Phase IV clinical study to evaluate the effects of an intracameral combined mydriatic and anesthetic agent and standard topical mydriatics and anesthetics on the ocular surface after cataract surgery.

PURPOSE: To compare intracameral and topical mydriatics and anesthetics in cataract surgery. SETTING: Institute of Ocular Microsurgery, Barcelona, Spain. DESIGN: Phase IV, open-label, randomized, single-center study. METHODS: Patients were randomized in a 1:1 ratio to receive intracameral mydriatic-anesthetic (Mydrane/Fydrane) and anesthetic eyedrops or control (topical eyedrops only). The other treatment was administered for the second cataract surgery. Assessments were performed at presurgery and immediately postsurgery, at 12 to 36 hours postsurgery (day 1), and 7 days postsurgery. The primary endpoint was the change from baseline in corneal/conjunctival surface staining. The secondary endpoints included assessments of epithelial alterations, point-spread function, ocular surface disease index, conjunctival hyperemia, vision breakup time, ocular symptoms/signs, adverse events (AEs), corrected distance visual acuity, intraocular pressure, patient/investigator satisfaction, and procedure time. RESULTS: A total of 50 patients undergoing sequential cataract surgery in both eyes were included. Baseline assessments were similar in each group. The difference between Fydrane and control groups for the change from baseline at day 1 in corneal and conjunctival surface staining was not statistically significant. For Fydrane, postoperative epithelial alterations were fewer at day 1 (P < .005), folliculopapillary reaction was less frequent (P < .05), some ocular symptoms were less frequent and milder (P < .05), length of procedure was shorter (P < .001), and patient and investigator satisfaction were better (P < .05). There were few AEs in both groups. CONCLUSIONS: Fydrane reduced ocular surface damage by decreasing corneal epithelial and conjunctival toxicity with faster recovery of surface integrity compared with topical eyedrops, improved patient and investigator satisfaction, and reduced procedure time.

Transitional conic toric intraocular lens for the management of corneal astigmatism in cataract surgery.

SYNOPSIS: Transitional toric intraocular lens (IOL) was developed to improve refractive outcomes in cataract surgery. We report refractive, vectorial outcomes, and stability of spherical equivalent over 12 months after implantation of this IOL. PURPOSE: To evaluate visual and refractive outcomes of a transitional conic toric intraocular lens (IOL) (Precizon®) for the correction of corneal astigmatism in patients undergoing cataract surgery. SETTING: The Ocular Microsurgery Institute (IMO), a private practice in Barcelona, Spain. DESIGN: This is a retrospective, non-randomized study. METHODS: Retrospective chart review of 156 patients with preoperative regular corneal astigmatism >0.75 diopters (D) who underwent consecutive phacoemulsification and Precizon toric IOL implantation between January 2014 and December 2015 was performed. Two groups were divided according to attempted residual refraction: group 1 with emmetropia and group 2 with mild myopia for monovision. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and manifest refraction were analyzed preoperatively and 3, 6, and 12 months postoperatively. RESULTS: Precizon toric IOL was implanted in 97 eyes of 61 patients. Six months postoperatively, none of the eyes lost any line of CDVA. In all, 98% of the eyes were within ±1.00 D of attempted spherical correction. The mean preoperative keratometric cylinder was 1.92 ± 1.04 D (range 0.75-6.78), and the mean postoperative refractive cylinder was 0.77 ± 0.50 D (range 0-2.25), with 81% of the eyes with ≤1.00 D of residual cylinder. Two IOLs required realignment due to intra-operative positioning error. Eleven eyes required enhancement with corneal refractive surgery. CONCLUSION: Preexisting regular corneal astigmatism was effectively and safely corrected by the implantation of the transitional conic toric IOL in patients undergoing cataract surgery.