Non-Inferiority Study Comparing MINI WELL READY® and FineVision® in Patients With Cataract Surgery
Study Details
Study Description
Brief Summary
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MINI WELL READY ® BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY |
Device: MINI WELL READY ®
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
|
| Other: FineVision ® FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY |
Device: FINE VISION®
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
|
Outcome Measures
Primary Outcome Measures
- Defocus curve - binocular [6 months]
Defocus curve assessment
Other Outcome Measures
- Refraction [6 months]
Ocular refraction evaluation
- Visual Acuity Evaluation [6 months]
Uncorrected Distance Visual Acuity (UDVA)
- Visual Acuity Evaluation [6 months]
Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)
- Visual Acuity Evaluation [6 months]
Distance Corrected Intermediate Visual Acuity (DCIVA)
- Visual Acuity Evaluation [6 months]
Uncorrected Near Visual Acuity (UNVA)
- Visual Acuity Evaluation [6 months]
Distance Corrected Near Visual Acuity (DCNVA)
- Reading speed [6 months]
Reading speed performance
- Halometry [6 months]
Halos evaluation
- Contrast sensitivity [6 months]
Contrast sensitivity evaluation
- Subject satisfaction questionnaire - VF-11R [6 months]
Subject satisfaction questionnaire - VF-11R "revised version": Annex A: Subject's glasses independence and light dependence Annex B: Quality of Vision (QoV) questionnaire
- Operative Complications / Postoperative Complications / Adverse Event Assessment [6 months]
Assessment of Operative Complications, Postoperative Complications, Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Bilateral cataract surgery required, no other ocular comorbidities
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Healthy corneas, not treated surgically
-
Available for second-eye surgery within 1 week of the initial operation
-
Spherical refraction between -8.00D and +6.00D
-
Willing to adhere to the study visit schedule
-
Normal anterior and posterior segments
-
Clear intraocular media - other than cataract
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To benefit from a social security system before being enrolled
-
Written informed consent consistent with local regulation research in human subjects
Exclusion Criteria:
-
Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)
-
Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
-
Expected to require retinal laser treatment
-
A history of retinal detachment or predisposition for such disorder
-
Psudoexfoliation
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Abnormal pupil size and position
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Pupil size > 7 mm under mesopic condition
-
Use of contact lenses 30 days before the preoperative visit
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Corneal warpage (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
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Corneal astigmatism greater than 0.75D
-
Zonular laxicity
-
Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag
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Microphthalmus
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Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch's endothelial dystrophy)
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Suspected microbial infection
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Irregularities and capsulorexis decentralization
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Surgical difficulties that may increase the risk of complications such as persistent bleeding, significant iris damage, an uncontrollable intraocular hypertonia, or damage due to significant vitreous loss
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Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat diseases of the posterior segment
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Patients in whom neither the posterior capsule nor the zonula can provide adequate support to the lens
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Subjects with any systemic disease that could increase operative risk or confound the outcome
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Pregnant or lactating or planning a pregnancy at the time of enrolment
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Vulnerable subjects (children <18 years, people in guardianship or trusteeship or inability to give an informed consent)
-
Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ophtalmologie Hôpital Morvan | Brest | France | ||
| 2 | Clinique Juge | Marseille | France | 13008 |
Sponsors and Collaborators
- SIFI SpA
- Opera CRO, a TIGERMED Group Company
Investigators
- Study Director: Gianluca Stivale, SIFI SpA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PSM29