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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Planned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively
Vision Group Canada
Montreal, Canada
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
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