CataractNCT03010254

A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

A study testing ACRYSOF® IQ Extended Depth of Focus IOL, ACRYSOF® IQ Monofocal IOL and Cataract surgery in people with Cataract, run by Alcon Research at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: ACRYSOF® IQ Extended Depth of Focus IOL, ACRYSOF® IQ Monofocal IOL and Cataract surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 322 participants
Where: 21 sitesin 4 countries
Study dates: 21 Mar 2017to 31 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

21 sites in 4 countries.

Country

City, postcode or hospital

21 sites in 4 countries

Spain7 sites

Alcon Investigative Site
Barcelona, 08008
Alcon Investigative Site
Barcelona, 08021
Alcon Investigative Site
Barcelona, 08022
Alcon Investigative Site
Jerez de la Frontera, Cadiz, 11408
Alcon Investigative Site
Madrid, 28003
Alcon Investigative Site
Sant Cugat del Vallès, BCN, 08195
Alcon Investigative Site
Valencia, 46015

Other trials in Spain

Canada6 sites

Alcon Investigative Site
Boisbriand, QU, J7H 186
Alcon Investigative Site
Mississauga, Ontario, L5L1W8
Alcon Investigative Site
Québec, QU, G1S 4L8
Alcon Investigative Site
Toronto, Ontario, M3N 2V7
Alcon Investigative Site
Toronto, Ontario, M5T 3A9
Alcon Investigative Site
Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

Australia4 sites

Alcon Investigative Site
Footscray, Victoria, 3011
Alcon Investigative Site
Hawthorn East, Victoria, 3123
Alcon Investigative Site
Southport, Queensland, 4215
Alcon Investigative Site
Sydney, New South Wales, 2150

Other trials in Australia

United Kingdom4 sites

Alcon Investigative Site
Dartford, Kent, DA2 8DA
Alcon Investigative Site
Essex, SS0 9AG
Alcon Investigative Site
London, NW1 5QH
Alcon Investigative Site
Manchester, M13 9WL

Other trials in United Kingdom

About this study

Official title: A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL

The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.

Read the 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.

Conditions: Cataract
Being tested: ACRYSOF® IQ Extended Depth of Focus IOL, ACRYSOF® IQ Monofocal IOL, Cataract surgery
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACRYSOF® IQ Extended Depth of Focus IOLDevice
Also called Model DFT015
Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject
ACRYSOF® IQ Monofocal IOLDevice
Also called Model SN60WF
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
Cataract surgeryProcedure or surgery
IOL bilateral implantation

Study groups in NCT03010254
Study group	Role	What they receive
DFT015	Experimental	ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation Receives: Device: ACRYSOF® IQ Extended Depth of Focus IOL; Procedure: Cataract surgery
SN60WF	Active comparator	ACRYSOF® IQ Monofocal IOL, bilateral implantation Receives: Device: ACRYSOF® IQ Monofocal IOL; Procedure: Cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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.
Measured: Month 3 (70-100 days post second eye implantation)
Percentage of Subjects With Ocular Adverse Events
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 by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
Measured: Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)

Secondary outcomes (6)

Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, 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.
Measured: Month 3 (70-100 days post second eye implantation)
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. 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.
Measured: Month 3 (70-100 days post second eye implantation)
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. 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. 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.
Measured: Month 3 (70-100 days post second eye implantation)
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
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 feet (2.45 m) from the eye at a spatial frequency of 12 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.
Measured: Month 6 (120-180 days post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
Measured: Month 6 (120-180 days post second eye implantation)
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)?"
No formal statistical hypothesis testing was planned.
Measured: Month 6 (120-180 days post second eye implantation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201731 Oct 2018

First posted5 Jan 2017 (estimated)
Study start21 Mar 2017
Primary completion17 Aug 2018
Study completion31 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 322 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03010254
Sponsor's protocol ID: ILI875-C001
Status last verified: Mar 2020
First submitted: 3 Jan 2017
Last updated: 7 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34288635

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
ClinicalTrials.gov ID: NCT03010254
Acronym / sponsor ID: ILI875-C001
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 322 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 21 Mar 2017 (actual)
Primary completion: 17 Aug 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 5 Jan 2017 (estimated)
Results: Posted 7 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DFT015	Experimental	Device: ACRYSOF® IQ Extended Depth of Focus IOL, Procedure: Cataract surgeryACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
SN60WF	Active comparator	Device: ACRYSOF® IQ Monofocal IOL, Procedure: Cataract surgeryACRYSOF® IQ Monofocal IOL, bilateral implantation

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACRYSOF® IQ Extended Depth of Focus IOLAlso: Model DFT015Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject	Device	DFT015
ACRYSOF® IQ Monofocal IOLAlso: Model SN60WFMonofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject	Device	SN60WF
Cataract surgeryIOL bilateral implantation	Procedure or surgery	DFT015, SN60WF

Primary outcome

Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
Time frame: Month 3 (70-100 days post second eye implantation)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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 by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.

6 secondary outcomes

Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
Time frame: Month 3 (70-100 days post second eye implantation)
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Time frame: Month 3 (70-100 days post second eye implantation)
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Time frame: Month 3 (70-100 days post second eye implantation)
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
Time frame: Month 6 (120-180 days post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Time frame: Month 6 (120-180 days post second eye implantation)
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)?"
Time frame: Month 6 (120-180 days post second eye implantation)

Results and safety

Results posted to the registry on 7 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DFT015	159	152
SN60WF	123	118

Primary outcome: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)

Time frame: Month 3 (70-100 days post second eye implantation). Least squares mean (Standard Error). Unit: logMAR

Measure	DFT015 n = 153	SN60WF n = 115
Value	0.175 (0.0137)	0.313 (0.0158)

DFT015 vs SN60WF: Least Squares Mean Difference: -0.138 (95% CI -0.180 to -0.097), p <0.001, t-test, 2 sided

Population analysed: All-Implanted Analysis Set

Primary outcome: 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). Number. Unit: percentage of subjects

Measure	DFT015 First Eye n = 156	DFT015 Second Eye n = 154
Cumulative: Cystoid macular oedema	0.6	0.0
Cumulative: Hypopyon	0.0	0.0
Cumulative: Endophthalmitis	0.0	0.0
Cumulative: Lens dislocated from posterior chamber	0.0	0.0
Cumulative: Pupillary block	0.0	0.0
Cumulative: Retinal detachment	0.0	0.0
Cumulative: Secondary surgical intervention	0.6	0.6
Persistent: Corneal stroma oedema	0.0	0.0

Population analysed: This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative	1 of 276 (0.4%)	0 of 276 (0%)	0 of 276
DFT015 First Eye	2 of 156 (1.3%)	0 of 156 (0%)	0 of 156
DFT015 Second Eye	2 of 154 (1.3%)	0 of 154 (0%)	0 of 154
DFT015 Systemic	3 of 156 (1.9%)	0 of 156 (0%)	0 of 156
SN60WF First Eye	2 of 120 (1.7%)	0 of 120 (0%)	0 of 120
SN60WF Second Eye	0 of 119 (0%)	0 of 119 (0%)	0 of 119
SN60WF Systemic	9 of 120 (7.5%)	0 of 120 (0%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34288635Bala 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Senior Clinical Manager, GCRA study director

Alcon Research

21 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACRYSOF® IQ Extended Depth of Focus IOL, ACRYSOF® IQ Monofocal IOL and Cataract surgery in people with Cataract, run by Alcon Research at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain, Canada, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm) (time frame: Month 3 (70-100 days post second eye implantation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03010254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.