A Clinical Evaluation of a Phakic Intraocular Lens

Staar Surgical Company47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia Hyperopia Astigmatism Presbyopia

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)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Asian Eye Institute

Makati City, Philippines

Outcomes

Primary Outcomes

Change in visual acuity

Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity

Time frame: 1 month, 3 months and 6 months postoperatively

Change in refractive cylinder

Change from baseline in absolute magnitude of subjective refractive cylinder

Time frame: 1 month, 3 months and 6 months postoperatively

Lens axis misalignment

Proportion of lenses with axis misalignment compared to operative day

Time frame: 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

Time frame: 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

Time frame: 6 months postoperatively

Data from ClinicalTrials.gov

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