Status:
COMPLETED
PMCF Retrospective Study Outcomes of a Premium Monofocal IOL
Lead Sponsor:
Beaver-Visitec International, Inc.
Collaborating Sponsors:
targomedGmbH
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopu...
Detailed Description
The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implan...
Eligibility Criteria
Inclusion
- • Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.3. intraocular lens minimum 120 days before the study visit;
- Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Clear intraocular media;
- Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
- Willing and able to conform to the study requirements.
Exclusion
- • Age of patient \<45 years at the day of surgery;
- Time between first and second eye treatment: \>45 days (this accounts for bilateral implantations only);
- Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
- Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
- Subjects in whom in-the-bag implantation was not possible;
- Subjects in whom surgical complications occurred (e.g. posterior rupture).
- Subjects showing glaucoma;
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2022
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04874376
Start Date
May 24 2021
End Date
January 12 2022
Last Update
July 20 2022
Active Locations (6)
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1
Oftalvist, Alicante
Alicante, Spain
2
Vithas, Alicante
Alicante, Spain
3
Clinica Baviera
Madrid, Spain
4
HM Monteprincipe
Madrid, Spain