Presbyopia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEDOF 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.
Sponsors
Staar Surgical Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Device: Open label, all subjects receive same treatment
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Must be able to read, understand and provide written informed consent, 2. Willing and able to comply with all treatment and follow-up study related procedures, 3. 40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D, 4. 35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D, 5. Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder, 6. \< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions, 7. Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE), 8. Best Corrected Distance Visual Acuity 20/20 or better in both eyes, 9. Requires +1.00 D to +2.50 D reading add, 10. Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D, 11. ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D, 12. Anterior chamber angle ≥ Grade III, 13. Phakic in both eyes, 14. 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: 1. contact lenses were not worn for at least 2 weeks (rigid and toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction, 2. two refractions were performed at least 7 days apart.
Exclusion criteria
1. Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation, 2. Previous intraocular or corneal surgery in either eye, including refractive surgery, 3. Progressive sight threatening disease or other previous or current ocular conditions, other than myopia in either eye, 4. Low/abnormal corneal endothelial cell density, 5. Amblyopia, 6. Presence of active or history of chronic inflammation in either eye, 7. Clinically significant irregular astigmatism in either eye, 8. Serious, acute, chronic or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion, 9. Use of topical steroids at time of implantation, 10. Systemic or topical medication, other than prescribed study medications that may confound the outcome or increase the risk to the subject, 11. Allergy to anesthetics or other postoperative medications required in this study, 12. Subject who is pregnant, plans to become pregnant, or is lactating during the course of the study, or has another condition associated with the fluctuation of hormones that could lead to refractive changes, 13. Subjects who present any emotional, physiologic, or anatomical condition which may preclude study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation | 6 months | Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Baseline and 3 months | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 3 months post implantation |
| Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Baseline and 6 months | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 6 months post implantation |
| Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation | 1 month | Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 1 month after implantation |
| Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation | 3 months | Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 3 months after implantation |
| Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | Baseline and 1 month | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 1 month post implantation |
| Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | Baseline and 3 months | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 3 months post implantation |
| Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | Baseline and 6 months | Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 6 months post implantation |
| Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Baseline and 1 month | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation |
| Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Baseline and 3 months | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation |
| Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Baseline and 6 months | Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 6 months post implantation |
| Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | Baseline and 1 month | Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 1 month post implantation |
| Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | Baseline and 3 months | Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 3 months post implantation |
| Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | Baseline and 6 months | Change from baseline in Monocular Distance corrected intermediate visual acuity (DCIVA) at 80 cm 6 months post implantation |
| Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Baseline and 1 month | Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation |
| Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | Baseline and 3 months | Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation |
| Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation | Baseline and 1 month | Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 1 month post implantation |
| Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | Baseline and 6 months | Change from baseline in Binocular Uncorrected Near Visual Acuity (UCNVA) at 40 cm 6 months post implantation |
Countries
Belgium, Spain
Contacts
STUDY_DIRECTORJoanne Egamino, PhD
Staar Surgical Company
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 70 |
| Total | 105 |
Baseline characteristics
| Characteristic | Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Monocular UNVA better than 20/40 at Preoperative Visit | 15 Eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment Belgium | 10 Participants |
| Region of Enrollment Spain | 25 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 13 / 35 |
| serious Total, serious adverse events | 9 / 35 |
Outcome results
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Study Population | Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation | 66 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
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | 5.95 Lines of Vision Gained | Standard Deviation 3.99 |
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
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | 5.99 Lines of Vision Gained | Standard Deviation 4.01 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | 6.12 Lines of Vision Gained | Standard Deviation 3.96 |
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
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | .24 Lines of Vision Gained | Standard Deviation 2 |
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
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | .31 Lines of Vision Gained | Standard Deviation 2.02 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | .44 Lines of Vision Gained | Standard Deviation 2.09 |
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
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation | 1 Lines of Vision Gained | Standard Deviation 1.6 |
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
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation | .92 Lines of Vision Gained | Standard Deviation 1.74 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation | 1.11 Lines of Vision Gained | Standard Deviation 1.62 |
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
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation | 7.63 Lines of Vision Gained | Standard Deviation 3.42 |
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
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation | 7.69 Lines of Vision Gained | Standard Deviation 3.48 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation | 7.79 Lines of Vision Gained | Standard Deviation 3.53 |
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
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation | 5.96 Lines of Vision Gained | Standard Deviation 3.9 |
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
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation | 5.93 Lines of Vision Gained | Standard Deviation 4.05 |
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
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation | 6.22 Lines of Vision Gained | Standard Deviation 3.95 |
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
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Study Population | Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation | 66 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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Study Population | Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation | 66 Eyes |