Astigmatism, Cataract
Conditions
Brief summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.
Detailed description
The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye. Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group. The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye. There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye. Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.
Interventions
DEVICETECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens
Sponsors
Abbott Medical Optics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Minimum 22 years of age * Bilateral cataracts * Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism. * 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 or 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 * 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 or is lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Visual Distortions | 6 months | Rate of severe visual distortions based on data from a self administered subject questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of IOL Repositioning Due to IOL Misalignment | 6 months | Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL |
| Percent Change in Cylinder | 6 months | Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))\*100 |
Participant flow
Pre-assignment details
Per SAP there is only one arm. It includes all subjects with ZCT450/525/600 toric IOL in the primary eye.Fellow eye can have the same IOL or a ZCT300/400.
Participants by arm
| Arm | Count |
|---|---|
| Extended Cylinder IOL All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. | 101 |
| Extended Cylinder IOL All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. | 101 |
| Total | 202 |
Baseline characteristics
| Characteristic | Extended Cylinder IOL |
|---|---|
| Age, Continuous | 65.5 Years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 1 / 101 |
| serious Total, serious adverse events | 19 / 101 |
Outcome results
Primary
Rate of Severe Visual Distortions
Rate of severe visual distortions based on data from a self administered subject questionnaire
Time frame: 6 months
Population: All subjects implanted with a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) in at least one eye and a high cylinder or low cylinder toric IOL in the fellow eye.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Cylinder IOL | Rate of Severe Visual Distortions | 3 Participants |
Other Pre-specified
Percent Change in Cylinder
Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))\*100
Time frame: 6 months
Population: All subjects implanted with a ZCT450/525/600 in at least one eye
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Cylinder IOL | Percent Change in Cylinder | 88.36 Percent change | Standard Deviation 21.09 |
Other Pre-specified
Rate of IOL Repositioning Due to IOL Misalignment
Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
Time frame: 6 months
Population: All subjects implanted with a ZCT450/525/600 in at least one eye
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Cylinder IOL | Rate of IOL Repositioning Due to IOL Misalignment | 11 Participants |