Clinical Context

Cataracts cause a clouding of the normally clear lens of the eye, leading to reduced vision. This condition can make it difficult for individuals to perform everyday tasks like reading and driving. Cataracts can be surgically removed, resulting in aphakia or the lack of an eye lens. In the same surgery, a clear artificial intraocular lens (IOL) is implanted to replace the eye lens. Presbyopia, the inability to focus on objects up close, can be a new or persistent problem following cataract surgery.

Device Description

AcrySof IQ PanOptix Trifocal IOL (Model TFNT00) (Premarket Approval P040020/S087) is a Class III ultraviolet absorbing and blue light filtering foldable multifocal IOL that can be implanted after cataract removal.

Indications for Use

The Acrysof IQ PanOptix Trifocal Intraocular lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL; see Summary of Safety and Effectiveness Data (PDF).

Context of Clinical Outcome Assessment (COA) Use

Two different patient-reported outcome (PRO) instruments were used to assess endpoints in the pivotal clinical investigation for the AcrySof IQ PanOptix Trifocal IOL: the Questionnaire for Visual Disturbances (QUVID) and the IOL satisfaction questionnaire (IOLSAT). Both PRO instruments were developed by the device sponsor and final fit-for-purpose determination of these instruments was made by CDRH during the PMA review process.

The secondary safety endpoint for the clinical investigation was an estimate of the rates of “severe” and “most bothersome” visual disturbances as reported by patients on the QUVID. This instrument was also used as an ancillary safety endpoint to assess rates of all visual disturbances, not only those that were “severe” and “most bothersome.”

The proportion of subjects responding “never” to the first question of the IOLSAT questionnaire (“Overall, in the past 7 days, how often did you need to wear eyeglasses to see?”) was one of two secondary effectiveness endpoints. The device’s Indications for Use and labeling materials were directly informed by this endpoint, including a statement that the lens maintains “comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL.”

Lessons Learned

This device approval employed careful planning and use of reliable development methods to develop an appropriate PRO instrument in the absence of appropriate tools. Early discussions with CDRH are encouraged and can aid in the development of an application-specific PRO instrument.

PRO instruments can be used to demonstrate both safety and effectiveness of a medical device while capturing concepts important to patients. Notably, this approval illustrated how impactful a PRO instrument can be, specifically on the Indications for Use. This information was also included in the patient labeling materials, which can help inform patients’ decisions to have the lens implanted.