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A 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. The primary endpoint was the change from baseline in corneal/conjunctival surface staining. Secondary endpoints included assessments of epithelial alterations, point spread function, ocular surface disease index, conjunctival hyperemia, vision break-up time, ocular symptoms/signs, adverse events, best-corrected visual acuity, intraocular pressure, patient/investigator satisfaction, and procedure time.


SETTING
Ocular microsurgery institute.


DESIGN
Phase IV, open-label, randomized, single-center study in 50 patients undergoing sequential cataract surgery in both eyes.


METHODS
Patients were randomized in a 1:1 ratio to receive intracameral mydriatic-anesthetic (Mydrane/Fydrane, Laboratoires Théa) and anesthetic eye drops or control (topical eye drops only). The other treatment was administered for the second cataract surgery. Assessments were pre- and post-surgery, 12-36 hours (Day 1) and 7 days post-surgery.


RESULTS
Baseline assessments were similar in each group. The difference between Fydrane and control for the change from baseline at Day 1 in corneal and conjunctival surface staining was not statistically significant. For Fydrane, post-operative epithelial alterations were fewer at Day 1 (p<0.005), folliculo-papillary reaction was less frequent (p<0.05), some ocular symptoms were less frequent and milder (p<0.05), length of procedure was shorter (p<0.001), and patient and investigator satisfaction were better (p<0.05). There were few adverse events in both groups.


CONCLUSIONS
Fydrane reduced ocular surface damage by decreasing corneal epithelial and conjunctival toxicity with faster recovery of surface integrity compared to topical eye drops, improved patient and investigator satisfaction, and procedure time.