Algorithm for Vertical Placement of Implantable Collamer Lens

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.

Study Overview

• Status: Terminated
• Conditions: Myopia
• Intervention / Treatment: Device: Visian

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Abbotsford, British Columbia, Canada
      • Valley Laser Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting with myopic or myopic astigmatism, and a motivation for spectacle independence.

Description

Subjects are eligible for the study if they meet the following criteria:

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

Inclusion Criteria:

• 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:

If any of the following exclusion criteria are applicable to the subject or study eye, the subject should not be enrolled in the study.

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Implantation of the Visian ICL; Visian implantable collamer lens (ICL)	Device: Visian; Visian implantable collamer lens (ICL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vault height	Vault height at 6-months postoperatively	6 months
Cycloplegic refraction	Percentage of eyes that are within postoperative MRSE ± 0.5D	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular uncorrected distance visual acuity (Snellen)	Monocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen Chart	6 months
Binocular uncorrected distance visual acuity (Snellen)	Binocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen chart	6 months
Residual astigmatism	Residual astigmatism (as measured by manifest refraction at distance)	6 months

Collaborators and Investigators

• Sponsor: Valley Laser Eye Centre
• Collaborators: Sengi
• Investigators: Principal Investigator: John Blaylock, MD, Valley Laser Eye Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: implantable collamer lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: JB-21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes