Performance evaluation of a device for preoperative visualisation of the postoperative visual impression

Performance evaluation of a device for preoperative visualisation of the postoperative visual impression - IOL-visualisation-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034568

Enrollment

Registered

2024-07-01

Start date

2023-04-25

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: The patients are tested during the preliminary examinations for intraocular lens implantation, which is carried out independently of t

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

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; * Pupillary abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions); * In addition, subjects will be dropped if certain conditions are present at the time of surgery, including: - zonular instability; - Capsular fibrosis; - Need for iris manipulation; - Inability to place the IOL in the desired position

Design outcomes

Primary

Measure	Time frame
Agreement of visual acuity and contrast sensitivity tests carried out preoperatively with the TRAVIS Device with tests carried out postoperatively with the TRAVIS Device and compensating lens (each required for distance and near 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 distance and near distance).	—

Countries

Germany

Contacts

Public ContactWolfgang Brezna

ACMIT Gmbh

wolfgang.brezna@acmit.at+43 262222859

Outcome results

None listed

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