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Search / Trial NCT02838004

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

Refractive Lens Exchange (Rle) Or Cataract Surgery

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.

Locations

Heidelberg, , Germany

Patients applied

0 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

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