December 28, 2016
3 min read
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Ozurdex given at same time as PPV may help stabilize retinal conditions

Visual acuity improved an average of two lines in patients undergoing the combination treatment.

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A sustained-release dexamethasone device implanted during pars plana vitrectomy may be effective in pre-emptively reducing macular edema in patients with various underlying ocular diseases at risk for inflammation.

Researchers retrospectively reviewed the safety and effectiveness of Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) implantation in 15 eyes undergoing pars plana vitrectomy for indications including uveitis, age-related macular degeneration, central retinal vein occlusion, diabetic macular edema, hemiretinal vein occlusion, proliferative vitreoretinopathy, retinal detachment and subconjunctival hemorrhage. Lens status varied, with patients being phakic, pseudophakic or aphakic.

Of the 15 eyes of 14 patients, there were no complications either intraoperatively or at 1 month postop. At 3 months postoperatively, only two eyes of two patients with prior retinal detachment and proliferative vitreoretinopathy showed recurrent proliferative vitreoretinopathy (PVR) and re-detachment.

Visual acuity improved in seven of the 15 eyes, with an average improvement of two lines for the entire cohort. Furthermore, five of nine eyes with baseline cystoid macular edema saw improvement or resolution at 3 months.

There was no overall change in IOP.

Vinit B. Mahajan

“Many of our surgical patients are at greater than average risk of postoperative inflammatory complications,” co-author Vinit B. Mahajan, MD, PhD, a clinical assistant professor of ophthalmology and visual sciences at the University of Iowa, said. “These include patients with uveitis, diabetic macular edema, vein occlusions, and some patients with macular degeneration and intraocular fibrosis.”

Mahajan said that he and colleagues were aware that these patients were likely to require steroid therapy at some point after surgery. “Because the usual intravitreal steroids rapidly leave the eye, especially in vitrectomized eyes, we considered pre-emptively treating patients with a sustained-release steroid at the time of surgery,” Mahajan told Ocular Surgery News.

Patient convenience

“Overall, the patients did well,” Mahajan said of the study that appeared in Retina. “Injection in the OR was also far more convenient than injections in clinic during the early postoperative period, when patients may be experiencing discomfort from the vitrectomy.”

The authors think that several patients healed faster with better visual outcomes at 3 months than they would have otherwise.

Figure 1. Intravitreal dexamethasone implant (A) during pars plana vitrectomy following an air-fluid exchange. Injection (B) is performed at the pars plana intraoperatively.

Image: Mahajan VB

“Interestingly, there is an ongoing debate on whether steroids should be used to treat or prevent PVR,” Mahajan said. “Despite the highly potent, localized and sustained steroid you achieve with Ozurdex, we did not prevent PVR. I think this calls into question how much potential benefit we derive from steroids for PVR.”

For the study cases, the implant was injected at the end of surgery, before cannula removal, under direct visualization with an infusion running, “so the eye was normotensive,” Mahajan said. “The injection needle was also aimed away from the macula.”

The implant was injected 4 mm posterior to the limbus with a beveled incision at the 5 or 7 o’clock position.

Visual acuity results

Mean baseline visual acuity ranged from 20/30 to hand-motion vision, with an average gain of 12.5 letters of vision, or almost three lines, at 1 month postop. Specifically, six of 15 eyes (40%) attained an improvement in visual acuity, whereas three of 15 eyes (20%) had worse vision.

Visual findings were similar at 3 months.

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“[W]e found that addition of intraoperative Ozurdex injection to PPV did not result in unexpected perioperative surgical complications, and overall, appears to stabilize retinal conditions during the postsurgical clinical course,” the authors said in the study.

Mahajan said it was important to add the procedure to informed consent. “Prior to treatment, we discussed the benefits and risks of intraoperative Ozurdex injection with the patient, including the risk of migration into the anterior chamber, elevated IOP, cataract, retinal detachment and the need for further treatment,” he said.

Many of the patients previously experienced in-clinic intravitreal injections. “Therefore, they were happy with the convenience of receiving the injection during their vitrectomy surgery,” Mahajan said.

A major focus of Mahajan’s laboratory is using vitreous proteomics to understand the molecular effects of intravitreal drugs. “We have ongoing studies to identify protein biomarkers in vitreous biopsies, both before and after therapy,” Mahajan said. “Once we know how these drugs work and sometimes fail at the molecular level, we will be able to apply more rational, predictable, personalized medicine approaches to our patients.” – by Bob Kronemyer

Disclosure: Mahajan reports no relevant financial disclosures.