OBJECTIVES: Patients suffering from cataracts have poor visual acuity that impacts their daily functioning and well-being. Traditional clinical measures such as visual acuity do not capture patients' perceptions of visual functioning and health-related quality of life. This paper focuses on the interim results of a clinical trial examining the impact of cataract removal surgery and IOL implantation on vision targeted QoL. METHODS: The 39-item National Eye Institute- Visual Functioning Questionnaire (NEI-VFQ) consisting of 12 subscales was used to collect QoL data during a US-Investigational Device Exemption (US-IDE) trial comparing the Acrysof(r) Natural single piece IOL with Acrysof(r) single piece IOL. QoL data were collected via trained telephone interviewers once preoperatively (baseline) and twice postoperatively after cataract surgery and IOL implantation (1-2 month, and 4-6 month post-operative visits). RESULTS: Interim analysis results submitted to the US FDA are described here. On a scale of 0-100, overall vision targeted QoL measured as an 11 subscale composite (Overall Vision, Ocular Pain, Near Activities, Distance Activities, Vision Social, Role Difficulties, Mental Health, Dependency, Driving, Color Vision, and Peripheral Vision), improved by over 16 percentage points at the 1-2 month post-operative visit in both treatment groups, and this improvement was sustained at the 4-6 month post-operative visit. Additionally, both treatment groups also showed similar levels of improvements in all the subscale scores, including the color vision subscale. CONCLUSIONS: The study demonstrates that patients receiving bilateral cataract surgery and implantation of Acrysof(r) Natural single piece lens or Acrysof(r) single piece lens had measurable improvement in their vision-targeted QoL and this improvement is sustained.