Status:
COMPLETED
Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes
Lead Sponsor:
Carolina Eyecare Physicians, LLC
Collaborating Sponsors:
Science in Vision
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Cataract Bilateral
Presbyopia
Eligibility:
All Genders
40+ years
Phase:
NA
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 activit...
Eligibility Criteria
Inclusion
- Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
- Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
- Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion
- Contraindication for a presbyopia correcting IOL.
- Subjects with severe astigmatism in the non-dominant eye
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous intraocular surgery.
- Previous refractive surgery.
- Previous keratoplasty
- Severe dry eye
- Pupil abnormalities
- 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)
- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- 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.
- 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.
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03771274
Start Date
December 7 2018
End Date
October 31 2019
Last Update
August 10 2020
Active Locations (1)
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1
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, United States, 29464