N/A N=220 Randomized Double-blind Treatment

A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT03274986 ↗

Enrolled (actual)

220

Serious AEs

2.3%

Results posted

Apr 2020

Primary outcome: Primary: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane — 0.148; 0.312 logMAR — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ACRYSOF® IQ Extended Depth of Focus IOL (Device); ACRYSOF® IQ Monofocal IOL (Device); Cataract surgery (Procedure)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane	0.148; 0.312	<0.001 sig
PRIMARY Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane	0.016; -0.036	—
PRIMARY Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve	1.53; 0.99	—
PRIMARY Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better	72.9; 25.2	—
PRIMARY Percentage of Subjects With Ocular Adverse Events	0.9; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Mesopic Contrast Sensitivity	1.506; 1.498; 1.447; 1.482; 1.340; 1.548	—
SECONDARY Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane	0.359; 0.515	<0.001 sig
SECONDARY 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?"	21.6; 3.6	—
SECONDARY Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane	0.136; 0.261	—
SECONDARY Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)	0.117; 0.056	—
SECONDARY Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)	3.8; 2.7; 0.9; 0.9; 0.0; 0.0	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03274986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.