Presbyopia, Pseudophakia
Conditions
Brief summary
This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA
Interventions
DEVICETecnis Synergy IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Sponsors
Science in Vision
Center For Sight
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: 18 years and older. 2. Gender: Males and Females. 3. Uneventful bilateral lens extraction 4. Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December 2021. 5. Willing and able to provide written informed consent for participation in the study. 6. Willing and able to comply with scheduled visit and study examination procedures. 7. At least 3 months postoperative from second eye IOL implantation. 8. Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion criteria
1. Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision. 2. Uncontrolled diabetes. 3. Use of any systemic or topical drug known to interfere with visual performance. 4. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. 5. Clinically significant corneal dystrophy. 6. Irregular astigmatism. 7. History of chronic intraocular inflammation. 8. Previous intraocular surgery. 9. Previous keratoplasty 10. Previous refractive surgery. 11. Severe dry eye 12. Pupil abnormalities 13. Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results. 14. 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. 15. Best-corrected distance visual acuity worse than 20/32 in each eye. 16. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) 17. Abnormal iris 18. Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions | Up to 1 year | Visual acuity measured at 40 cm |
| Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions | Up to 1 year | Visual acuity measured at 40 cm under dim light |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synergy IOL Patients implanted with the Synergy IOL in both eyes.
Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Synergy IOL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 31 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 8 |
| 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 | 7 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 52 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
Visual acuity measured at 40 cm under dim light
Time frame: Up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synergy IOL | Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions | 0.21 logMAR | Standard Deviation 0.12 |
Primary
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
Visual acuity measured at 40 cm
Time frame: Up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synergy IOL | Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions | 0.01 logMAR | Standard Deviation 0.07 |