Cataract
Conditions
Brief summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference
Interventions
DEVICEnon-toric intraocular lens
TECNIS One-piece Monofocal Model ZCB00
DEVICEtoric intraocular lens
TECNIS One-piece Toric Models ZCT300 or ZCT400
Sponsors
Abbott Medical Optics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum 22 years of age * Bilateral cataracts * Preoperative keratometric cylinder in both eyes * Most appropriate toric IOL model choice (ZCT300 or ZCT400) * Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be: ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL * Clear intraocular media other than cataract in each eye * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits * Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire * Signed informed consent and HIPAA authorization
Exclusion criteria
* Irregular corneal astigmatism * Any corneal pathology/abnormality other than regular corneal astigmatism * Previous corneal surgery * Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes * Any pupil abnormalities * Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects * Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study * Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study * Planned monovision correction * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Visual Distortions | 6 months | The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Toric IOL Experimental (ZCT300, ZCT400) | 214 |
| Non-toric IOL Control (ZCB00) | 151 |
| Total | 365 |
Baseline characteristics
| Characteristic | Non-toric IOL | Total | Toric IOL |
|---|---|---|---|
| Age, Continuous | 69.7 Years STANDARD_DEVIATION 10 | 69.5 Years STANDARD_DEVIATION 9.75 | 69.3 Years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 29 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 141 Participants | 336 Participants | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 28 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 128 Participants | 325 Participants | 197 Participants |
| Sex: Female, Male Female | 82 Participants | 202 Participants | 120 Participants |
| Sex: Female, Male Male | 69 Participants | 163 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 214 | 2 / 151 |
| other Total, other adverse events | 0 / 214 | 1 / 151 |
| serious Total, serious adverse events | 32 / 214 | 16 / 151 |
Outcome results
Primary
Rate of Severe Visual Distortions
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
Time frame: 6 months
Population: All subjects bilaterally implanted with a toric IOL (ZCT300 or ZCT400) and all subjects bilaterally implanted with a control IOL (ZCB00). All subjects who were monocularly implanted with a toric IOL (ZCT300/400) or control were excluded from the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toric IOL | Rate of Severe Visual Distortions | With No severe visual distortion | 189 Participants |
| Toric IOL | Rate of Severe Visual Distortions | With severe visual distortion | 0 Participants |
| Non-toric IOL | Rate of Severe Visual Distortions | With No severe visual distortion | 142 Participants |
| Non-toric IOL | Rate of Severe Visual Distortions | With severe visual distortion | 2 Participants |