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

Completed · Not applicable

Conditions studied: Cataract, Presbyopia

In brief

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.

Key facts

Study ID

NCT06567834

Run by

Empire Eye and Laser Center

People needed

60

Starts

2022-03-21

Expected to finish

2023-03-09

Last updated by the study team

2024-08-23

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcomes or increase risk to the subject, are acceptable.
• Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
• Inability to achieve keratometric stability for contact lens wearers
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Subject with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use during the course of the 6 month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
• Poorly controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
• Known ocular disease or pathology that, in the opinion of the investigator,
• may affect visual acuity
• may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
• may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Where it is running

• Empire Eye and Laser Center — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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