Status:
COMPLETED
Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant
Lead Sponsor:
SIFI SpA
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Brief Summary
The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Inte...
Detailed Description
The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)
Eligibility Criteria
Inclusion
- • Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:
- Any gender and age above 18 years.
- Cataract or Refractive Lens Exchange (RLE) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position.
- Symmetrical preoperative keratometric astigmatism \< 1.00 D.
- Healthy corneas, not surgically treated
Exclusion
- Previous corneal surgery (i.e. pterygium, refractive surgery).
- Eye diseases with visual acuity \< 20/32.
- Pseudoexfoliation.
- Abnormal pupil size and position.
- Use of contact lens 30 days before the preoperative visit.
- Corneal warpage.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 19 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04801992
Start Date
October 26 2020
End Date
November 19 2020
Last Update
March 22 2021
Active Locations (1)
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1
U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"
Bari, Italy, 70121