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OpenTrials
Completed

NCT Number: NCT07291739

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Hyperopia Presbyopia Refractive Errors

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Eye Institute

Makati City, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantable Collamer Lens (ICL)

Device

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

Primary outcomes

  1. Change in visual acuity

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

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

  2. Change in refractive cylinder

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

    Change from baseline in absolute magnitude of subjective refractive cylinder

  3. Lens axis misalignment

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

    Proportion of lenses with axis misalignment compared to operative day

  4. Rotational stability

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

    Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery

  5. Compromise in visual acuity

    Time frame: 6 months postoperatively

    Clinically significant compromise in visual acuity based on subject questionnaires

Sponsors and collaborators

Lead sponsor

Staar Surgical Company

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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