CataractNCT03633695

Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

A study testing IC-8 IOL Group in people with Cataract and Presbyopia, run by AcuFocus, Inc. at 21 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication. Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Cataract, Presbyopia
What is being tested?: IC-8 IOL Group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 453 participants
Where: 21 sitesUnited States
Study dates: 4 Dec 2018to 15 Oct 2020
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Minimum 22 years of age;
Able to comprehend and have signed a statement of informed consent;
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
Potential for postoperative BCDVA of 20/25 or better in each eye
Clear intraocular media, other than cataract.

Who cannot join

Requiring an IC-8 intraocular lens outside the available spherical power range
Pharmacologically dilated pupil size less than 6 mm in either eye;
Inability to achieve stable keratometric readings for contact lens wearers
Irregular astigmatism in either eye;
Preoperative corneal astigmatism > 1.50 diopters in either eye
Active or recurrent anterior segment pathology

Show all 14Show fewer

Presence of ocular abnormalities other than cataract as specified in the protocol
Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
Congenital cataracts;
Previous corneal or intraocular surgery
History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
Systemic conditions as specified in the protocol;
Patient is pregnant, plans to become pregnant, or is lactating
Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Empire Eye & Laser Center
Bakersfield, California, 93309
Chu Vision Institute
Bloomington, Minnesota, 55420
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Hoopes Vision
Draper, Utah, 84021
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525
Physicians Protocol
Greensboro, North Carolina, 27408
Baylor College of Medicine
Houston, Texas, 77030
Harvard Eye Associates
Laguna Hills, California, 92653
Altos Eye Physicians
Los Altos, California, 94024
Advanced Vision Care
Los Angeles, California, 90067
Virginia Eye Consultants
Norfolk, Virginia, 23502
Utah Eye Centers
Ogden, Utah, 84403
Kugler Vision
Omaha, Nebraska, 68118
Eye Center of North Florida
Panama City, Florida, 32405
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Alterman, Modi & Wolter
Poughkeepsie, New York, 12603
Parkhurst NuVision
San Antonio, Texas, 78229
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Pepose Vision Institute
St Louis, Missouri, 63128
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
Tucson, Arizona, 85704
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702

Other trials in United States

About this study

Read the detailed description

Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.

Conditions: Cataract, Presbyopia
Being tested: IC-8 IOL Group, Control Group
Keywords: Cataract, Intraocular lens
Medical subject headings: Cataract, Presbyopia

What participants receive

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

IC-8 IOL GroupDevice
Also called Intraocular Lens
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.
Control GroupDevice
Also called Intraocular lens
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.

Study groups in NCT03633695
Study group	Role	What they receive
IC-8 IOL Group	Experimental	A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye. Receives: Device: IC-8 IOL Group
Control Group	Active comparator	A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted. Receives: Device: Control Group

What is being measured

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

Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes
Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes
Depth of focus was performed monocularly in the IC-8™ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus 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.
Measured: 3 Months (60-110 days post second eye operative visit)
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Measured: 12 Months (300-420 days post second eye operative visit)
Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Measured: 12 Months (300-420 days post second eye operative visit)
Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8™ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.
Measured: 12 Months (300-420 days post second eye operative visit)
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
The rates of cumulative ocular serious adverse events (SAEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Measured: Through 12 Months (300-420 days post second eye operative visit)
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Measured: Through 12 Months (300-420 days post second eye operative visit)
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Measured: Through 12 Months (300-420 days post second eye operative visit)
Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals
The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Measured: Through 12 Months (300-420 days post second eye operative visit)
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
The rates of cumulative ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Measured: Through 12 Months (300-420 days post second eye operative visit)

Secondary outcomes (9)

Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months
Uncorrected-distance visual acuity (UCDVA) in IC-8™ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism < 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism.
Measured: 3 Months (60-110 days post second eye operative visit)
Mean Monocular Photopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Mesopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Mesopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Measured: 6 Months (160-210 days post second eye operative visit)

Timeline

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

4 Dec 201815 Oct 2020

First posted16 Aug 2018
Study start4 Dec 2018
Primary completion15 Oct 2020
Study completion15 Oct 2020

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.
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: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 453 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03633695
Sponsor's protocol ID: SAIL-101-UNI
Status last verified: Sep 2022
First submitted: 14 Aug 2018
Last updated: 24 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Vukich J, Thompson V, Yeu E, Wiley WF, Bafna S, Koch DD, Lin L, Michna M. Evaluating the small aperture intraocular lens: depth of focus and the role of refraction and preoperative corneal astigmatism in visual performance. J Cataract Refract Surg. 2024 Nov 1;50(11):1165-1172. doi: 10.1097/j.jcrs.0000000000001524.
PubMed 39075732

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?

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
ClinicalTrials.gov ID: NCT03633695
Acronym / sponsor ID: SAIL-101-UNI
Conditions: Cataract, Presbyopia
Keywords: Cataract, Intraocular lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 453 participants (actual)
Lead sponsor: AcuFocus, Inc.Industry (pharma, biotech, devices)
Study start: 4 Dec 2018 (actual)
Primary completion: 15 Oct 2020 (actual)
Study completion: 15 Oct 2020 (actual)
First posted: 16 Aug 2018 (actual)
Results: Posted 24 Oct 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IC-8 IOL Group	Experimental	Device: IC-8 IOL GroupA monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye.
Control Group	Active comparator	Device: Control GroupA monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Minimum 22 years of age;
Able to comprehend and have signed a statement of informed consent;
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;

Key exclusion criteria (14 listed)

Requiring an IC-8 intraocular lens outside the available spherical power range
Pharmacologically dilated pupil size less than 6 mm in either eye;
Inability to achieve stable keratometric readings for contact lens wearers
Irregular astigmatism in either eye;
Preoperative corneal astigmatism > 1.50 diopters in either eye

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
IC-8 IOL GroupAlso: Intraocular LensA monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.	Device	IC-8 IOL Group
Control GroupAlso: Intraocular lensA monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.	Device	Control Group

Primary outcome

Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
Time frame: 6 Months (160-210 days post second eye operative visit)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
Time frame: 6 Months (160-210 days post second eye operative visit)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
Time frame: 6 Months (160-210 days post second eye operative visit)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes
Time frame: 6 Months (160-210 days post second eye operative visit)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes
Time frame: 3 Months (60-110 days post second eye operative visit)
Depth of focus was performed monocularly in the IC-8™ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus 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.
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
Time frame: 12 Months (300-420 days post second eye operative visit)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Time frame: 12 Months (300-420 days post second eye operative visit)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Time frame: 12 Months (300-420 days post second eye operative visit)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8™ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Time frame: Through 12 Months (300-420 days post second eye operative visit)
The rates of cumulative ocular serious adverse events (SAEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Time frame: Through 12 Months (300-420 days post second eye operative visit)
The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Time frame: Through 12 Months (300-420 days post second eye operative visit)
The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals
Time frame: Through 12 Months (300-420 days post second eye operative visit)
The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Time frame: Through 12 Months (300-420 days post second eye operative visit)
The rates of cumulative ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.

9 secondary outcomes

Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months
Time frame: 3 Months (60-110 days post second eye operative visit)
Mean Monocular Photopic Contrast Sensitivity Without Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Contrast Sensitivity With Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Monocular Mesopic Contrast Sensitivity With Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Contrast Sensitivity Without Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Contrast Sensitivity With Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Time frame: 6 Months (160-210 days post second eye operative visit)
Mean Binocular Mesopic Contrast Sensitivity With Glare
Time frame: 6 Months (160-210 days post second eye operative visit)

Results and safety

Results posted to the registry on 24 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IC-8™ IOL Group	343	331
Control Group	110	101

Primary outcome: Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)

Time frame: 6 Months (160-210 days post second eye operative visit). Mean (Standard Deviation). Unit: logMAR

Measure	IC-8™ IOL Group n = 335	Control Group n = 100
Value	0.051 (0.1629)	0.228 (0.1646)

IC-8™ IOL Group vs Control Group: Mean Difference (Final Values): -0.177 (95% CI -0.214 to -0.140), p <.0001, t-test, 2 sided

Population analysed: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.

Primary outcome: Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)

Time frame: 6 Months (160-210 days post second eye operative visit). Mean (Standard Deviation). Unit: logMAR

Measure	IC-8™ IOL Group n = 335	Control Group n = 100
Value	0.186 (0.1425)	0.377 (0.1576)

IC-8™ IOL Group vs Control Group: Mean Difference (Final Values): -0.191 (95% CI -0.223 to -0.158), p <.0001, t-test, 2 sided

Primary outcome: Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)

Time frame: 6 Months (160-210 days post second eye operative visit). Mean (Standard Deviation). Unit: logMAR

Measure	IC-8™ IOL Group n = 335	Control Group n = 100
Value	-0.010 (0.1063)	0.002 (0.0992)

IC-8™ IOL Group vs Control Group: Mean Difference (Final Values): -0.012, p <.0001, t-test, 1 sided

Primary outcome: Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes

Time frame: 6 Months (160-210 days post second eye operative visit). Mean (Standard Deviation). Unit: logMAR

Measure	IC-8™ IOL Eyes (IC-8™ IOL Group) n = 335	Fellow Eyes (IC-8™ IOL Group) n = 335
Value	0.144 (0.1709)	0.325 (0.1687)

IC-8™ IOL Eyes (IC-8™ IOL Group) vs Fellow Eyes (IC-8™ IOL Group): Mean Difference (Final Values): -0.180 (95% CI -0.198 to -0.163), p <.0001, t-test, 2 sided

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Second eye implantation through study completion; approximately 1-year (12 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative	0 of 453 (0%)	0 of 453 (0%)	0 of 453
IC-8™ IOL Group - 2nd Eye	6 of 343 (1.7%)	264 of 343 (77%)	0 of 343
IC-8™ IOL Group - 1st Eye	2 of 343 (0.6%)	148 of 343 (43.1%)	0 of 343
IC-8™ IOL Group - Systemic	22 of 343 (6.4%)	114 of 343 (33.2%)	0 of 343
Control Group - 2nd Eye	1 of 110 (0.9%)	56 of 110 (50.9%)	0 of 110
Control Group - 1st Eye	1 of 110 (0.9%)	55 of 110 (50%)	0 of 110
Control Group - Systemic	5 of 110 (4.5%)	50 of 110 (45.5%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39075732Vukich J, Thompson V, Yeu E, Wiley WF, Bafna S, Koch DD, Lin L, Michna M. Evaluating the small aperture intraocular lens: depth of focus and the role of refraction and preoperative corneal astigmatism in visual performance. J Cataract Refract Surg. 2024 Nov 1;50(11):1165-1172. doi: 10.1097/j.jcrs.0000000000001524.
Sponsor websiteLink provided by the sponsor.
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.

Magda Michna, PhD study director

AcuFocus, Inc.

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IC-8 IOL Group in people with Cataract and Presbyopia, run by AcuFocus, Inc. at 21 sites in United States.

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 7 inclusion and 14 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 24 Oct 2022. 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 United States. 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 24 Oct 2022). 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?

Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA) (time frame: 6 Months (160-210 days post second eye operative visit)). The study lists 13 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 NCT03633695, 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 24 Oct 2022.