Status:
COMPLETED
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia
Lead Sponsor:
Beaver-Visitec International, Inc.
Collaborating Sponsors:
targomedGmbH
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intrao...
Detailed Description
This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intrao...
Eligibility Criteria
Inclusion
- Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
- Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
- Regular corneal astigmatism (measured by a topographer);
- Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Clear intraocular media other than cataract;
- Dilated pupil size large enough to visualize IOL axis markings postoperatively;
- Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;
- Willing and able to conform to the study requirements.
Exclusion
- Age of patient \<50 years at the day of screening;
- Regular corneal astigmatism \<0.75 D or \>4.25 D (measured by an automatic keratometer) in both eyes
- Irregular astigmatism (measured by a topographer);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- Subjects with AMD suspicious eyes as determined by OCT examination;
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- History or presence of macular edema;
- Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
- Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
- Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
- Concurrent or previous (within 30 days) participation in another drug or device investigation;
- Clinically significant dry eye as determined by the investigator´s judgement;
- Ocular surface disease (clinical symptoms or keratitis);
- Patients showing contraindications as listed in the current Instructions for use (IFU);
- Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
- In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
- zonular instability;
- need for iris manipulation;
- capsular fibrosis or other opacity; and
- inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04778501
Start Date
September 7 2021
End Date
January 31 2024
Last Update
August 20 2024
Active Locations (1)
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1
Asian Eye Institute
Makati City, Philippines, 1200