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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively | Device | Planned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative visual acuitiy | postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA) | 90 days after lasik surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Manifest refraction | The refraction (glasses prescription required) done manually of the operated eye | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avi Wallerstein, MD | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Group Canada | Montreal | H3B 4W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39856569 | Derived | 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. |
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Small study of only 32 patients, individual data will not be shared to protect patient confidentiality.
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| 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 | 90 days after LASIK surgery |
| Astigmatism Vector Analysis | The residual astigmatism left after surgery, representing the deviation from the intended correction. | 90 days after LASIK surgery |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |