Status:
COMPLETED
Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision
Lead Sponsor:
Clinica Baviera
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Brief Summary
The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bila...
Eligibility Criteria
Inclusion
- Signed informed consent
- Availability to complete follow-up examinations up to 6 months after surgery
- Cataract for which removal by phacoemulsification and subsequent IOL implantation was planned
- CDVA was expected to be better than 20/30 (+0.18 logMAR) after IOL implantation
- IOL power calculated in the range of +10.0 to +30.0 D
- Corneal astigmatism \< 1.50 D
- Candidate for refractive surgery in monovision configuration
Exclusion
- Women who were pregnant, nursing or planning to become pregnant during the study
- Difficulty for cooperation
- Inability to provide informed consent
- Concurrent participation in another investigational drug or device
- History of ocular trauma
- Previous intraocular or corneal surgery
- Presence of ocular pathologies
- Subjects with diagnosed degenerative visual disorders that were predicted to cause future acuity losses to a level of 20/30 or worse
- Subjects who may be expected to require retinal laser treatment
- Other eye condition that in the opinion of the investigator prevents the subject's participation in the study.
- Any other condition that may be contraindicated according to the IOL Instructions for Use.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06528678
Start Date
April 30 2021
End Date
October 24 2023
Last Update
July 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinica Baviera
Valencia, Spain, 46004