Algorithm for Vertical Placement of Implantable Collamer Lens

Valley Laser Eye Centre

Status

Terminated

Conditions

Myopia

Treatments

Device: Visian

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05265637

JB-21-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

23+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.