CompletedNot Applicable

Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs

United States60 participantsStarted 2022-03-21

Plain-language summary

The goal of this clinical study is to compare the Tecnis Symfony Optiblue intraocular lens implant to the Tecnis Symfony intraocular lens implant in patients over 22 years old with cataracts in both eyes. The main questions it aims to answer are: Which lens has less nighttime side effects? Which lens has higher patient satisfaction? Participants will undergo a minimum of 7 study visits where they will complete a variety of vision tests and vision questionnaires.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All criteria apply to each study eye * Minimum 22 years of age * Bilateral cataracts for which posterior chamber IOL implantation has been planned * Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source * Potential for postoperative BCDVA of 20/30 Snellen or better * Corneal astigmatism: * Normal corneal topography * Preoperative corneal astigmatism range from 0 D - 2.0 D * Clear intraocular media other than cataract in each eye * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures * Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries * Ability to understand and respond to a questionnaire in English Exclusion Criteria: * All criteria apply to each study eye: * Requiring an intraocular lens power outside the available range of power * Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) * Irregular corneal astigmatism * Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * Prior corneal refractive surgery (LASIK, LASEK, radial keratotomy (RK), photorefractive keratectomy (PRK), etc.) or intraocular surgery. Note: Prophylactic peripheral iridoto…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient reported nighttime dysphotopsia symptoms

Timeframe: Pre-op visit, 1 month post-op visit, 6 month post-op visit

Trial details

NCT IDNCT06567834

SponsorEmpire Eye and Laser Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-09

View on ClinicalTrials.gov More Cataract trials