Ocular Effects (Safety) Of Intracameral Vigadexa (Moxifloxacin/Dexamethasone) In Patients Who Underwent Phacoemulsification

This study aims to determine the ocular effects of intracameral preservative-free fixed dose combination moxifloxacin 0.5%-dexamethasone 0.1% (VigaDexa, Alcon) in perioperative phacoemulsification. Specifically, it aims to compare the endothelial cell count and central corneal thickness before and after phacoemulsification with intracameral VigaDexa. It will also describe the intraocular pressure (IOP), anterior chamber (AC) inflammation and macular edema (ME) after intracameral VigaDexa.

This is a single center, open-labelled clinical trial. Exclusion crtieria includes a complicated cataract surgery and those with ocular pathology that may impair achievement of best corrected visual outcome (BCVA) of 20/30 or better including glaucoma, uveitis, retinopathy, corneal & vitreous opacity and neuropathy. Those with history of allergy to moxifloxacin or increased IOP after previous steroid use were also excluded. 

Patients diagnosed with senile mature cataract of NO4/NC4 or better were invited for the study.  Pre-operative diagnostics included specular microscopy and macular OCT. Patients underwent standard phacoemulsification by a single surgeon and upon conclusion of the surgery, 0.1mL of moxifloxacin 0.5%-dexamethasone 0.1% (VigaDexa, Alcon) was injected at the anterior chamber through the sideport. All patients were given VigaDexa eyedrops as postoperative medication. Patients were monitored for BCVA, AC reaction and IOP at Day 1, Week 1 and Month 1 from surgery. Specular microscopy and macular OCT was done 1 month post-op. Increased IOP was managed through oral and topical anti-glaucoma medication. Data analyzed using paired t-test.

34 eyes were enrolled in the study. All patients achieved BCVA of 20/30 at 1 month post-op. The average pre-operative corneal endothelial cell density is 2764 /mm2  and postoperative corneal endothelial cell density is 2714 /mm2  (p-value 0.21). Pachymetry shows preoperative corneal thickness of 566 um  and post-operative corneal thickness of 569um (p-value of 0.88). 4 (12%) patients had an IOP of > 21mmHg by Day 1 and no patient had IOP of >21mmHg by 1 week and 1 month post-op. 15 (44%) patients had AC inflammation of +1 by Day 1 post-op. All patients had quiet AC at 1 month postop. 5 (15%) patients had postoperative retinal thickening more than 10% of their preretinal thickness (p-value 0.01) but none had cystoid macular edema.

There is no significant difference between pre-operative and post-operative corneal endothelium density and corneal thickness after use of perioperative intracameral vigadexa. No persistent increased IOP were reported by week 1. Few cases postoperative retinal thickening by macular OCT were observed but no diagnosis of cystoid macular edema noted. Intracameral preservative free fixed dose moxifloxacin-dexamethasone for endophthalmitis prophylaxis and inflammation control among phacoemulsfication patients is safe on human corneal endothelium with good postoperative outcome.