Contralateral Randomized Comparison Between Intracameral Extended-Release Dexamethasone 9% Suspension Placed in the Capsular Bag with the Established Post-Cataract Regimen.

INTRODUCTION

This study aimed to compare the safety and efficacy of intracameral dexamethasone 9% single-dose sustained-release suspension with the established pharmaceutical regimen after cataract surgery.

METHODS

This prospective self-controlled study included consecutive patients with bilateral visually significant cataracts. Patients received bilateral cataract extraction in the Eye Institute of West Florida by the same experienced surgeon (RJW). One randomly selected eye of every patient received a sustained-release dexamethasone 9% suspension placed in the capsular bag at the optic-haptic junction of the intraocular lens (study group); post-cataract topical regimen included topical antibiotic and NSAID. The other eye (control group) received only topical pharmaceutical agents after cataract extraction, which included the same antibiotic and NSAID as the fellow eye along with a steroid. All patients were followed at day 1, 7, and 30 after cataract surgery and visual acuity, manifest refraction, subjective anterior chamber inflammation grading, subjective patient pain score (questionnaire) along with specular microscopy of the cornea and optical coherence tomography of the macula were evaluated.

RESULTS

Forty-eight eyes of 24 patients (16 female and 8 male), aged 69.54 ± 7.36 (range 54-85 years), were included in the study. All patients completed the follow-up, while none of the study eyes required additional topical treatment for inflammation control. Anterior chamber inflammation, assessed using the Summed Ocular Inflammation Score (SOIS), demonstrated a mild inflammatory response postoperatively, which resolved over time in both groups. On postoperative day 1, SOIS was slightly higher in the study eyes (1.12 ± 0.23) compared to the control eyes (0.92 ± 0.34, p = 0.054). By day 7, inflammation had significantly decreased (study: 0.16 ± 0.23; control: 0.17 ± 0.20, p = 0.88), with no residual inflammation at the final follow-up. Uncorrected and corrected distance visual acuity, intraocular pressure, anterior chamber inflammation, corneal endothelial cell density, and central retinal thickness demonstrated no significant difference between the study and control group throughout the follow-up (p > 0.05). None of the patients reported pain after either procedure, while no intra- or postoperative complications were noted in any of the eyes.

CONCLUSIONS

The use of intracameral dexamethasone 9% sustained-release suspension placed in the capsular bag at the time of cataract surgery seems to offer similar safety and efficacy as the established post-cataract topical regimen. Furthermore, no signs of iris atrophy were evident in any of the eyes up to 1 month post cataract surgery.