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Algorithm for Vertical Placement of Implantable Collamer Lens

Sponsor
Valley Laser Eye Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05265637
Collaborator
Sengi (Other)
100
Enrollment
1
Location
21.9
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Visian

Detailed Description

This study is a single-arm, clinical evaluation study of vault height and refraction, after successful bilateral 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Algorithm for Vertical Placement of Implantable Collamer Lens
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Bilateral implantation of the Visian ICL

Visian implantable collamer lens (ICL)

Device: Visian
Visian implantable collamer lens (ICL)

Outcome Measures

Primary Outcome Measures

  1. Vault height [6 months]

    Vault height at 6-months postoperatively

  2. Cycloplegic refraction [3 months]

    Percentage of eyes that are within postoperative MRSE ± 0.5D

Secondary Outcome Measures

  1. Monocular uncorrected distance visual acuity (Snellen) [6 months]

    Monocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen Chart

  2. Binocular uncorrected distance visual acuity (Snellen) [6 months]

    Binocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen chart

  3. Residual astigmatism [6 months]

    Residual astigmatism (as measured by manifest refraction at distance)

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years and Older
Sexes Eligible for Study:
All
Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

Inclusion Criteria:

  • Presenting for uncomplicated bilateral 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 both eyes

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Valley Laser Eye Centre Abbotsford British Columbia Canada

Sponsors and Collaborators

  • Valley Laser Eye Centre
  • Sengi

Investigators

  • Principal Investigator: John Blaylock, MD, Valley Laser Eye Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valley Laser Eye Centre
ClinicalTrials.gov Identifier:
NCT05265637
Other Study ID Numbers:
  • JB-21-001
First Posted:
Mar 3, 2022
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Valley Laser Eye Centre
implantable collamer lens
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Mar 3, 2022