Clinical Outcomes of  Eyedeal’s PA60AS1 Monofocal Intraocular Lens

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From 2019 to 2021, Xi’an Eyedeal Medical Technology Co., Ltd. conducted a randomized, open-label, parallel-controlled clinical trial of its PA60AS1 hydrophobic acrylic aspheric intraocular lens (IOL) across multiple centers, including the First Affiliated Hospital of Xi’an Jiaotong University in Xi’an, China.

A total of 186 subjects were enrolled in the study. Participants were randomly assigned in a 1:1 ratio to receive either the PA60AS1 IOL (treatment group) or the AcrySof IQ SN60WF IOL from Alcon (control group). Follow-up evaluations were conducted at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after implantation.

Visual Performance:

The PA60AS1 IOL demonstrated effective improvement in postoperative vision among cataract patients. Both the treatment and control groups showed significant improvement in visual acuity (best-corrected distance visual acuity and uncorrected distance visual acuity) from as early as postoperative day 1, compared to the baseline screening period. There were no statistically significant differences in the degree of improvement between the two groups (P > 0.05).

From one week after surgery through the final follow-up, patients in both groups maintained stable visual acuity.

At six months post-surgery, 98.89% of eyes implanted with the PA60AS1 IOL achieved best-corrected distance visual acuity of 4.70 or better.

Safety:

The PA60AS1 hydrophobic acrylic aspheric IOL exhibited a strong safety profile. There were no significant differences in safety indicators between the treatment and control groups. No adverse events related to the surgery or the PA60AS1 IOL were reported in the treatment group.

Patient Experience:

According to the patient satisfaction assessment, 100% of patients rated their satisfaction with both corrected and uncorrected vision as “very satisfied” or “satisfied” at 36 months post-implantation. Additionally, 95% of patients indicated they would choose the Eyedeal IOL again if needed.

Clinical Feedback:

Ophthalmic surgeons shared positive evaluations of the PA60AS1 IOL, stating:

“Firm yet flexible—the haptics provide sufficient support while the optic zone maintains moderate flexibility. The lens can be implanted directly into the capsular bag in one smooth step.”

“Silky-smooth implantation process, excellent postoperative visual acuity, patients are satisfied—the product performs very well.”

Clinical trial outcomes, along with favorable feedback from both doctors and patients, highlight the design strengths of the PA60AS1 IOL. It offers patients a high-quality visual experience and represents a compelling new choice for cataract patients and ophthalmologists alike.