Clinical performance of the TRIVA T toric trifocal intraocular lens after cataract surgery

Clinical performance of the TRIVA T toric trifocal intraocular lens after cataract surgery - TRIVA T

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030581

Enrollment

Registered

2023-05-24

Start date

2022-12-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eyes operated by cararact surgery

Interventions

Group 1: Patients of age between 50 and 90 years old who will undergo bilateral cataract surgery (phacoemulsification) and will be implanted with the lens under study (TRIVA T-aAY)

Eligibility

Sex/Gender

All

Age

50 Years to 90 Years

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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). All data will be included in the center's patient record as part of standard clinical practice and, additionally, included in a database with a numerical code assigned to each patient.	—

Measure

Time frame

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). All data will be included in the center's patient record as part of standard clinical practice and, additionally, included in a database with a numerical code assigned to each patient.

—

Secondary

Measure	Time frame
- Assessment of uncorrected and corrected visual acuity at distance (6 m), intermediate (60 cm) and near (40 cm). - Assessment of lens rotational stability. - Assessment of patient satisfaction and quality of life.	—

Countries

Spain

Contacts

Public ContactPedro Tañá Rivero

Doctor, coordinating investigator and Promoter's representative of OFTALVIST (Oftalmología Vistahermosa, SL)

maria.cobo@oftalvist.es+34963513304

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026