A Clinical Evaluation of a Phakic Intraocular Lens

NCT07291739 | Completed

• 1 other identifier: CP18-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Astigmatism; Presbyopia; Hyperopia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

EDOF ICL

OTHER

Eyes treated EVO+ Visian and EVO+ Toric Implantable collamer lens with aspheric optic determined by their preoperative refraction

Device: Implantable Collamer Lens (ICL)

Interventions

Implantable Collamer Lens (ICL) DEVICE

EVO+ Visian Implantable Collamer Lens with Aspheric (EDOF) Optic models VTICM6/VTICH6 (TEDOF ICL) and VICM6/VICH6 (EDOF ICL)

EDOF ICL

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Staar Surgical Company: lead

Study Sites (1)

Asian Eye Institute

Makati City, Philippines

Location

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: August 22, 2022
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)