In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study

Abstract

Purpose To evaluate the clinical outcomes with optometrist pre-surgical insertion of dexamethasone ophthalmic insert 0.4mg in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy. Methods In this prospective, contralateral eye trial, one eye received a dexamethasone ophthalmic insert 0.4mg and the other received topical prednisolone acetate 1% four times per day for one week, then three times per day for one week, then two times per day for one week, and then one time per day for one week. At one day, seven days, and four weeks postoperatively mean anterior chamber cell score and mean anterior chamber flare score was assessed by Slit Lamp Biomicroscopy and pain score was assessed by Visual Analog Scale from 0–10. Incidence of increased intraocular pressure and cystoid macular edema were also assessed. Results Thirty patients (60 eyes) participated. At one day postoperative there was no significant difference in mean anterior chamber cell score (p= 0.70) or pain score (p= 0.92). There was no anterior chamber cell flare observed in the study or control group. Of the 30 patients, 29 expressed a preference for dexamethasone inserts compared to topical prednisolone acetate. One patient in the study group had elevated intraocular pressure that resolved and there was no cystoid macular edema measured. Conclusion In patients undergoing routine cataract surgery, there was an overwhelming preference for a dexamethasone insert compared to topical steroid drops. The dexamethasone insert produced similar ocular comfort and inflammation prevention compared to prednisolone acetate eyedrops. Dexamethasone inserts are a safe and effective treatment option for reducing pain and inflammation when inserted by an optometrist prior to routine cataract surgery.

Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation

“… 10 , 11 A study (PREPARE, n=60 eyes) evaluating Dextenza as a steroid delivery system following cataract surgery found a reduction in pain and inflammation comparable to topical steroid regimen controls. 12 Another study (RESTORE, n=20 subjects) evaluating Dextenza after PRK found that safety and visual outcomes were comparable with the topical steroid drop controls, with 70% preference for Dextenza reported among patients in the study. 13 Our recent publication exploring Dextenza as an adjunct to therapy, following corneal transplantation in 6 patients found Dextenza to be safe and comparable to the standard of care, as long as IOPs were monitored, and patients were screened for a past ocular history of punctal plug insertions.…”

“… 10 , 11 Another study reported a reduction in postoperative inflammation and pain in their Dextenza group that was comparable to controls using only topical steroid drop regimens, albeit the findings were derived from a relatively small sample size of 60 eyes. 12 Additionally, a study evaluating the effectiveness and safety of Dextenza following photorefractive keratectomy (PRK), found no significant differences in pain, healing time and visual outcomes between eyes with Dextenza and eyes using a topical steroid drop regimen. In their study, preference for Dextenza over the topical steroid regimen was reported in 70% of the patients.…”

Management of inflammation after the cataract surgery

“…Also, in Larsen and others' study, patients preferred dexamethasone implant when compared with topical steroid drops after undergoing bilateral refractive lens exchange [112]. In a recent study carried out by Ibach and others [113], patients undergoing routine cataract surgery preferred a dexamethasone insert (which was done 1 day prior to surgery) compared with topical steroid drops. Inflammation was measured as anterior chamber flare, which did not differ between the groups and no PCME was noted in either study group.…”

Ocular Inserets as a Modern Therapy Trend in Opthalmopathology

“…In assessing pain sensations statistically significant differences between the control and the main group were not identified. According to the survey, 29 participants of the study from 30 gave preference to Dextenza® therapy compared to traditional eye drops using [24].…”

“…Synthetic polymers and copolymers are stable as fully allow to predict of technological and biopharmaceutical parameters of the medical dosage form and improve its physical properties. As synthetic polymers in ophthalmology usually use derivative acrylic (carbomers) and methacrylic acid, polyvinyl alcohol, ethylene oxide polymers and their derivatives etc [24]. The wide use of polyvinyl alcohol is associated with its stability, biocompatibility and chemical inertness, making it safe for use in various dosage forms [25].…”