Cataract
Conditions
Keywords
cataract, IOL, intraocular lens
Brief summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
Interventions
DEVICETecnis Multifocal Intraocular Lens
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
* Minimum 18 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 or worse (Snellen) with or without a glare source * Potential for postoperative best-corrected visual acuity of 20/25 or better * Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular 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 or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries * Ability to understand and respond to a questionnaire verbally administered in English
Exclusion criteria
* Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D * Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) * Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes * Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery * Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study * Inability to achieve keratometric stability for contact lens wearers * Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 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, including 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 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery * Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * 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 outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable. * Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other 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 within 30 days prior to preoperative visit in any other clinical trial * Desire for monovision correction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | six months | Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diopter Range With VA of 20/40 or Better | six months | Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\*) to reach the 6-month visit were included in the substudy. \* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively. |
| Spectacle Independence | six months | Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tecnis Multifocal Intraocular Lens #1 A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens | 147 |
| Tecnis Multifocal Intraocular Lens #2 A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens | 150 |
| Monofocal Intraocular Lens Commercially available monofocal intraocular lens (IOL)
Monofocal Intraocular Lens | 148 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discontinued | 1 | 0 | 2 |
| Overall Study | Missed 6-month exam | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Tecnis Multifocal Intraocular Lens #1 | Tecnis Multifocal Intraocular Lens #2 | Monofocal Intraocular Lens |
|---|---|---|---|---|
| Age, Customized 60 - 69 years | 193 participants | 58 participants | 68 participants | 67 participants |
| Age, Customized 70 - 79 years | 185 participants | 66 participants | 59 participants | 60 participants |
| Age, Customized Greater than or equal to 80 years | 15 participants | 2 participants | 5 participants | 8 participants |
| Age, Customized Less than 60 years | 52 participants | 21 participants | 18 participants | 13 participants |
| Age, Customized Not reported | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United Kingdom | 2 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 443 participants | 146 participants | 150 participants | 147 participants |
| Sex: Female, Male Female | 260 Participants | 74 Participants | 101 Participants | 85 Participants |
| Sex: Female, Male Male | 185 Participants | 73 Participants | 49 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 147 | 0 / 150 | 0 / 148 |
| serious Total, serious adverse events | 2 / 147 | 8 / 150 | 3 / 148 |
Outcome results
Primary
Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
Time frame: six months
Population: eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tecnis Multifocal Intraocular Lens #1 | Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | 0.253 LogMAR VA | Standard Deviation 0.012 |
| Tecnis Multifocal Intraocular Lens #2 | Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | 0.179 LogMAR VA | Standard Deviation 0.011 |
| Monofocal Intraocular Lens | Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | 0.582 LogMAR VA | Standard Deviation 0.014 |
Secondary
Mean Diopter Range With VA of 20/40 or Better
Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\*) to reach the 6-month visit were included in the substudy. \* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.
Time frame: six months
Population: eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tecnis Multifocal Intraocular Lens #1 | Mean Diopter Range With VA of 20/40 or Better | 3.16 diopters | Standard Deviation 0.5 |
| Tecnis Multifocal Intraocular Lens #2 | Mean Diopter Range With VA of 20/40 or Better | 3.30 diopters | Standard Deviation 0.69 |
| Monofocal Intraocular Lens | Mean Diopter Range With VA of 20/40 or Better | 1.75 diopters | Standard Deviation 0.7 |
Secondary
Spectacle Independence
Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.
Time frame: six months
Population: Five subjects (3 from Group #1 \[145-142\], 1 from Group #2 \[150-149\], and 1 from the monofocal control group \[146-145\]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tecnis Multifocal Intraocular Lens #1 | Spectacle Independence | 87 participants |
| Tecnis Multifocal Intraocular Lens #2 | Spectacle Independence | 111 participants |
| Monofocal Intraocular Lens | Spectacle Independence | 3 participants |