[Reliability and safety of intravitreal Ozurdex injections. The ZERO study].

BACKGROUND

Since July 2010 Ozurdex® is approved in Germany for treatment of macular edema from retinal vein occlusion (RVO). The objective of this observational study was a systemic summary and analysis of clinical experience regarding complications and side effects of intravitreal administration of dexamethasone.

PATIENTS AND

METHODS

In a retrospective, multicenter study conducted at 10 centers, 342 eyes with RVO were treated with intravitreal dexamethasone (Ozurdex®, Allergan). After treatment the patients were followed-up over a period of 8 months and intraoperative, perioperative and postoperative complications, such as elevated intraocular pressure and dislocation of implants were systematically recorded.

RESULTS

No infections, endophthalmitis, perioperative hypotension, intraoperative lens injuries or retinal detachment occurred. Elevated intraocular pressure was the most common complication accounting for nearly 20 %. In 9 % of patients the intraocular pressure increased by more than 10 mmHg compared to baseline and in 6 patients to > 35 mmHg. In cases of known glaucoma intraocular pressure elevation was not significantly more frequent compared to non-glaucoma patients. In four cases a progression of lens opacity led to phacoemulsification and two implant dislocations in the anterior chamber required surgical repositioning in the vitreous cavity. In two cases a postinterventional macular hole was observed.

CONCLUSIONS

In the clinical routine Ozurdex treatment has proven to be a therapy method with minimal side effects. In Ozurdex administration intraocular pressure elevation was observed as the most common side effect; however, this generally did not require surgical intervention. Caution is advised in patients with an anterior chamber lens and iridectomy. Macular holes as a rare complication might result from vitreous traction during the administration process. In summary, even in the clinical routine application of Ozurdex the complication rate was not higher than in registration studies.