Cataract
Conditions
Keywords
cataract, monofocal, intraocular lens, acrylic
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).
Detailed description
The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.
Interventions
DEVICEmodified light transmission intraocular lens
violet visible light blocking acrylic intraocular lens
DEVICEmonofocal acrylic intraocular lens
conventional hydrophobic acrylic intraocular lens
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years of age or older * Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned * Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation * Preoperative corneal astigmatism of 1.5 diopters or less
Exclusion criteria
* Use of systemic or ocular medications that may affect vision * Uncontrolled systemic or recurrent ocular disease * Requiring an intraocular lens \<15.0 or \>26.0 diopters * Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates * History of ocular trauma or prior ocular surgery * Known pathology that may affect visual acuity or visual field * Corneal abnormalities * Pupil abnormalities * Capsule or zonular abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Distance Visual Acuity | One year | Snellen Equivalent visual acuity of 20/40 or better |
| Uncorrected Distance Visual Acuity | One Year | Snellen Equivalent of 20/40 or better at one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Sensitivity | 4-6 months | Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. |
| Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent. | One Year | Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit. |
Countries
United States
Participant flow
Recruitment details
250 subjects from normal cataract populations who were undergoing primary phacoemulsification with lens implantation and did not have any other visually significant ocular pathologies were selected at 12 investigation sites across the country
Participants by arm
| Arm | Count |
|---|---|
| ZV9003 Intraocular Lens modified light transmission intraocular lens | 126 |
| ZA9003 Intraocular Lens monofocal acrylic intraocular lens | 124 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Illness | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | ZV9003 Intraocular Lens | ZA9003 Intraocular Lens | Total |
|---|---|---|---|
| Age Continuous | 73.3 years STANDARD_DEVIATION 8 | 71.5 years STANDARD_DEVIATION 8 | 72.4 years STANDARD_DEVIATION 8 |
| Age, Customized <60 years | 4 participants | 8 participants | 12 participants |
| Age, Customized >=80 | 30 participants | 21 participants | 51 participants |
| Age, Customized Between 60 and 69 years | 35 participants | 41 participants | 76 participants |
| Age, Customized Between 70 and 79 years | 57 participants | 54 participants | 111 participants |
| Region of Enrollment United States | 126 participants | 124 participants | 250 participants |
| Sex: Female, Male Female | 78 Participants | 68 Participants | 146 Participants |
| Sex: Female, Male Male | 48 Participants | 56 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 0 / 124 |
| serious Total, serious adverse events | 1 / 126 | 1 / 124 |
Outcome results
Primary
Best Corrected Distance Visual Acuity
Snellen Equivalent visual acuity of 20/40 or better
Time frame: One year
Population: One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZV9003 Intraocular Lens | Best Corrected Distance Visual Acuity | 119 participants |
| ZA9003 Intraocular Lens | Best Corrected Distance Visual Acuity | 120 participants |
Primary
Uncorrected Distance Visual Acuity
Snellen Equivalent of 20/40 or better at one year
Time frame: One Year
Population: One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZV9003 Intraocular Lens | Uncorrected Distance Visual Acuity | 110 participants |
| ZA9003 Intraocular Lens | Uncorrected Distance Visual Acuity | 116 participants |
Secondary
Contrast Sensitivity
Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
Time frame: 4-6 months
Population: Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ZV9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 3.0 cpd | 1.62 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 6.0 cpd | 1.65 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 12.0 cpd | 1.14 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 18.0 cpd | 0.60 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 3.0 cpd | 1.76 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 6.0 cpd | 1.91 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 12.0 cpd | 1.58 log contrast |
| ZV9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 18.0 cpd | 1.09 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 18.0 cpd | 1.14 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 3.0 cpd | 1.62 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 3.0 cpd | 1.74 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 6.0 cpd | 1.63 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 12.0 cpd | 1.59 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 12.0 cpd | 1.17 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Photopic condition at 6.0 cpd | 1.94 log contrast |
| ZA9003 Intraocular Lens | Contrast Sensitivity | Mesopic condition at 18.0 cpd | 0.65 log contrast |
Secondary
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent.
Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.
Time frame: One Year
Population: Two subjects in the ZV9003 group did not complete the one year questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZV9003 Intraocular Lens | Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent. | 112 participants |
| ZA9003 Intraocular Lens | Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent. | 113 participants |