Cataract
Conditions
Keywords
Cataract, Intraocular lens
Brief summary
The aims of this study are to: * Demonstrate a reduction in postoperative cylinder compared to results from the control lens * Demonstrate better uncorrected distance visual acuity compared to the control lens
Interventions
DEVICETecnis ZCB00 IOL (control)
Tecnis 1-piece acrylic IOL
DEVICEToric Intraocular lens
Toric acrylic intraocular lens with various cylinder powers
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Minimum 18 years of age * Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes * Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye * BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye * Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL) * Clear intraocular media other than cataract in both eyes * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits * Signed informed consent and HIPAA authorization
Exclusion criteria
* Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters * Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye * Previous corneal or intraocular surgery in either eye * Irregular corneal astigmatism in either eye * Corneal pathology/abnormality potentially affecting topography in either eye * Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye * Inability to achieve keratometric stability in either eye for contact lens wearers * Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse * 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 * An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure * Use of systemic or ocular medications that may affect vision * Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure * Poorly-controlled diabetes * Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.) * Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye * Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) * 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 during 30 days prior to preoperative visit in any other clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Reduction in Cylinder | 6 months after second eye implant compared to baseline | Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) | 6 months after second eye implant | Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean. |
Participant flow
Recruitment details
Subjects were enrolled from normal cataract populations at 14 investigative sites.
Pre-assignment details
Subjects with low cylinder were enrolled in a randomized group and received either the control lens or the investigational Toric IOL. Subjects with higher cylinder were enrolled in the high cylinder group and received a higher cylinder investigational Toric IOL.
Participants by arm
| Arm | Count |
|---|---|
| ZCB00 Approved Intraocular control lens | 95 |
| Toric IOL Investigational Toric IOL | 102 |
| Higher Cylinder Toric IOL Investigational toric IOLs with higher cylinder powers. | 72 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Toric IOL | Higher Cylinder Toric IOL | ZCB00 | Total |
|---|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 8 | 69 years STANDARD_DEVIATION 9 | 71 years STANDARD_DEVIATION 9 | 70 years STANDARD_DEVIATION 9 |
| Age, Customized 60 through 69 years | 39 participants | 33 participants | 36 participants | 108 participants |
| Age, Customized <60 years | 10 participants | 7 participants | 5 participants | 22 participants |
| Age, Customized 70 through 79 years | 41 participants | 25 participants | 36 participants | 102 participants |
| Age, Customized >=80 years | 12 participants | 7 participants | 18 participants | 37 participants |
| Region of Enrollment Canada | 8 participants | 6 participants | 8 participants | 22 participants |
| Region of Enrollment United States | 94 participants | 66 participants | 87 participants | 247 participants |
| Sex: Female, Male Female | 55 Participants | 40 Participants | 55 Participants | 150 Participants |
| Sex: Female, Male Male | 47 Participants | 32 Participants | 40 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 174 |
| serious Total, serious adverse events | 0 / 95 | 6 / 174 |
Outcome results
Primary
Mean Percent Reduction in Cylinder
Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.
Time frame: 6 months after second eye implant compared to baseline
Population: Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control IOL | Mean Percent Reduction in Cylinder | 32 percentage of reduction in cylinder | Standard Deviation 79 |
| Toric IOL | Mean Percent Reduction in Cylinder | 75 percentage of reduction in cylinder | Standard Deviation 72 |
| Higher Cylinder Toric IOL | Mean Percent Reduction in Cylinder | 76. percentage of reduction in cylinder | Standard Deviation 33 |
Comparison: Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is \<= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is \> the control. There is 80% power to detect \>=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.p-value: <0.0001t-test, 1 sided
Secondary
Uncorrected Distance Visual Acuity (UCDVA)
Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.
Time frame: 6 months after second eye implant
Population: Available subjects at the final visit with measured uncorrected distance visual acuity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control IOL | Uncorrected Distance Visual Acuity (UCDVA) | 0.16 LogMAR acuity values | Standard Deviation 0.16 |
| Toric IOL | Uncorrected Distance Visual Acuity (UCDVA) | 0.10 LogMAR acuity values | Standard Deviation 0.14 |
| Higher Cylinder Toric IOL | Uncorrected Distance Visual Acuity (UCDVA) | 0.11 LogMAR acuity values | Standard Deviation 0.12 |
Comparison: Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect \>=0.06 LogMAR difference in mean UCDVA between IOL groups.p-value: 0.0009t-test, 1 sided