please call ******, or go to the Emergency Department at ******

Guidelines Intravitreal Therapy

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