AstigmatismEarly Phase 1NCT06742541
ICL and LASIK for Hyperopic Astigmatism
A Early Phase 1 study testing Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively in people with Astigmatism and Hyperopia, run by McGill University at 1 site in Canada.
Trial summary
This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Hyperopia
- What is being tested?
- Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 1 Mar 2022
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative hyperopic sphere of ≥+3.50 D
- Astigmatism of ≥+2.00 D
- Stable refraction for the previous 12 months
- Age older or equal to 18 years
- Anterior chamber depth (ACD) from corneal endothelium to anterior lens capsule of 3.0 mm or greater
Who cannot join
- Age younger than 18 years
- Patients lost to follow-up
- Cataract formation
- History of glaucoma or retinal detachment
- Macular degeneration
- Diabetic retinopathy
Show all 9Show fewer
- History of ocular inflammation
- Signifcant irregular corneal topography
- Evidence of inconsistent imaging from dry eyes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spherical Implantable Collamer Lens With Postoperative Adjunctive LASIK in the Treatment of High Compound Hyperopic Astigmatism
This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Later, a laser procedure (LASIK) is performed to fine-tune the results for even better clarity.
Read the detailed description
To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism. In this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.
- Conditions
- Astigmatism, Hyperopia
- Being tested
- Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively
- Keywords
- ICL, LASIK, Hyperopia, Astigmatism
- Medical subject headings
- Astigmatism, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperativelyDevice
Also called ICL + LASIK
Planned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Patients with high compound hyperopic astigmatism | Experimental | eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism undergoing planned surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively Receives: Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative visual acuitiy
postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)
Measured: 90 days after lasik surgery
Secondary outcomes (4)
Manifest refraction
The refraction (glasses prescription required) done manually of the operated eye
Measured: 90 days after lasik surgery
Spherical (SEQ) and defocus equivalent (DEQ)
SEQ: a single value used to describe a refractive error, combining the spherical and cylindrical components of a prescription DEQ: quantifies the overall refractive blur from spherical and cylindrical components
Measured: 90 days after LASIK surgery
Efficacy Index and Safety Index
Efficacy Index: ratio of postoperative uncorrected distance visual acuity (UDVA) to preoperative corrected distance visual acuity (CDVA) Safety Index: ratio of postoperative corrected distance visual acuity (CDVA) to the preoperative CDVA
Measured: 90 days after LASIK surgery
Astigmatism Vector Analysis
The residual astigmatism left after surgery, representing the deviation from the intended correction.
Measured: 90 days after LASIK surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Li, McGill University
- Investigators
- Avi Wallerstein, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742541
- Sponsor's protocol ID
- VGC81
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Small study of only 32 patients, individual data will not be shared to protect patient confidentiality.
Publications
Li DQ, Gauvin M, Rocha G, Trottier P, Racine L, Wallerstein A. Spherical implantable collamer lens with postoperative adjunctive LASIK in the treatment of high compound hyperopic astigmatism. BMC Ophthalmol. 2025 Jan 24;25(1):44. doi: 10.1186/s12886-024-03828-5.
PubMed 39856569
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spherical Implantable Collamer Lens With Postoperative Adjunctive LASIK in the Treatment of High Compound Hyperopic Astigmatism
- ClinicalTrials.gov ID
- NCT06742541
- Acronym / sponsor ID
- VGC81
- Conditions
- Astigmatism, Hyperopia
- Keywords
- ICL, LASIK, Hyperopia, Astigmatism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Dec 2024 (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.
This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Later, a laser procedure (LASIK) is performed to fine-tune the results for even better clarity.
Detailed description
To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism. In this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with high compound hyperopic astigmatism | Experimental | Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperativelyeyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism undergoing planned surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Preoperative hyperopic sphere of ≥+3.50 D
- Astigmatism of ≥+2.00 D
- Stable refraction for the previous 12 months
- Age older or equal to 18 years
- Anterior chamber depth (ACD) from corneal endothelium to anterior lens capsule of 3.0 mm or greater
Key exclusion criteria (9 listed)
- Age younger than 18 years
- Patients lost to follow-up
- Cataract formation
- History of glaucoma or retinal detachment
- Macular degeneration
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 |
|---|---|---|
| Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperativelyAlso: ICL + LASIKPlanned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively | Device | Patients with high compound hyperopic astigmatism |
Primary outcome
Post-operative visual acuitiy
Time frame: 90 days after lasik surgery
postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)
4 secondary outcomes
Manifest refraction
Time frame: 90 days after lasik surgery
Spherical (SEQ) and defocus equivalent (DEQ)
Time frame: 90 days after LASIK surgery
Efficacy Index and Safety Index
Time frame: 90 days after LASIK surgery
Astigmatism Vector Analysis
Time frame: 90 days after LASIK surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 39856569Li DQ, Gauvin M, Rocha G, Trottier P, Racine L, Wallerstein A. Spherical implantable collamer lens with postoperative adjunctive LASIK in the treatment of high compound hyperopic astigmatism. BMC Ophthalmol. 2025 Jan 24;25(1):44. doi: 10.1186/s12886-024-03828-5.
- Individual participant dataSharing planned: No. Small study of only 32 patients, individual data will not be shared to protect patient confidentiality.
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Active, not recruiting
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
Myopia, Astigmatism
Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Astigmatism
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.
Avi Wallerstein, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively in people with Astigmatism and Hyperopia, run by McGill University 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 19 Dec 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative visual acuitiy (time frame: 90 days after lasik surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742541, which also lists 1 linked publication.
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 19 Dec 2024.