Cataract
Conditions
Brief summary
This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL. The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.
Interventions
DEVICEInvestigational Intraocular Lens Device #1: TECNIS Model ZHR00
Intraocular lens replaces the natural lens removed during cataract surgery.
DEVICEInvestigational Intraocular Lens Device #2: TECNIS Model ZQR00
Intraocular lens replaces the natural lens removed during cataract surgery.
DEVICETECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intraocular lens replaces the natural lens removed during cataract surgery.
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
subject/evaluator-masked
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bilateral cataracts * Potential for postoperative BCDVA of 20/30 Snellen or better * Corneal astigmatism of 1.00 D or less in both eyes * Normal corneal topography * Clear intraocular media other than cataract in each eye * Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Exclusion criteria
* Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils) * Irregular corneal astigmatism * Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery * Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study * Inability to achieve keratometric stability for contact lens wearers * Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject * Subjects with diagnosed degenerative visual disorders * Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects * Use of systemic or ocular medications that may affect vision * Prior, current, or anticipated use of tamsulosin or silodosin * Poorly-controlled diabetes * Acute, chronic, or uncontrolled systemic or ocular disease or illness * Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study * Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes * Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial * Desire for monovision correction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 1 month postoperative | The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative |
| Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | 6 months postoperative | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. |
| Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | 6 months postoperative | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. |
Countries
United States
Participant flow
Pre-assignment details
A total of 242 subjects were enrolled in this study, and 229 subjects were implanted with study IOL in first eye.
Participants by arm
| Arm | Count |
|---|---|
| Tecnis ZHR00 Investigational Lens Device | 77 |
| Tecnis ZQR00 Investigational Lens Device | 73 |
| Tecnis ZXR00 Control Lens Device | 79 |
| Total | 229 |
Baseline characteristics
| Characteristic | Tecnis ZHR00 | Total | Tecnis ZXR00 | Tecnis ZQR00 |
|---|---|---|---|---|
| Age, Customized 60-69 years | 37 Participants | 115 Participants | 44 Participants | 34 Participants |
| Age, Customized 70-79 years | 29 Participants | 80 Participants | 27 Participants | 24 Participants |
| Age, Customized Greater than or equal to >= 80 years | 1 Participants | 6 Participants | 1 Participants | 4 Participants |
| Age, Customized Les than < 60 years | 10 Participants | 28 Participants | 7 Participants | 11 Participants |
| Age, Customized Not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 224 Participants | 77 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (including Indian) | 3 Participants | 6 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 9 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 71 Participants | 213 Participants | 73 Participants | 69 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 48 Participants | 141 Participants | 46 Participants | 47 Participants |
| Sex: Female, Male Male | 29 Participants | 88 Participants | 33 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 78 | 0 / 73 | 1 / 79 |
| other Total, other adverse events | 4 / 78 | 3 / 73 | 3 / 79 |
| serious Total, serious adverse events | 8 / 78 | 7 / 73 | 5 / 79 |
Outcome results
Primary
Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative
Time frame: 1 month postoperative
Population: The safety population (SP) of all subjects implanted who have available data will be used for all analysis. For the monocular endpoints, the safety population will consist of first eyes implanted with a study IOL.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tecnis ZHR00 | Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.136 LogMAR | Standard Deviation 0.12 |
| Tecnis ZQR00 | Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.141 LogMAR | Standard Deviation 0.149 |
| Tecnis ZXR00 | Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.276 LogMAR | Standard Deviation 0.116 |
Primary
Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.
Time frame: 6 months postoperative
Population: Statistical comparisons to ISO SPE rates are based on first-eye data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tecnis ZHR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Iritis | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Raised IOP requiring treatment | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Cystoid macular edema | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Corneal edema | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Corneal edema | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Cystoid macular edema | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Raised IOP requiring treatment | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Iritis | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Raised IOP requiring treatment | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Corneal edema | 1.3 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Cystoid macular edema | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Iritis | 0.0 Percent |
p-value: 0.02041Exact test on binomial distribution
Primary
Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)
Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.
Time frame: 6 months postoperative
Population: Statistical comparisons to ISO SPE rates are based on first-eye data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Hypopyon | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Pupillary block | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Lens dislocated from posterior chamber | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Cystoid Macular Edema | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Eyes with secondary surgical intervention | 1.3 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Retinal detachment | 0.0 Percent |
| Tecnis ZHR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Endolphthalmitis | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Lens dislocated from posterior chamber | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Cystoid Macular Edema | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Hypopyon | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Endolphthalmitis | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Pupillary block | 0.0 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Retinal detachment | 1.4 Percent |
| Tecnis ZQR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Eyes with secondary surgical intervention | 4.1 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Pupillary block | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Hypopyon | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Eyes with secondary surgical intervention | 1.3 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Retinal detachment | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Lens dislocated from posterior chamber | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Endolphthalmitis | 0.0 Percent |
| Tecnis ZXR00 | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Cystoid Macular Edema | 1.3 Percent |
p-value: 0.1969Exact test on binomial distribution
p-value: 0.4655Exact test of binomial distribution
p-value: 0.021Exact test on binomial distribution
p-value: 0.4698Exact test on binomial distribution