Clinical trial NCT05265637: Algorithm for Vertical Placement of Implantable Collamer Lens
Official title: Algorithm for Vertical Placement of Implantable Collamer Lens
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myopia
Keywords: implantable collamer lens
Lead sponsor: Valley Laser Eye Centre
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-03-03
Enrollment: 14
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting with myopic or myopic astigmatism, and a motivation for spectacle independence.

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.

Eligibility 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.

Primary outcomes:
measure: Vault height
timeFrame: 6 months
measure: Cycloplegic refraction
timeFrame: 3 months
Secondary outcomes:
measure: Monocular uncorrected distance visual acuity (Snellen)
timeFrame: 6 months
measure: Binocular uncorrected distance visual acuity (Snellen)
timeFrame: 6 months
measure: Residual astigmatism
timeFrame: 6 months
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Valley Laser Eye Centre
state: British Columbia
Study officials:
affiliation: Valley Laser Eye Centre
name: John Blaylock, MD
role: PRINCIPAL_INVESTIGATOR
References: