Objective: 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.
Methods: In this prospective, multi-center, multi-surgeon, single-arm trial, 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.
Results: 48 eyes had a mean sphere of 6.18 ± 1.35 D and mean cylinder of 2.69 ± 0.89 D preoperatively. After ICL and LASIK, 94% of eyes achieved a UDVA within 1 line of preoperative CDVA. Efficacy and safety indices were 0.94 ± 0.13 and 1.00 ± 0.13, respectively. We obtained near-to-emmetropia SEQ postoperatively (mean - 0.03 ± 0.43D), and the scatterplot of attempted versus achieved refractive correction revealed a predictable procedure (R = 0.89). 93.8% and 100% of eyes achieved target SEQ within 0.75 and 1.00 D. 87.5% and 100% of eyes were within 0.50 and 0.75 D of intended plano cylinder.
Conclusion: Spherical ICL with postoperative adjunctive LASIK was safe with good early visual and refractive outcomes. The combined modality is a promising approach to treating high compound hyperopic astigmatism where toric hyperopic ICL is not available.
Trial Registration: This trial was retrospectively registered on ClinicalTrials.gov with the trial registration number NCT06742541.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759412 | PMC |
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