Back to resultsClinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Primary Purpose
Cataract, Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IC-8 IOL Group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Intraocular lens
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
- Empire Eye & Laser Center
- Harvard Eye Associates
- Altos Eye Physicians
- Advanced Vision Care
- Eye Center of Northern Colorado
- Eye Center of North Florida
- Chu Vision Institute
- Pepose Vision Institute
- Kugler Vision
- Alterman, Modi & Wolter
- Physicians Protocol
- Cleveland Eye Clinic
- Philadelphia Eye Associates
- Bucci Laser Vision
- Vance Thompson Vision
- Baylor College of Medicine
- Parkhurst NuVision
- Hoopes Vision
- Utah Eye Centers
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IC-8 IOL Group
Control Group
Arm Description
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.
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03633695
Brief Title
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Official Title
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcuFocus, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia
Keywords
Cataract, Intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Examiner masked
Allocation
Non-Randomized
Enrollment
453 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC-8 IOL Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.
Intervention Type
Device
Intervention Name(s)
IC-8 IOL Group
Other Intervention Name(s)
Intraocular Lens
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Group
Other Intervention Name(s)
Intraocular lens
Intervention Description
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.
Primary Outcome Measure Information:
Title
Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes
Description
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.
Time Frame
3 Months (60-110 days post second eye operative visit)
Title
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
Description
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.
Time Frame
12 Months (300-420 days post second eye operative visit)
Title
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
Description
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.
Time Frame
12 Months (300-420 days post second eye operative visit)
Title
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
Description
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.
Time Frame
12 Months (300-420 days post second eye operative visit)
Title
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Description
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.
Time Frame
Through 12 Months (300-420 days post second eye operative visit)
Title
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Description
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.
Time Frame
Through 12 Months (300-420 days post second eye operative visit)
Title
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Description
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.
Time Frame
Through 12 Months (300-420 days post second eye operative visit)
Title
Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals
Description
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.
Time Frame
Through 12 Months (300-420 days post second eye operative visit)
Title
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Description
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.
Time Frame
Through 12 Months (300-420 days post second eye operative visit)
Secondary Outcome Measure Information:
Title
Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months
Description
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.
Time Frame
3 Months (60-110 days post second eye operative visit)
Title
Mean Monocular Photopic Contrast Sensitivity Without Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Monocular Photopic Contrast Sensitivity With Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Monocular Mesopic Contrast Sensitivity With Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Binocular Photopic Contrast Sensitivity Without Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Binocular Photopic Contrast Sensitivity With Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
Title
Mean Binocular Mesopic Contrast Sensitivity With Glare
Description
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.
Time Frame
6 Months (160-210 days post second eye operative visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Michna, PhD
Organizational Affiliation
AcuFocus, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Altos Eye Physicians
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
Facility Name
Advanced Vision Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Eye Center of Northern Colorado
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Eye Center of North Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Pepose Vision Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Kugler Vision
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68118
Country
United States
Facility Name
Alterman, Modi & Wolter
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Physicians Protocol
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Bucci Laser Vision
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hoopes Vision
City
Draper
State/Province
Utah
ZIP/Postal Code
84021
Country
United States
Facility Name
Utah Eye Centers
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
We'll reach out to this number within 24 hrs