Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
Launched by SIFI SPA · Jul 15, 2016
Trial Information
Current as of May 25, 2025
Completed
Keywords
ClinConnect Summary
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Any gender and age above 18 years.
- • Refractive lens exchange (RLE) or cataract surgery.
- • Healthy corneas, not treated surgically.
- • Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
- • Patients request to receive the IOL MINI WELL READY implant
- Exclusion Criteria:
- • Previous corneal surgery (i.e. pterygium, refractive surgery).
- • Eye diseases determining a probable postoperative visual acuity \< 20/40.
- • Pseudoexfoliation.
- • Abnormal pupil size and position.
- • Use of contact lens 30 days before the preoperative visit.
- • Corneal warpage.
- • Predicted postoperative corneal astigmatism higher than 1 D.
About Sifi Spa
SIFI S.p.A. is a leading Italian pharmaceutical company specializing in the research, development, and commercialization of innovative products for ocular health. With a strong commitment to advancing eye care, SIFI focuses on delivering high-quality ophthalmic solutions that address unmet medical needs. The company is dedicated to clinical excellence and collaborates with healthcare professionals and institutions to ensure the efficacy and safety of its products. SIFI's extensive portfolio includes a range of therapies for conditions such as glaucoma, dry eye, and post-surgical care, reflecting its mission to enhance the quality of life for patients around the world.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heidelberg, , Germany
Patients applied
Trial Officials
GERD U. AUFFARTH, Prof. Dr.
Principal Investigator
RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials