Algorithm for Vertical Placement of Implantable Collamer Lens

NCT ID: NCT05265637

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-05-03

Brief Summary

The objective is to develop and evaluate an algorithm for implantable collamer lens (ICL) sizing that uses high frequency ultrasound biomicroscopy (UBM) for vertical placement.

Detailed Description

This study is a single-arm, clinical evaluation study of vault height and refraction, after successful ICL implantation. Subjects will be assessed pre-operatively, operatively, at 1 week postoperatively, and 1, 3, and 6 months post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and vault height.

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Implantation of the Visian ICL

Visian implantable collamer lens (ICL)

Visian

Intervention Type: DEVICE

Visian implantable collamer lens (ICL)

Interventions

Visian

Visian implantable collamer lens (ICL)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Note: Ocular criteria must be met in each study eye.

• Presenting for uncomplicated ICL implantation, either toric or non-toric lens, with vertical placement of the ICL
• Gender: Males and Females.
• Age: 23 or older.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
• Potential postoperative visual acuity of (20/25 Snellen) or better in the study eye

Exclusion Criteria

• Irregular astigmatism (e.g. keratoconus)
• Unstable refractive error
• Low endothelial cell count
• Anterior chamber depth <2.8mm
• Any cataract in operative eye or nontraumatic cataract in the fellow eye
• Narrow anterior chamber angles (Grade 2 or less)
• Difficulties comprehending written or spoken language
• Patient with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate)
• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
• Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

• Minimum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Valley Laser Eye Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Blaylock, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Laser Eye Centre

Locations

Valley Laser Eye Centre

Abbotsford, British Columbia, Canada

Countries

Canada

Other Identifiers

JB-21-001

Identifier Type: -

Identifier Source: org_study_id