Status:
COMPLETED
PMCF Study on Comparison of EDOF Lenses (Switzerland)
Lead Sponsor:
Beaver-Visitec International, Inc.
Collaborating Sponsors:
targomedGmbH
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1...
Detailed Description
This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implanta...
Eligibility Criteria
Inclusion
- Cataractous eyes with no comorbidity;
- Calculated IOL power is within the range of the study IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
- Regular total corneal astigmatism ≤1.0 D (measured by topography method)
- Clear intraocular media other than cataract;
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
- Signed informed consent.
Exclusion
- Age of patient \< 50 years;
- Regular total corneal astigmatism \>1.0 dioptres (measured by topography method)
- Irregular astigmatism;
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker;
- Previous intraocular or corneal surgery or intravitreal injection;
- Traumatic cataract;
- History or presence of macular edema;
- Glaucoma with visual field defects;
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
- Amblyopia with monocular preoperative CDVA of \>0.1 logMAR;
- Cornea guttata;
- Keratoconus;
- Chronic uveitis;
- Expected complicated surgery;
- Significant dry eye;
- Contra-indications as listed in the current Instructions for use (IFU);
- Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery;
- Concurrent or previous (within 60 days) participation in another drug or device investigation.
- 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 or defect;
- 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 :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05235139
Start Date
March 9 2022
End Date
August 22 2023
Last Update
May 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eye center Vista Alpina
Visp, Switzerland, 3930