Cataract
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.
Interventions
DEVICETECNIS Symfony Extended Range of Vision IOL, Model ZXR00
DEVICETECNIS Monofocal IOL, Model ZCB00
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Minimum 22 years of age * Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes * Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source * Potential for postoperative BCDVA of 20/30 Snellen or better * Corneal astigmatism * Clear intraocular media, other than cataract * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Signed informed consent and HIPAA authorization * Ability to understand and respond to a questionnaire in English or Spanish
Exclusion criteria
* Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D * Pupil abnormalities * Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject * Prior corneal refractive or intraocular surgery * Corneal abnormalities * Inability to achieve keratometric stability for contact lens wearers * Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study * 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 during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject * Inability to focus or fixate for prolonged periods of time * Poorly-controlled diabetes * Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study. * 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 30 days prior to preoperative visit in any other clinical trial * Desire for monovision correction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Corrected Intermediate Visual Acuity | At 6 months | FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity. |
| Uncorrected Intermediate Visual Acuity | 6 months | Uncorrected Intermediate Visual Acuity at 6 months. |
Countries
United States
Participant flow
Recruitment details
Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.
Pre-assignment details
A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.
Participants by arm
| Arm | Count |
|---|---|
| TECNIS Intraocular Lens, Model ZXR00 Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 | 148 |
| TECNIS Intraocular Lens, Model ZCB00 Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 | 151 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Illness | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | TECNIS Intraocular Lens, Model ZCB00 | TECNIS Intraocular Lens, Model ZXR00 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 66 Participants | 63 Participants | 129 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 85 Participants | 170 Participants |
| Age, Continuous | 67.9 Years STANDARD_DEVIATION 7.9 | 68.0 Years STANDARD_DEVIATION 7.5 | 67.9 Years STANDARD_DEVIATION 7.7 |
| Gender Female | 86 Participants | 91 Participants | 177 Participants |
| Gender Male | 65 Participants | 57 Participants | 122 Participants |
| Region of Enrollment United States | 151 participants | 148 participants | 299 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 148 | 0 / 151 |
| serious Total, serious adverse events | 5 / 148 | 11 / 151 |
Outcome results
Primary
Distance Corrected Intermediate Visual Acuity
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Time frame: At 6 months
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TECNIS Intraocular Lens, Model ZXR00 | Distance Corrected Intermediate Visual Acuity | 0.105 LogMAR | Standard Error 0.009 |
| TECNIS Intraocular Lens, Model ZCB00 | Distance Corrected Intermediate Visual Acuity | 0.343 LogMAR | Standard Error 0.013 |
Primary
Uncorrected Intermediate Visual Acuity
Uncorrected Intermediate Visual Acuity at 6 months.
Time frame: 6 months
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TECNIS Intraocular Lens, Model ZXR00 | Uncorrected Intermediate Visual Acuity | 0.087 LogMAR | Standard Error 0.009 |
| TECNIS Intraocular Lens, Model ZCB00 | Uncorrected Intermediate Visual Acuity | 0.258 LogMAR | Standard Error 0.014 |