Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.
This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic [EDOF ICL] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add.
Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery.
The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance.
The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Experimental | EDOF ICL implanted into both eyes of eligible subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDOF ICL | Device | The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation | Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation | Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 1 month after implantation | 1 month |
| Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation |
Not provided
Inclusion Criteria:
Must be able to read, understand and provide written informed consent,
Willing and able to comply with all treatment and follow-up study related procedures,
40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
Best Corrected Distance Visual Acuity 20/20 or better in both eyes,
Requires +1.00 D to +2.50 D reading add,
Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,
ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D,
Anterior chamber angle ≥ Grade III,
Phakic in both eyes,
Current contact lens wearers need to demonstrate a stable refraction, (± 0.5 D), expressed as MRSE, on two consecutive examination dates with refractive stability determined by the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne Egamino, PhD | Staar Surgical Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mediopolis | Antwerp | B-2610 | Belgium | |||
| Instituto Oftalmológico Fernández-Vega |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32982164 | Result | Packer M, Alfonso JF, Aramberri J, Elies D, Fernandez J, Mertens E. Performance and Safety of the Extended Depth of Focus Implantable Collamer(R) Lens (EDOF ICL) in Phakic Subjects with Presbyopia. Clin Ophthalmol. 2020 Sep 18;14:2717-2730. doi: 10.2147/OPTH.S271858. eCollection 2020. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 41 subjects were screened in the study. Six did not meet eligibility and 35 subjects were treated at 6 clinical sites in Europe (5 sites in Spain and 1 site in Belgium). The first enrolled subject underwent bilateral surgery in May 2018, the last subject completed the last study visit in July 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | Study Population | Extended Depth of Field (EDOF) Implantable Collamer Lens (ICL) implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Population | EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation | Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation | Posted | Count of Units | Eyes | 6 months | Eyes | Eyes |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Population | EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
The study included subjects with residual accommodation. In order to further elucidate the performance of the EDOF ICL vis a vis severity of presbyopia at baseline, the performance of those eyes and subjects which not only required a reading add but also exhibited distance corrected near visual acuity of 20/40 or worse at baseline was examined. Refer to publication in reference module for more details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Egamino | STAAR Surgical | 626-303-7902 | jegamino@staar.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2018 | May 20, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Device: Open label, all subjects receive same treatment
Not provided
Not provided
Not provided
Not provided
|
|
Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 3 months after implantation |
| 3 months |
| Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 1 month post implantation | Baseline and 1 month |
| Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 3 months post implantation | Baseline and 3 months |
| Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 6 months post implantation | Baseline and 6 months |
| Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation | Baseline and 1 month |
| Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation | Baseline and 3 months |
| Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 6 months post implantation | Baseline and 6 months |
| Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 1 month post implantation | Baseline and 1 month |
| Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 3 months post implantation | Baseline and 3 months |
| Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | Change from baseline in Monocular Distance corrected intermediate visual acuity (DCIVA) at 80 cm 6 months post implantation | Baseline and 6 months |
| Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 1 month post implantation | Baseline and 1 month |
| Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 3 months post implantation | Baseline and 3 months |
| Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 6 months post implantation | Baseline and 6 months |
| Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation | Baseline and 1 month |
| Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation | Baseline and 3 months |
| Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Change from baseline in Binocular Uncorrected Near Visual Acuity (UCNVA) at 40 cm 6 months post implantation | Baseline and 6 months |
| Oviedo |
| Principality of Asturias |
| 33012 |
| Spain |
| Qvision-Hospital Vithas Virgen del Mar | Almería | 04120 | Spain |
| IMO Instituto de Microcirugía Ocular | Barcelona | 08035 | Spain |
| Innova Ocular Begitek | San Sebastián | 20012 | Spain |
| Clínica Oftalmológica Gasteiz | Vitoria-Gasteiz | 01005 | Spain |
| eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Monocular UNVA better than 20/40 at Preoperative Visit | Monocular uncorrected near visual acuity (UNVA) at Preoperative Visit | Number | Eyes | eyes |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Eyes |
|
|
| Secondary | Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation | Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 1 month after implantation | Posted | Count of Units | Eyes | 1 month | Eyes | Eyes |
|
|
|
| Secondary | Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation | Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 3 months after implantation | Posted | Count of Units | Eyes | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 1 month post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 1 month | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 3 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 3 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 6 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 6 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 1 month | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 3 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 6 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 6 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 1 month post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 1 month | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 3 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 3 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | Change from baseline in Monocular Distance corrected intermediate visual acuity (DCIVA) at 80 cm 6 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 6 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 1 month post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 1 month | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 3 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 3 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 6 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 6 months | Eyes | Eyes |
|
|
|
| Secondary | Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 1 month |
|
|
|
| Secondary | Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 3 months |
|
|
|
| Secondary | Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Change from baseline in Binocular Uncorrected Near Visual Acuity (UCNVA) at 40 cm 6 months post implantation | Posted | Mean | Standard Deviation | Lines of Vision Gained | Baseline and 6 months |
|
|
|
| 0 |
| 35 |
| 9 |
| 35 |
| 13 |
| 35 |
| Vascular Migraine with Aura | Nervous system disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Corneal Oedema | Eye disorders | Systematic Assessment |
|
| Eye Pruritus | Eye disorders | Systematic Assessment |
|
| Eye Inflammation | Eye disorders | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | Systematic Assessment |
|
| Hordeolum | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Intraocular Pressure Increased | Investigations | Systematic Assessment |
|
| Conjunctival Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to the Sponsor or designee for comment.