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

• Conditions: H52.4; Presbyopia

• Registration Number: DRKS00034568
• Lead Sponsor: ACMIT Gmbh

Brief Summary

For the cases without the use of mydriatics, all hypotheses for visual acuity and contrast sensitivity were confirmed. Thus, the TRAVIS device (without the use of mydriatics) enables the prediction of postoperative visual acuity of better than 0.1 logMAR and for postoperative contrast sensitivity of better than 0.25 logCSWeber.

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-24
• Study Start: 2024-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

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

* 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).