Algorithm for Vertical Placement of Implantable Collamer Lens

Myopia Clinical Trial

Official title:

Algorithm for Vertical Placement of Implantable Collamer Lens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265637
• Other study ID #: JB-21-001
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: Valley Laser Eye Centre
• Contact: Raeann Torrance
• Phone: 604-504-3937
• Email: raeann[@]vlec.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 23 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Visian
Visian implantable collamer lens (ICL)

Locations

Country	Name	City	State
Canada	Valley Laser Eye Centre	Abbotsford	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Valley Laser Eye Centre	Sengi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vault height	Vault height at 6-months postoperatively	6 months
Primary	Cycloplegic refraction	Percentage of eyes that are within postoperative MRSE ± 0.5D	3 months
Secondary	Monocular uncorrected distance visual acuity (Snellen)	Monocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen Chart	6 months
Secondary	Binocular uncorrected distance visual acuity (Snellen)	Binocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen chart	6 months
Secondary	Residual astigmatism	Residual astigmatism (as measured by manifest refraction at distance)	6 months