Phase
Condition
Eye Disorders/infections
Vision Loss
Eye Disease
Treatment
Symfony IOL
Vivity IOL
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is undergoing bilateral lens extraction with implantation of an EDOF IOLwith a target refraction of plano OU.
Gender: Males and Females.
Age: 50 years and older.
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 in both eyes, with 1 to 30 daysbetween surgeries.
Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better inboth eyes.
Exclusion
Exclusion Criteria:
Severe preoperative ocular pathology
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.
Corneal irregularities potentially affecting visual acuity (i.e., keratoconus,corneal opacities.
History of chronic intraocular inflammation.
History of retinal detachment.
Pseudoexfoliation syndrome or any other condition that has the potential to weakenthe zonules.
Previous intraocular surgery.
Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
Subject who declined any type of presbyopia correcting IOL due to concerns withvisual disturbances (i.e., halos)
Previous keratoplasty
Severe dry eye
Pupil abnormalities
Subject who may reasonably be expected to require a secondary surgical interventionat any time during the study (other than YAG capsulotomy, i.e., LASIK)
Any clinically significant, serious, or severe medical or psychiatric condition thatmay increase the risk associated with study participation or may interfere with theinterpretation of study results.
Participation in (or current participation) any ophthalmic investigational drug orophthalmic device trial within the previous 30 days prior to the start date of thistrial.
Study Design
Connect with a study center
Center for Sight
Sarasota, Florida 34239
United StatesSite Not Available
Carolina Eyecare Physicians, LLC
Mount Pleasant, South Carolina 29464
United StatesSite Not Available

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