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

NCT03633695 | Completed Results FDA Device

• 1 other identifier: SAIL-101-UNI
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Cataract; Presbyopia

Keywords

Cataract; Intraocular lens

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  3 Months (60-110 days post second eye operative visit)

• Mean Monocular Photopic Contrast Sensitivity Without Glare

  6 Months (160-210 days post second eye operative visit)

• Mean Monocular Photopic Contrast Sensitivity With Glare

  6 Months (160-210 days post second eye operative visit)

• Mean Monocular Mesopic Contrast Sensitivity Without Glare

  6 Months (160-210 days post second eye operative visit)

• Mean Monocular Mesopic Contrast Sensitivity With Glare

  6 Months (160-210 days post second eye operative visit)

Study Arms (2)

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.

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.

Device: Control Group

Interventions

IC-8 IOL Group DEVICE

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.

Also known as: Intraocular Lens

IC-8 IOL Group

Control Group DEVICE

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.

Also known as: Intraocular lens

Control Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AcuFocus, Inc.: lead

Study Sites (21)

Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center

Tucson, Arizona, 85704, United States

Location

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Altos Eye Physicians

Los Altos, California, 94024, United States

Location

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Eye Center of Northern Colorado

Fort Collins, Colorado, 80525, United States

Location

Eye Center of North Florida

Panama City, Florida, 32405, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Pepose Vision Institute

St Louis, Missouri, 63128, United States

Location

Kugler Vision

Omaha, Nebraska, 68118, United States

Location

Alterman, Modi & Wolter

Poughkeepsie, New York, 12603, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27408, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Philadelphia Eye Associates

Philadelphia, Pennsylvania, 19148, United States

Location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Hoopes Vision

Draper, Utah, 84021, United States

Location

Utah Eye Centers

Ogden, Utah, 84403, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• 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.

  PMID: 39075732 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Cataract; Presbyopia

Interventions

Lenses, Intraocular; Control Groups

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Magda Michna, PhD., Chief Global Clinical, Medical and Regulatory Affairs Officer
• Organization: AcuFocus, Inc.

mmichna@acufocus.com

(949) 585-9511

Study Officials

• Magda Michna, PhD

  AcuFocus, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Examiner masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: December 4, 2018
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: October 24, 2022
• Results First Posted: October 24, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)