MyopiaNCT05265637
Algorithm for Vertical Placement of Implantable Collamer Lens
An observational study of Myopia, run by Valley Laser Eye Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Visian
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 3 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- Adult, Older adult
Study population: Subjects presenting with myopic or myopic astigmatism, and a motivation for spectacle independence.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Valley Laser Eye Centre
Abbotsford British Columbia, British Columbia
About this study
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Visian
- Keywords
- implantable collamer lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisianDevice
Visian implantable collamer lens (ICL)
| Study group | Role | What they receive |
|---|---|---|
| Implantation of the Visian ICL | Visian implantable collamer lens (ICL) Receives: Device: Visian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vault height
Vault height at 6-months postoperatively
Measured: 6 months
Cycloplegic refraction
Percentage of eyes that are within postoperative MRSE ± 0.5D
Measured: 3 months
Secondary outcomes (3)
Monocular uncorrected distance visual acuity (Snellen)
Monocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen Chart
Measured: 6 months
Binocular uncorrected distance visual acuity (Snellen)
Binocular uncorrected distance visual acuity (4m) at 6 months postoperatively using a Snellen chart
Measured: 6 months
Residual astigmatism
Residual astigmatism (as measured by manifest refraction at distance)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Feb 2022
- Primary completion3 May 2024
- Study completion3 May 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Laser Eye Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- John Blaylock, MD, Principal investigator, Valley Laser Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265637
- Sponsor's protocol ID
- JB-21-001
- Status last verified
- Nov 2024
- First submitted
- 11 Feb 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm for Vertical Placement of Implantable Collamer Lens
- ClinicalTrials.gov ID
- NCT05265637
- Acronym / sponsor ID
- JB-21-001
- Conditions
- Myopia
- Keywords
- implantable collamer lens
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Valley Laser Eye CentreUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of the Visian ICL | – | Device: VisianVisian implantable collamer lens (ICL) |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting with myopic or myopic astigmatism, and a motivation for spectacle independence.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisianVisian implantable collamer lens (ICL) | Device | Implantation of the Visian ICL |
Primary outcome
Vault height
Time frame: 6 months
Vault height at 6-months postoperatively
Cycloplegic refraction
Time frame: 3 months
Percentage of eyes that are within postoperative MRSE ± 0.5D
3 secondary outcomes
Monocular uncorrected distance visual acuity (Snellen)
Time frame: 6 months
Binocular uncorrected distance visual acuity (Snellen)
Time frame: 6 months
Residual astigmatism
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Blaylock, MD principal investigator
Valley Laser Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Valley Laser Eye Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vault height (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.