NCT07790965

Brief Summary

A prospective, open-labeled, single-site study of a phakic implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 22, 2026

Last Update Submit

August 25, 2026

Conditions

MyopiaAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Cumulative and Persistent Adverse Events

    Safety Population

    3 Months

Other Outcomes (12)

  • Rates of Secondary Surgical Interventions

    3 Months

  • Frequency and Proportion of Eyes With Visual Symptoms

    3 Months

  • Frequency and Proportion of Eyes With Ocular and Visual Symptoms

    3 Months

  • +9 more other outcomes

Study Arms (1)

Participants bilaterally implanted with a phakic implantable collamer lens (ICL)

EXPERIMENTAL

Participants will receive a phakic implantable collamer lens (ICL) in each eye

Device: Phakic Implantable Collamer Lens (ICL)

Interventions

Phakic Implantable Collamer Lens (ICL)DEVICE

Diffractive Trifocal Phakic ICL

Participants bilaterally implanted with a phakic implantable collamer lens (ICL)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be between the age of 21 - 60 years
  • Must be suitable for ICL surgery,
  • Must meet all unique study eligibility criteria

You may not qualify if:

  • Outside the age of 21 - 60 years,
  • Not a suitable candidate for ICL surgery,
  • Does not meet all unique study eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Gabriel Quesada Larez, MD

    Clinica Quesada SA de CV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Director, Clinical Affairs

CONTACT

336-306-0587lschall@staar.com

Jennifer Lynch

CONTACT

jlynch@staar.com

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

August 22, 2026

First Posted

August 27, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share