Cataract
Conditions
Brief summary
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.
Interventions
DEVICETecnis 1 piece IOL
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
DEVICETecnis Eyhance
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum 22 years of age * Bilateral cataracts for which posterior chamber IOL implantation has been planned * Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source * Potential for postoperative best corrected visual acuity of 20/30 Snellen or better * Corneal astigmatism parameters: * Normal corneal topography and no irregular corneal astigmatism * Postoperative astigmatism can be surgically managed to be less than 1 D in each eye * Clear intraocular media other than cataract in each eye * Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits * 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 in English
Exclusion criteria
* Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study. * Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial * Desire for monovision correction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) | 6 months | the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66) | 6 months | the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups |
Countries
United States
Participant flow
Pre-assignment details
A total of 228 subjects were enrolled and 214 subjects were treated. Of the 214 subjects, 107 were implanted with the test lens and 107 with the control lens. 4 subjects did not complete the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Lens Eyhance IOL, Model DIB00 | 107 |
| Control Lens Monofocal IOL, Model ZCB00 | 107 |
| Total | 214 |
Baseline characteristics
| Characteristic | Test Lens | Control Lens | Total |
|---|---|---|---|
| Age, Customized <60 | 9 Participants | 8 Participants | 17 Participants |
| Age, Customized 60-69 | 47 Participants | 39 Participants | 86 Participants |
| Age, Customized 70-79 | 42 Participants | 51 Participants | 93 Participants |
| Age, Customized >=80 | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 15 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 92 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (including Indian) | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Caucasian | 95 Participants | 98 Participants | 193 Participants |
| Race/Ethnicity, Customized Native Hawaiian/ Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Race | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 66 Participants | 68 Participants | 134 Participants |
| Sex: Female, Male Male | 41 Participants | 39 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 107 | 0 / 107 |
| other Total, other adverse events | 1 / 107 | 0 / 107 |
| serious Total, serious adverse events | 5 / 107 | 4 / 107 |
Outcome results
Primary
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
Time frame: 6 months
Population: The ITT (Intent-to-Treat) population for Monocular Best Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) | -0.017 LogMAR | Standard Deviation 0.09 |
| Control Lens | MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) | -0.029 LogMAR | Standard Deviation 0.116 |
90% CI: [-0.036, 0.011]
Secondary
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups
Time frame: 6 months
Population: The ITT (Intent-to-Treat) population for monocular first-eye distance-corrected intermediate visual acuity at 66cm (DCVA66) include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Lens | MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66) | 0.235 LogMAR | Standard Deviation 0.169 |
| Control Lens | MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66) | 0.348 LogMAR | Standard Deviation 0.158 |
p-value: <0.0001t-test, 1 sided