An Early Phase 1 interventional study of Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively in Astigmatism and Hyperopia, sponsored by McGill University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by McGill University · Early Phase 1, Interventional, and Treatment
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.
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.
417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.
This study's enrollment of 32 is below the median of 55 across 325 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively
Planned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively
Also known as: ICL + LASIK
Post-operative visual acuitiy
postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)
Time frame: 90 days after lasik surgery
Manifest refraction
The refraction (glasses prescription required) done manually of the operated eye
Time frame: 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
Time frame: 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
Time frame: 90 days after LASIK surgery
Astigmatism Vector Analysis
The residual astigmatism left after surgery, representing the deviation from the intended correction.
Time frame: 90 days after LASIK surgery
Plan to share: No — Small study of only 32 patients, individual data will not be shared to protect patient confidentiality.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.