Presbyopia
Conditions
Brief summary
Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Different options are available including: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocal, trifocal and extended depth of focus (EDOF) IOLs. The Vivity Extended Vision IOL is not a multifocal IOL but due to its design, it provides better intermediate and near VA compared to a monofocal IOL.
Detailed description
The study is concerned with the visual performance of the Vivity Extended Vision IOL at distance, intermediate and near when one of the eyes is targeted for emmetropia and the other is targeted for slight myopia. Patients will serve as their own controls with visual performance evaluated against corrected vision with a target of emmetropia in both eyes.
Interventions
DEVICEVivity IOL emmetropia
The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to bilateral emmetropia.
DEVICEVivity IOL monovision
The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to emmetropia in the dominant eye and -0.50 in the non-dominant eye.
Sponsors
Science in Vision
Carolina Eyecare Physicians, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Patients all had same treatment, evaluated postoperatively in two scenarios.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must fulfill the following conditions to qualify for enrollment into the trial 1. Subject is undergoing bilateral lens extraction with intraocular lens implantation. 2. Gender: Males and Females. 3. Age: 50 years and older. 4. Willing and able to provide written informed consent for participation in the study 5. Willing and able to comply with scheduled visits and other study procedures. 6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries 7. Subjects who require an IOL power in the range of +15.0 D to +25.0 D only. 8. Subjects who require a toric IOL up to +3.00 D at the IOL plane (2.06 D corneal plane). 9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion criteria
Subjects with any of the following conditions on the eligibility exam may not be enrolled into the trial. 1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc. 2. Uncontrolled diabetes. 3. Use of any systemic or topical drug known to interfere with visual performance. 4. Contact lens use during the active treatment portion of the trial. 5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. 6. Clinically significant corneal dystrophy 7. History of chronic intraocular inflammation. 8. History of retinal detachment. 9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. 10. Previous intraocular surgery. 11. Previous corneal refractive surgery (i.e. laser-assisted in situ keratomileusis, photorefractive keratectomy, radial keratotomy). 12. Previous keratoplasty 13. Severe dry eye 14. Pupil abnormalities 15. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). 16. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. 17. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Uncorrected Near (40 cm) Visual Acuity | 3 months | The logMAR binocular uncorrected visual acuity at 40 cm will be measured. |
Countries
United States
Participant flow
Pre-assignment details
A total of 33 subjects were enrolled in the study. One was lost to follow up and one experienced a progression of their macular degeneration, leaving 31 subjects for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Overall All study participants received the Vivity IOL in both eyes.
The same group of participants were evaluated twice using two different target refractions:
1. Target refraction plano: the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.
2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
Participants were randomized to which target was evaluated first and there was a 10 minutes break between the 2 evaluations. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Binocular Uncorrected Near (40 cm) Visual Acuity
The logMAR binocular uncorrected visual acuity at 40 cm will be measured.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monovision | Binocular Uncorrected Near (40 cm) Visual Acuity | 0.21 logMAR | Standard Deviation 0.11 |
| Emmetropia | Binocular Uncorrected Near (40 cm) Visual Acuity | 0.39 logMAR | Standard Deviation 0.16 |