A Clinical Evaluation of a Phakic Intraocular Lens

The objective of this study is to evaluate the clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens with Aspheric (EDOF) Optic as refractive elements to correct or reduce myopia or hyperopia with presbyopia with or without astigmatism.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: Implantable Collamer Lens (ICL)

Detailed Description

This prospective, open-labeled, evaluation of clinical performance of the investigational EDOF and Toric EDOF (TEDOF) ICL will be conducted at a single site in the Philippines.

Up to 45-50 subjects (90 eyes) who meet all eligibility criteria will be assigned to one of the following treatment arms, as determined by their preoperative refraction and the Investigator's medical judgement:

• EDOF Toric ICL in both eyes,
• EDOF Toric ICL in one eye and EDOF spherical ICL in fellow eye,
• EDOF spherical ICL in both eyes (up to 20 subjects/40 eyes).

Postoperatively, subjects will undergo ophthalmic examination at regular intervals per the study visit schedule up to 6 months after surgery.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Makati City, Philippines
    • Asian Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Require a spherical lens power from -18.00 Diopters to +3.00 Diopters in both eyes or (in case of EDOF Toric) additional cylindrical lens power between +1.0 to +3.0 Diopters of Cylinder.
• Stable refractive history (+/-0.50 Diopters) as determined by manifest spherical equivalent.
• Requires +1.00 Diopters to +2.50 Diopters reading add in both eyes.
• Minimum distance corrected near visual acuity of 20/40 or worse in both eyes.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• History of previous ocular surgery.
• Progressive sight threatening disease.
• Low/abnormal endothelial cell density.
• Monocular.
• Serious acute non-ophthalmic disease.
• Pregnant or nursing women, or those who plan to become pregnant over the course of the study.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EDOF ICL; Eyes treated EVO+ Visian and EVO+ Toric Implantable collamer lens with aspheric optic determined by their preoperative refraction	Device: Implantable Collamer Lens (ICL); EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity	Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity	1 month, 3 months and 6 months postoperatively
Change in refractive cylinder	Change from baseline in absolute magnitude of subjective refractive cylinder	1 month, 3 months and 6 months postoperatively
Lens axis misalignment	Proportion of lenses with axis misalignment compared to operative day	1 month, 3 months and 6 months postoperatively
Rotational stability	Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery	1 day, 1, week, 1 month, 3 months and 6 months postoperatively
Compromise in visual acuity	Clinically significant compromise in visual acuity based on subject questionnaires	6 months postoperatively

Collaborators and Investigators

• Sponsor: Staar Surgical Company

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism; Hyperopia; Presbyopia
• Other Study ID Numbers: CP18-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No