Clinical performance of the TRIVA T toric trifocal intraocular lens after cataract surgery
- Conditions
- Eyes operated by cararact surgery
- Registration Number
- DRKS00030581
- Lead Sponsor
- Doctor, coordinating investigator and Promoter's representative of OFTALVIST (Oftalmología Vistahermosa, SL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
Adult male or female patient (age 50-90 years) undergoing bilateral cataract surgery (phacoemulsification).
- Willingness and sufficient cognitive awareness to comply with examination procedures.
- Signed informed consent.
- Preoperative corneal astigmatism 0.75 Diopters (D) in at least one of the two eyes.
- Clear intraocular media other than cataract.
- Candidate for TRIVA T-aAY intraocular lens (HumanOptics, Erlangen, Germany, CE certified) following medical criteria in at least one of the two eyes.
- Patients unable/unwilling to give informed consent.
- Patients unable to understand the requirements of the study.
- Irregular cornea (e.g. keratoconus).
- Previous corneal refractive surgery.
- Ocular abnormalities or pathologies that could reduce visual function or postoperative stability of the intraocular lens (e.g. severe amblyopia, macular degeneration).
- Uncontrolled glaucoma
- Retinal detachment, macular degeneration or retinopathy.
- Non-reactive pupils
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the clinical performance, visual and refractive outcomes of the TRIVA T-aAY lens after cataract surgery. It will be evaluated with the following outcomes: assessment of manifest refraction and evaluation of the defocus curve. All information resulting from the examinations will first be documented in the patient's record and then registered on the evaluation forms (CRD). <br>All data will be included in the center's patient record as part of standard clinical practice and, additionally, included in a database <br>with a numerical code assigned to each patient.
- Secondary Outcome Measures
Name Time Method - Assessment of uncorrected and corrected visual acuity at distance (6 m), intermediate (60 cm) and near (40 cm).<br>- Assessment of lens rotational stability.<br>- Assessment of patient satisfaction and quality of life.