Algorithm for Vertical Placement of Implantable Collamer Lens

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05265637

Enrollment

Registered

2022-03-03

Start date

2022-02-01

Completion date

2024-05-03

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

implantable collamer lens

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.

Interventions

DEVICEVisian

Visian implantable collamer lens (ICL)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

23 Years to No maximum

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026