A Clinical Evaluation of a Phakic Intraocular Lens

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.

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.

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.