NCT07291739

A Clinical Evaluation of a Phakic Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Staar Surgical Company · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Interventions

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

Timeline

• Start date: 2022-08-22
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Philippines