Perfluorohexyloctane Ophthalmic Solution in Patients with Dry Eye Disease Undergoing Cataract Surgery: A Prospective...

Dry eye disease (DED) is a common comorbidity in patients undergoing cataract surgery. Perfluorohexyloctane ophthalmic solution (PFHO) forms a protective layer on the tear film surface to reduce evaporation and is approved for treatment of signs and symptoms of DED. Because PFHO has a long ocular surface residence time, it was of interest to assess whether PFHO interfered with preoperative biometry and keratometry measurements to affect postoperative refractive accuracy in patients undergoing cataract surgery. This study evaluated the perioperative use of PFHO in patients undergoing cataract surgery.

This phase 4, multicenter, open-label, single-arm study enrolled patients with DED who were candidates for phacoemulsification with posterior chamber intraocular lens (IOL) implantation. Patients instilled PFHO bilaterally four times daily for 30 days preoperatively and received a second 30-day PFHO treatment approximately 1 month after surgery. The primary endpoint was the mean difference in absolute deviations between the manifest refraction spherical equivalent and predicted refractive error.

Ninety-seven patients were enrolled (mean age: 68.6 years; female: 75.3%). The mean difference in absolute deviations between manifest refraction and predicted refractive error was -0.027 ± 0.167 D (p = 0.1385). The difference in predicted refractive error at baseline versus post-PFHO treatment was within ± 0.3 D for 94.2% of study eyes. More patients had a calculated IOL power within ± 0.50 D of the correct IOL power post-PFHO treatment than pre-PFHO (83.7% vs. 72.1%). Treatment with PFHO significantly improved DED signs and symptoms, including total and central corneal fluorescein staining, eye dryness, and Ocular Surface Disease Index scores, before and after cataract surgery (p < 0.0001 for all). The percentage of patients with best-corrected visual acuity of 20/20 or better was 86.0% at first postsurgical assessment and 91.8% after 30 days of subsequent PFHO treatment. Two adverse events were considered related to treatment (mild eye pruritus and mild noninfectious conjunctivitis).

In patients with DED undergoing cataract surgery, PFHO did not affect the accuracy of preoperative biometry and keratometry measurements or the predicted refractive error. Patients experienced significant reductions in signs and symptoms of DED.

ClinicalTrials.gov identifier, NCT06346340.