Performance evaluation of a device for preoperative visualisation of the postoperative visual impression in near, intermediate and far distance

Performance evaluation of a device for preoperative visualisation of the postoperative visual impression in near, intermediate and far distance - IOL visualisation study NIF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035609

Enrollment

Registered

2025-01-08

Start date

2024-03-05

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

H52.4

Interventions

Group 1: There is only one observation group. Preoperative tests: Patients are tested during the preliminary examinations for intraocular lens implantation, which is performed independently of this cl

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Clear lens patients (not yet clinically relevant onset of cataract) with short-sightedness, long-sightedness, presbyopia and desire to be spectacle-free; - Visual acuity with visual aid cc = 80 %; - Astigmatism = 3.0 D; - Willingness to participate in the study and willingness to participate in all follow-up visits; - Signed declaration of consent

Exclusion criteria

Exclusion criteria: - Astigmatism > 3.0 D; - Irregular astigmatism; - Patients with vision-impairing eye diseases (e.g. glaucoma, AMD, corneal opacities or other retinal or optic disorders); - Previous intraocular or corneal surgery; - Traumatic cataract; - Expected complicated surgery; - Postoperative refractive error > 1 D or 0.75 D - Pupillary abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions); - Additionally, subjects will be excluded if certain conditions are present at the time of surgery, including: o zonular instability; o Capsular fibrosis; o Need for iris manipulation; o Inability to fix the IOL in the desired position; o Complications during surgery

Design outcomes

Primary

Measure	Time frame
Agreement of preoperative visual acuity and contrast sensitivity tests performed with the TRAVIS Device with postoperative tests performed with the TRAVIS Device and compensating lens (required for near, intermediate and far distance).	—

Secondary

Measure	Time frame
Agreement of visual acuity and contrast sensitivity tests carried out postoperatively with the TRAVIS device with tests also carried out postoperatively with refractive spectacles (each required for near, intermediate and far distance).	—

Countries

Germany

Outcome results

None listed

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