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.