Clinical trial NCT03010254: A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Official title: A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 322
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 the ACRYSOF® IQ EDF IOL.

Detailed description: Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
* Diagnosed with cataract in both eyes;
* Planned cataract removal by routine small incision surgery;
* Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
* Preoperative regular astigmatism of less than 1.0 D.

Exclusion Criteria:

* Pregnancy or lactation current or planned during the course of the study;
* History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.

Primary outcomes:
measure: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
timeFrame: Month 3 (70-100 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)
Secondary outcomes:
measure: Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
timeFrame: Month 3 (70-100 days post second eye implantation)
measure: Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
timeFrame: Month 3 (70-100 days post second eye implantation)
measure: Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
timeFrame: Month 3 (70-100 days post second eye implantation)
measure: Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
timeFrame: Month 6 (120-180 days post second eye implantation)
measure: Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"
timeFrame: Month 6 (120-180 days post second eye implantation)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Alcon Investigative Site
state: New South Wales
city: Southport
country: Australia
facility: Alcon Investigative Site
state: Queensland
city: Footscray
country: Australia
facility: Alcon Investigative Site
state: Victoria
city: Hawthorn East
country: Australia
facility: Alcon Investigative Site
state: Victoria
city: Vancouver
country: Canada
facility: Alcon Investigative Site
state: British Columbia
city: Mississauga
country: Canada
facility: Alcon Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Alcon Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Alcon Investigative Site
state: Ontario
city: Boisbriand
country: Canada
facility: Alcon Investigative Site
state: QU
city: Québec
country: Canada
facility: Alcon Investigative Site
state: QU
city: Sant Cugat del Vallès
country: Spain
facility: Alcon Investigative Site
state: BCN
city: Jerez De La Frontera
country: Spain
facility: Alcon Investigative Site
state: Cadiz
city: Barcelona
country: Spain
facility: Alcon Investigative Site
city: Barcelona
country: Spain
facility: Alcon Investigative Site
city: Barcelona
country: Spain
facility: Alcon Investigative Site
city: Madrid
country: Spain
facility: Alcon Investigative Site
city: Valencia
country: Spain
facility: Alcon Investigative Site
city: Dartford
country: United Kingdom
facility: Alcon Investigative Site
state: Kent
city: Essex
country: United Kingdom
facility: Alcon Investigative Site
city: London
country: United Kingdom
facility: Alcon Investigative Site
city: Manchester
country: United Kingdom
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Senior Clinical Manager, GCRA
role: STUDY_DIRECTOR
References:
citation: Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.