PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104)

Not Applicable

Completed

• Conditions: Cataract; Lens Opacities; Astigmatism

• Registration Number: NCT04987216
• Lead Sponsor: Beaver-Visitec International, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-7-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Inclusion Criteria:<br><br> - Male or female adults ages 50 years or older on the day of screening who have<br> clinically documented cataracts in both eyes;<br><br> - Calculated IOL power (sphere and cylinder) is within the range of the<br> investigational IOLs;<br><br> - Regular corneal astigmatism (measured by a topographer);<br><br> - Corneal astigmatism =0.75 D and = 4.25 D (measured by an automatic keratometer) in<br> one or both eyes;<br><br> - Capability to understand and sign an IRB approved informed consent form and privacy<br> authorization;<br><br> - Clear intraocular media other than cataract;<br><br> - Dilated pupil size large enough to visualize IOL axis markings postoperatively;<br><br> - Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL<br> implantation;<br><br> - Willing and able to conform to the study requirements.<br><br>Exclusion Criteria:<br><br> - Age of patient <50 years at the day of screening;<br><br> - Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic<br> keratometer) in both eyes<br><br> - Irregular astigmatism (measured by a topographer);<br><br> - Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or<br> other retinal or optic disorders);<br><br> - Subjects with AMD suspicious eyes as determined by OCT examination;<br><br> - Previous intraocular or corneal surgery;<br><br> - Traumatic cataract;<br><br> - History or presence of macular edema;<br><br> - Instability of keratometry or biometry measurements; Acceptable maximum standard<br> deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;<br><br> - Clinically significant, uncontrolled glaucoma with expected negative impact on<br> Contrast Sensitivity and/or visual acuity outcomes;<br><br> - Pregnant, lactating or, if able to bear children, unwilling to use medically<br> acceptable birth control over the course of the study;<br><br> - Concurrent or previous (within 30 days) participation in another drug or device<br> investigation;<br><br> - Clinically significant dry eye as determined by the investigator's judgement;<br><br> - Ocular surface disease (clinical symptoms or keratitis);<br><br> - Patients showing contraindications as listed in the current Instructions for use<br> (IFU);<br><br> - Unsuitable for study participation for any other reason, as determined by<br> Investigator's clinical judgment (reason to be documented on eCRF).<br><br>In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued<br>when certain conditions are present at the time of surgery, including:<br><br> - zonular instability;<br><br> - need for iris manipulation;<br><br> - capsular fibrosis or other opacity; and<br><br> - inability to fixate IOL in desired position. In such cases, the subject shall be<br> followed until the condition has stabilized.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation

Secondary Outcome Measures

Name	Time	Method
Best Corrected Distance Visual Acuity compared to historical Data;Change in cylindrical Power of the Eye