Cataract
Conditions
Brief summary
The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.
Interventions
DEVICESymfony IOL
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
DEVICEVivity IOL
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Sponsors
Science in Vision
Carolina Eyecare Physicians, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU. 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 in both eyes, with 1 to 30 days between surgeries. 7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion criteria
1. Severe preoperative ocular pathology 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. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities. 8. History of chronic intraocular inflammation. 9. History of retinal detachment. 10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. 11. Previous intraocular surgery. 12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK). 13. Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos) 14. Previous keratoplasty 15. Severe dry eye 16. Pupil abnormalities 17. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK) 18. 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. 19. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. | 3 months after surgery | logMAR visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. | 3 months after surgery | — |
| Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions | 3 months after surgery | Visual acuity measured at 4 m |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symfony Optiblue IOL The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. | 32 |
| Clareon Vivity IOL The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Clareon Vivity IOL | Total | Symfony Optiblue IOL |
|---|---|---|---|
| Age, Continuous | 70.16 years STANDARD_DEVIATION 5.62 | 70.17 years STANDARD_DEVIATION 6.31 | 70.18 years STANDARD_DEVIATION 7.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 52 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 17 Participants | 34 Participants | 17 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 Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.
logMAR visual acuity
Time frame: 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symfony Optiblue IOL | Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. | 0.27 logMAR | Standard Deviation 0.17 |
| Clareon Vivity IOL | Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. | 0.32 logMAR | Standard Deviation 0.11 |
Secondary
Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.
Time frame: 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symfony Optiblue IOL | Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. | 0.54 logMAR | Standard Deviation 0.15 |
| Clareon Vivity IOL | Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. | 0.52 logMAR | Standard Deviation 0.12 |
Secondary
Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions
Visual acuity measured at 4 m
Time frame: 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symfony Optiblue IOL | Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions | 0.44 logMAR | Standard Deviation 0.1 |
| Clareon Vivity IOL | Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions | 0.43 logMAR | Standard Deviation 0.1 |