Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant
Study Details
Study Description
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 Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo & Glare Simulator.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MINI WELL Ready (SIFI SpA, Italy) Extended depth of focus intraocular lens implantation |
Device: MINI WELL Ready (SIFI SpA, Italy)
Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients.
|
Outcome Measures
Primary Outcome Measures
- Subjective Refraction [26 months]
- Binocular Defocus Curve [26 months]
Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments)
- UDVA [26 months]
Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m
- CDVA [26 months]
Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m
- UIVA at 100 cm [26 months]
Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast)
- DCIVA at 100 cm [26 months]
Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast)
- UIVA at 60 cm [26 months]
Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)
- DCIVA at 60 cm [26 months]
Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)
- UNVA [26 months]
Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast)
- DCNVA [26 months]
Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast)
- Contrast Sensitivity [26 months]
Binocular Contrast Sensitivity with correction for distance
- Reading Performance [26 months]
Binocular Reading Performance with and without correction for distance
- VR-11R [26 months]
Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties)
Secondary Outcome Measures
- Postoperative Complications Rate of postoperative complication [26 months]
- Subjective Posterior Capsule Opacification [20-26 months]
Subjective assessment through slit lamp
- Posterior Capsulotomy [26 months]
- Adverse Events including SSIs [26 months]
- Device Deficiencies [26 months]
Descriptive assessment
- Photic Phenomena Assessment [26 months]
Using the Halo and Glare Simulator software
Eligibility Criteria
Criteria
Inclusion Criteria:
• Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:
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Any gender and age above 18 years.
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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.
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Symmetrical preoperative keratometric astigmatism < 1.00 D.
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Healthy corneas, not surgically treated
Exclusion Criteria:
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Previous corneal surgery (i.e. pterygium, refractive surgery).
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Eye diseases with visual acuity < 20/32.
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Pseudoexfoliation.
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Abnormal pupil size and position.
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Use of contact lens 30 days before the preoperative visit.
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Corneal warpage.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- SIFI SpA
- Opera CRO, a TIGERMED Group Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PSM8 Sub-study