Astigmatism, Hyperopia
Conditions
Keywords
ICL, LASIK, Hyperopia, Astigmatism
Brief 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. 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.
Interventions
DEVICEImplantable 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
Sponsors
McGill University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Age younger than 18 years * Patients lost to follow-up * Cataract formation * History of glaucoma or retinal detachment * Macular degeneration * Diabetic retinopathy * History of ocular inflammation * Signifcant irregular corneal topography * Evidence of inconsistent imaging from dry eyes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative visual acuitiy | 90 days after lasik surgery | postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manifest refraction | 90 days after lasik surgery | The refraction (glasses prescription required) done manually of the operated eye |
| Spherical (SEQ) and defocus equivalent (DEQ) | 90 days after LASIK surgery | 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 |
| Efficacy Index and Safety Index | 90 days after LASIK surgery | 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 |
| Astigmatism Vector Analysis | 90 days after LASIK surgery | The residual astigmatism left after surgery, representing the deviation from the intended correction. |
Countries
Canada
Outcome results
None listed