Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT03579368
Eligibility Criteria:
Inclusion Criteria:
* Patients bilaterally implanted with the Tecnis® Symfony Extended Range of Vision IOL
* Age 18 and older
* Patient targeted for emmetropic refraction both eyes (OU)
* Postoperative refractive spherical equivalent within ± 0.5 Diopters OU
* Postoperative refractive cylinder of ≤ 0.75 Diopters OU
* Clear intraocular media
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Subjects must have best corrected visual acuity (BCDVA) better than 20/30 after cataract removal and IOL implantation OU
Exclusion Criteria:
* Acute or chronic diseases or illness that would increase risk or confound study results, such as proliferative or moderate to severe background diabetic retinopathy, macular degeneration, or cystoid macular edema.
* Subjects with any anterior pathology that would be likely to increase the risk of complications from cataract and IOL surgery such as keratoconus, Fuchs dystrophy or any other previous serious corneal disease, pupil irregularity, unmanaged (severe) dry eyes, ocular infection or inflammation or uncontrolled glaucoma.
* Subjects with associated ocular conditions that could affect the stability of the IOL such as zonular dialysis or pseudoexfoliation syndrome.
* Subjects with central nervous system or motility issue such as dementia or alternating mono-fixators, e.g. amblyopia or strabismus
* Subjects with intra-operative complications such as posterior capsule rupture, or other unresolved complications affecting visual outcome
* History of any refractive or intraocular surgery (not including treatment for retinal holes)
* Clinically significant Ptosis
* Pupil abnormalities (non-reactive, tonic, abnormally shaped pupils, or pupils that do not dilate at least 3.5mm under mesopic/scotopic conditions)
* Patient participation in another clinical trial (former participation is no exclusion criterion)
* Use of systemic or ocular medication that might affect vision
* Patients whose primary visual requirement postoperatively is crisp, clear uncorrected visual acuity for near distances at less than 20 inches.
* Active ocular surface disease affecting the refractive surface properties of the cornea (i.e. Meibomian gland dysfunction, or moderate to severe dry eye etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03579368
Study Brief:
Protocol Section:
NCT03579368