Classification Of Severity Of Visual Symptoms In Patients Implanted With The Tecnis Eyhance Intraocular Lens

Develop a method to quantify the severity of visual symptoms following bilateral implantation with Tecnis Eyhance IOL

Multi-center clinical trial at 9 sites across Europe

This was a  prospective randomized masked clinical trial. 151 subjects were enrolled. The Patient Reported Visual Symptoms Questionnaire (PRVSQ) was used to evaluate visual symptoms at 6 months. The PRVSQ evaluated 7 items (including Halos, Glare, and Starbursts) and the response categories include frequency (Never, Rarely, Sometimes, Often, Always), bothersome (Not at all, Slightly, Moderately, Very, Extremely), and difficulty (Not at all, Yes). A dichotomous score (0 or 1) was applied to the PRVSQ to quantify the severity of symptoms. The patient was considered to have severe symptom (1) when frequency was marked as rarely, sometimes, often, or always, AND bothersome was marked as very or extremely, AND difficulty was marked as yes. 

A total of 140 subjects bilaterally implanted with Tecnis monofocal, ZCB00 (n=72) and Eyhance, ICB00 (n=67) were available for analysis. The dichotomous scoring system was applied to the PRVSQ halo, glare and starburst results. A score of 0 was considered to have no severe symptoms and 1 was considered to have severe symptoms. For halo, 98.5% (66/67) in the ICB00 group and 95.8% (69/72) in the ZCB00 group scored a 0. For glare, 95.5% (64/67) in the ICB00 group and 94.4% (68/72) in the ZCB00 group scored a 0. For starburst, 98.5% (66/67) in the ICB00 group and 95.8% (69/72) in the ZCB00 group scored a 0.

The scoring system provided a method to quantify the visual symptom responses from the PRVSQ. Subjects implanted with the enhanced monofocal IOL, TECNIS Eyhance, Model ICB00 experienced low rates of severe visual symptoms comparable to the standard TECNIS monofocal, Model ZCB00.