Clinical Performance of a Phakic Intraocular Lens (IOL)

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: EDOF ICL

• Registration Number: NCT03499821
• Lead Sponsor: Staar Surgical Company

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.

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-17
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Disposition First Submitted: 2020-07-16
• Results First Submitted: 2022-05-20
• Results First Submitted QC: 2022-08-25
• Disposition First Submitted QC: 2022-08-25
• Results First Posted: 2022-09-21
• Disposition First Posted: 2022-09-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	EDOF ICL	EDOF ICL implanted into both eyes of eligible subjects.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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
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
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 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 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 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 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
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 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

Trial Locations

Locations (6)

Mediopolis; 🇧🇪 Antwerp, Belgium

IMO Instituto de Microcirugía Ocular; 🇪🇸 Barcelona, Spain

Qvision-Hospital Vithas Virgen del Mar; 🇪🇸 Almería, Spain

Innova Ocular Begitek; 🇪🇸 San Sebastián, Spain

Clínica Oftalmológica Gasteiz; 🇪🇸 Vitoria-Gasteiz, Spain

Instituto Oftalmológico Fernández-Vega; 🇪🇸 Oviedo, Asturias, Spain