Cataract Bilateral, 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, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate 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.
Interventions
DEVICETecnis ZLB00 & Symfony IOL
The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Sponsors
Science in Vision
Johnson & Johnson Surgical Vision, Inc.
Carolina Eyecare Physicians, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is undergoing bilateral cataract extraction with intraocular lens implantation. 2. Willing and able to provide written informed consent for participation in the study 3. Willing and able to comply with scheduled visits and other study procedures. 4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries. 5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only. 6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion criteria
1. Contraindication for a presbyopia correcting IOL. 2. Subjects with severe astigmatism in the non-dominant eye 3. Uncontrolled diabetes. 4. Use of any systemic or topical drug known to interfere with visual performance. 5. Contact lens use during the active treatment portion of the trial. 6. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. 7. Clinically significant corneal dystrophy 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 refractive surgery. 13. Previous keratoplasty 14. Severe dry eye 15. Pupil abnormalities 16. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK) 17. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). 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 Uncorrected Near (40 cm) Visual Acuity. | 3 months | Visual acuity measured at 40 cm without wearing any correction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Visual Satisfaction After Cataract Surgery: Questionnaire | 3 months | Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision. Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied. |
| Spectacle Independence: Questionnaire | 3 months | Patient's spectacle independence was assessed using the Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No. |
| Number of Participants With Visual Symptoms | 3 months | Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tecnis ZLB00 & Symfony IOL The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.
Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Tecnis ZLB00 & Symfony IOL |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 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 | 38 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Binocular Uncorrected Near (40 cm) Visual Acuity.
Visual acuity measured at 40 cm without wearing any correction.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tecnis ZLB00 & Symfony IOL | Binocular Uncorrected Near (40 cm) Visual Acuity. | 0.13 logMAR | Standard Deviation 0.09 |
Secondary
Number of Participants With Visual Symptoms
Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tecnis ZLB00 & Symfony IOL | Number of Participants With Visual Symptoms | Halos : Yes | 25 Participants |
| Tecnis ZLB00 & Symfony IOL | Number of Participants With Visual Symptoms | Halos : No | 14 Participants |
| Tecnis ZLB00 & Symfony IOL | Number of Participants With Visual Symptoms | Sensitivity to light: Yes | 23 Participants |
| Tecnis ZLB00 & Symfony IOL | Number of Participants With Visual Symptoms | Sensitivity to light: No | 16 Participants |
Secondary
Patient Visual Satisfaction After Cataract Surgery: Questionnaire
Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision. Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tecnis ZLB00 & Symfony IOL | Patient Visual Satisfaction After Cataract Surgery: Questionnaire | Completely or mostly satisfied | 27 Participants |
| Tecnis ZLB00 & Symfony IOL | Patient Visual Satisfaction After Cataract Surgery: Questionnaire | Moderately satisfied | 5 Participants |
| Tecnis ZLB00 & Symfony IOL | Patient Visual Satisfaction After Cataract Surgery: Questionnaire | A little or not satisfied | 7 Participants |
Secondary
Spectacle Independence: Questionnaire
Patient's spectacle independence was assessed using the Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tecnis ZLB00 & Symfony IOL | Spectacle Independence: Questionnaire | Yes | 12 Participants |
| Tecnis ZLB00 & Symfony IOL | Spectacle Independence: Questionnaire | No | 27 Participants |