A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Alcon Research
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
Time Frame: Month 6 (120-180 days post second eye implantation)
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
Time Frame: Month 6 (120-180 days post second eye implantation)
VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Mesopic Contrast Sensitivity
Time Frame: Month 6 (120-180 days post second eye implantation)
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
Time Frame: Month 6 (120-180 days post second eye implantation)
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
Time Frame: Month 6 (120-180 days post second eye implantation)
VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Percentage of Subjects With Ocular Adverse Events
Time Frame: Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
Secondary Outcomes
- Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)(Month 6 (120-180 days post second eye implantation))
- 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?"(Month 6 (120-180 days post second eye implantation))
- Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane(Month 6 (120-180 days post second eye implantation))
- Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane(Month 6 (120-180 days post second eye implantation))
- Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)(Month 6 (120-180 days post second eye implantation))