Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs (NCT06567834) | Clinical Trial Compass
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 range22 Years
SexALL
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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…