Algorithm for Vertical Placement of Implantable Collamer Lens

Study Overview
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Brief Summary
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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
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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.

Official Title
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Algorithm for Vertical Placement of Implantable Collamer Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Visian


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implantation of the Visian ICL<br>Visian implantable collamer lens (ICL) | Device: Visian<br>* Visian implantable collamer lens (ICL)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable collamer lens