Cataract
Conditions
Keywords
cataract, tecnis, multifocal, intraocular lens
Brief summary
To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.
Detailed description
The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.
Interventions
DEVICETecnis ZM900 Multifocal Intraocular Lens
Investigational intraocular lens
DEVICECeeOn 911A monofocal IOL
Monofocal Control IOL
Sponsors
Abbott Medical Optics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Visual potential of 20/30 or better in each study eye * Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium) * Naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for each study eye * Preoperative corneal astigmatism of 1.0 D or less
Exclusion criteria
* Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated) * Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.) * Uncontrolled systemic or ocular disease * History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention * Presence of ocular pathology other than cataract such as: * Amblyopia or strabismus * Corneal abnormalities * Pupil abnormalities * Capsule or zonule abnormalities * Intraocular inflammation * Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration) * Requiring an intraocular lens outside the study diopter range * Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. | One year | Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject. |
| Mean Binocular Distance Corrected Near Visual Acuity in Snellen | One year | Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units. |
Participant flow
Recruitment details
Multifocal and monofocal control subjects were enrolled in the original study in 2004-2005 from the normal cataract populations at 13 USA sites. In the expansion study, additional multifocal subjects were enrolled from the normal cataract populations at 16 USA sites (13 who also participated in the original study) in 2007.
Pre-assignment details
Subjects chose which type of lens to receive (multifocal or monofocal) in the original study. Subjects only received the multifocal lens in the expansion study.
Participants by arm
| Arm | Count |
|---|---|
| Tecnis Multifocal Subjects Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. | 347 |
| Monofocal Control Subjects Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints. | 123 |
| Total | 470 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 6 |
Baseline characteristics
| Characteristic | Monofocal Control Subjects | Tecnis Multifocal Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 96 Participants | 203 Participants | 299 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 144 Participants | 171 Participants |
| Age, Continuous | 68.7 years STANDARD_DEVIATION 8.9 | 65.9 years STANDARD_DEVIATION 9.5 | 66.7 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 123 participants | 347 participants | 470 participants |
| Sex: Female, Male Female | 81 Participants | 211 Participants | 292 Participants |
| Sex: Female, Male Male | 42 Participants | 136 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 348 | 0 / 123 |
| serious Total, serious adverse events | 14 / 348 | 1 / 123 |
Outcome results
Primary
Mean Binocular Distance Corrected Near Visual Acuity in Snellen
Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
Time frame: One year
Population: Binocular subjects at one year available for testing for both studies combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tecnis Multifocal Subjects | Mean Binocular Distance Corrected Near Visual Acuity in Snellen | 24 Mean Snellen Line (with ETDRS line SD) | Standard Deviation 1.09 |
| Monofocal Control Subjects | Mean Binocular Distance Corrected Near Visual Acuity in Snellen | 70 Mean Snellen Line (with ETDRS line SD) | Standard Deviation 1.64 |
Comparison: ETDRS line scores used for statistical comparisons with mean Snellen values reported above.p-value: <0.0001t-test, 2 sided
Primary
Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject.
Time frame: One year
Population: First eye results from subjects at one year in both the original study and the expansion study combined.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tecnis Multifocal Subjects | Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. | 329 Participants (First Eyes only) |
| Monofocal Control Subjects | Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. | 114 Participants (First Eyes only) |