Bilateral Cataract, 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. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study that evaluated the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.
Interventions
DEVICESymfony & Synergy IOL combination
The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Sponsors
Science in Vision
Center For Sight
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is undergoing bilateral lens extraction with intraocular lens implantation of the Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye. 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 2 to 30 days between surgeries 7. Subjects who require an IOL power in the range of +5.00 D to +34.0 D only. 8. Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane). 9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion criteria
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. LASIK, photorefractive keratectomy, radial keratotomy). 12. Previous keratoplasty 13. Severe dry eye 14. Pupil abnormalities 15. Anesthesia other than topical or peribulbar 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular Defocus Curve | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Questionnaire | 3 months | Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed |
| Spectacle Independence for Near Activities Questionnaire | 3 months | Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symfony & Synergy IOL Combination Symfony & Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Symfony & Synergy IOL Combination |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 6.3 |
| 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 | 37 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Binocular Defocus Curve
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | +0.50 D | -0.05 logMAR | Standard Deviation 0.08 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | 0.00 D | -0.08 logMAR | Standard Deviation 0.12 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | -0.50 D | -0.05 logMAR | Standard Deviation 0.09 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | -1.00 D | -0.04 logMAR | Standard Deviation 0.1 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | -1.50 D | -0.03 logMAR | Standard Deviation 0.13 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | -2.00 D | 0.04 logMAR | Standard Deviation 0.13 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | -2.50 D | 0.07 logMAR | Standard Deviation 0.14 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | -3.00 D | 0.14 logMAR | Standard Deviation 0.14 |
| Symfony & Synergy IOL Combination | Binocular Defocus Curve | +1.00 D | 0.07 logMAR | Standard Deviation 0.1 |
Secondary
Patient Satisfaction Questionnaire
Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Symfony & Synergy IOL Combination | Patient Satisfaction Questionnaire | 31 Participants |
Secondary
Spectacle Independence for Near Activities Questionnaire
Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Symfony & Synergy IOL Combination | Spectacle Independence for Near Activities Questionnaire | 4 Participants |