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    Time for a paradigm shift in the treatment of DME


    Patient selection

    As I discussed in my previous article, patient selection is critical. When contemplating steroidal treatments, selecting the right patients reduces the likelihood of exacerbating cataract development or increasing IOP, which are both commonly associated with corticosteroid therapies. Generally, pseudophakic patients make the best candidates; however, I must consider the risks and benefits with phakic patients and determine whether an advancing cataract is more important than the damage caused by DME. Patients with a cup to disk ratio > 0.8 are contraindicated for steroids, and I also rule out patients who have experienced a clinically significant increase in IOP in response to a topical or intravitreal steroid. Finally, I exclude patients with a compromised lens capsule or zonular dehiscence to avoid the possibility of implant migration to the anterior chamber, in addition to patients sensitive to floaters.


    What’s the alternative?

    For patients meeting the treatment criteria, I offer a long-term steroidal therapy (Iluvien, Alimera Sciences). The nonbioerodable implant is designed to deliver a continuous microdose of fluocinolone acetonide (FAc) to treat DME. Designed specifically for intraocular use, the tiny implant (3.5 mm x 0.37 mm) can have clinical efficacy for up to 36 months and may possibly eliminate, or at least significantly reduce, the need for and frequency of anti-VEGF or repeated steroid injections.

    Surgical technique: The Mali Maneuver

    I perform the implantation in the office following my typical sterile preparation protocol for an intravitreal injection, including using a lid speculum and betadine solution to sterilize the eye. Anesthesia protocol includes a subconjunctival injection of lidocaine in the region of the injection site.

    To prepare the injector, I remove it from the sterile packaging and look through the “window” to confirm that the implant is inside the injector. The little yellow implant is about 1/25th the size of a grain of rice, but it is easy to see through the clear window. The injector also has a safety feature to prevent the implant from coming out should the device be turned upside down. Next, I push the back end of the applicator button up to the black indicator mark. This removes air from the system and pushes the implant to the “ready” position.

    Implantation is a two-step process and is quite easy with the specially designed applicator. I prefer a two-handed technique to help with stabilization and control (“The Mali Maneuver”); otherwise, I perform the injection just as I do for any intravitreal injection: straight insertion (no bevel) 4 mm posterior to the inferotemporal limbus in the pars plana. Once inserted into the vitreous up to the marked point on the needle, I use my other hand to push the applicator button in a down-forward motion to release the implant into the vitreous.

    An empty applicator is my assurance of transference to the vitreous. However, I like to directly visualize the implant to confirm correct placement. To get a good view of the inferior retina, I have the patient lay back and look down in the chin up position.

    Case study

    Joshua Mali, MD
    Joshua Mali, MD, is a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Florida.

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