Clinical trial NCT03274986: A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)
Official title: A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-09-07
Enrollment: 242
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.

Detailed description: Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Eligibility criteria: Inclusion Criteria:

* Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester)
* Preoperative regular astigmatism of \< 1.0 D in both eyes
* Clear intraocular media other than cataract
* Diagnosed with cataract in both eyes
* Planned cataract removal by routine small incision surgery
* Calculated lens power between 18.0 and 25.0 diopter (D) \[when targeted for emmetropia (0.0 D)\]
* Willing and able to complete all required postoperative visits
* Able to comprehend and sign an ethics committee-approved statement of informed consent
* Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.

Exclusion Criteria:

* History of eye pathology and/or inflammation, as specified in the protocol
* Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion
* History of previous intraocular or corneal surgery
* Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes
* Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.

Primary outcomes:
measure: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Percentage of Subjects With Ocular Adverse Events
timeFrame: Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)
measure: Mesopic Contrast Sensitivity
timeFrame: Month 6 (120-180 days post second eye implantation)
Secondary outcomes:
measure: Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
timeFrame: Month 6 (120-180 days post second eye implantation)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alcon Investigative Site
state: Alabama
city: Fort Collins
country: United States
facility: Alcon Investigative Site
state: Colorado
city: Bradenton
country: United States
facility: Alcon Investigative Site
state: Florida
city: Sebring
country: United States
facility: Alcon Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Alcon Investigative Site
state: Georgia
city: Rock Island
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Cincinnati
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Allenwood
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: Kingston
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: West Mifflin
country: United States
facility: Alcon Investigative Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Alcon Investigative Site
state: South Dakota
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References:
citation: McCabe C, Berdahl J, Reiser H, Newsom TH, Cibik L, Koch D, Lemp-Hull J, Jasti S. Clinical outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive design. J Cataract Refract Surg. 2022 Nov 1;48(11):1297-1304. doi: 10.1097/j.jcrs.0000000000000978. Epub 2022 May 26.