N/A
Completed N=475
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Cataract · Corneal Astigmatism
Source: ClinicalTrials.gov NCT03791619 ↗
Enrolled (actual)
475
Serious AEs
14.1%
Results posted
Aug 2023
Primary outcomePrimary: Rate of Bothersome Visual Symptoms — 19; 19 Participants
Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Bothersome Visual Symptoms |
19; 19 | — |
| PRIMARY Rate of Difficulty With an Activity Due to the Visual Symptoms |
28; 26 | — |
Eligibility Criteria
Inclusion Criteria
- be at least 22 years old
- have cataracts in both eyes
- have a certain degree of astigmatism in at least one eye
- sign the written informed consent
- be willing and able to comply with examination procedures
- understand, read and write English to complete informed consent and questionnaires
- be available for study follow-up visits
Both eyes must qualify to be eligible to participate in the study
Exclusion Criteria
- Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- Have a certain disease/illness such as poorly-controlled diabetes
- Have certain ocular conditions such as uncontrolled glaucoma
- Taking medication that may affect subject vision
- Have irregular corneal astigmatism
- Pregnant, plan to become pregnant during the study, or is breastfeeding
Data sourced from ClinicalTrials.gov (NCT03791619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.