This prospective single-arm trial enrolled 48 consecutive eyes (32 patients) that underwent spherical hyperopic ICL implantation followed by planned postoperative adjunctive LASIK with the goal of full correction of high compound hyperopic astigmatism. Eyes were recruited between January 2018 and December 2021 at nine Canadian refractive surgery centres from eight surgeons. Inclusion criteria included preoperative hyperopic sphere of ≥ + 3.50 D, astigmatism of ≥ + 2.00 D, and 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 included age younger than 18 years, patients lost to follow-up, cataract formation, history of glaucoma or retinal detachment, macular degeneration, diabetic retinopathy, and a history of ocular inflammation. Patients with signifcant irregular corneal topography, or evidence of inconsistent imaging from dry eyes were also excluded. Eyes with amyblopia were not excluded if they had a CDVA of 20/40 or better.

A detailed preoperative ocular examination was performed including the CDVA, UDVA, manifest and cycloplegic refraction (performed by an ophthalmic technicain and an optometrist and repeated at least twice), tonometry, slit lamp bio-microscopy and dilated fundus examination. The anterior segment was further assessed with Placido-based and scanning slit topography (Orbscan IIz, Bausch & Lomb) and Scheimpflug corneal tomography (Pentacam HR; Oculus GmbH). Anterior segment optical coherence tomography (OCT) (Optovue, Inc) was used to assess corneal thickness and the anterior chamber angle. White-to-white measurements were obtained either with Orbscan IIz or with digital calipers.

This study was approved by the Ethics Review Board of the Canadian Ophthalmic Research Centre and fully adhered to the principles of the Declaration of Helsinki. All patients were fully informed of the nature and purpose of the procedures, and any potential risks or benefits associated with them. All patients understood the need for a secondary LASIK procedure to address remaining sphere and cylinder after ICL implantation. All patients provided a written consent for surgery which included consent for the use of anonymized data for research. This trial was retrospectively registered on ClinicalTrials.gov with the trial registration number of NCT06742541.

The Hyperopic Visian ICL V4 (STAAR Surgical, Monrovia) is a one-piece hydrophilic implant composed of a collagen and poly-hydroxyethyl methacrylate-based copolymer. It differs from the myopic versions V4c and V5 (EVO and EVO+, respectively) in that it lacks the central and peri-optic holes which facilitate aqueous humor flow. To prevent pupillary block, two laser peripheral iridotomies (LPIs) were performed on all eyes during the second preoperative visit at the 10- and 2-o’clock positions using neodymium: yttrium– aluminum–garnet (YAG) laser. In North America, the Hyperopic ICL ranges in power from + 3.00 to + 10.0 diopters and is commercially available in four sizes. The manufacturer’s online calculator (https://ocos.staarag.ch) was used to obtain the individualized ICL power and size for each eye.

Before surgery, 0.5% tetracaine (Bausch & Lomb), 5% betadine solution, and 2% xylocaine jelly (AstraZeneca Canada Inc) were given topically. Each eye was draped in a standard sterile surgical fashion, and a lid speculum was inserted. The ICL was inspected prior to loading it into the cartridge according to the manufacturer’s instructions. A 1.0 mm super-blade was used to make superior and inferior paracenteses. 1% non-preservative lidocaine was injected into the anterior chamber followed by the injection of OcuCoat Viscoelastic (Bausch & Lomb) material to fill the anterior chamber. A 2.2 mm keratome is used to create the main incision on the temporal side, subsequently enlarged with a 3.0 mm crescent knife. More viscoelastic material was injected through the main incision between the lens and the endothelium to protect the endothelium from damage, and the ICL was injected through the main incision tunnel by cartridge. The haptics of the lens were positioned posteriorly to the iris, in the ciliary sulcus, using the Batlle manipulator (#05-4060, Rhein). Once the lens was properly positioned, the viscoelastic material was removed using irrigation/aspiration. Acetylcholine chloride intraocular solution (Miochol-E, Bausch & Lomb, Bedminster, NJ, USA) was instilled to constrict the pupil. Balanced salt solution was used to fill the anterior chamber. Intracameral moxifloxacin 0.6 cc was injected (Vigamox, Alcon Canada Inc), and the wounds were properly sealed with stromal hydration. Oral acetazolamide 250 mg was given immediately postoperatively, and patients were assessed two hours after the procedure at the slit-lamp to ensure proper lens position, absence of pupillary block, and normal intraocular pressure before discharge. Postoperative eye drop prescriptions included moxifloxacin 0.5% and prednisolone acetate 1% four times a day, and bromfenac 0.09% once daily. On postoperative day 1, in addition to the routine complete eye evaluation, anterior segment OCT was performed to assess the ICL vault. Subsequent manifest refraction was determined at postoperative month 1.

LASIK treatment targeting emmetropia was performed within 3 months post ICL implantation to treat the moderate to high astigmatism remaining after spherical ICL implantation, and to address any residual sphere. The ICL power was intentionally targeted to be slightly myopic and as close to plano as possible, knowing that a subsequent myopic astigmatism ablation is more predictable than one that is mixed astigmatism. A hinged flap was created using the Hansatome Microkeratome (Bausch & Lomb) with a 9.5 mm ringor the Intralase femtosecond laser (Abbott Medical Optics Inc) with programmed 8.5 mm flap. The target flap thickness was 125 μm with microkeratome and 105 μm with femtosecond laser. The flap was lifted with a Seibel spatula and excimer centration was achieved with the auto tracker centered on the visual axis. Central pachymetry readings were obtained prior to and after flap lift to confirm flap thickness. The stromal bed was ensured to be dry, and the laser ablation was performed. A 6.5 mm optical zone and a 9 mm total ablation zone (transition zone 2.5 mm) was used. Additional surgical technique details were published previously [7]. and a standardized postoperative regimen of antibiotics and steroids was used [8].

Ophthalmic exam data was collected preoperatively, 1-month post-ICL implantation, 1-week post-LASIK, and between 1 and 12 months post-LASIK. The final follow-up date for outcome measurement was determined as the date closest to 60 days post-LASIK. This study reports the results prior to any subsequent second LASIK treatment (enhancements). Efficacy, safety, and accuracy were assessed. Standard graphs, defined by the Journal of Refractive Surgery [9, 10], were produced using mEYEstro software [11]. Astigmatism correction was assessed using Alpins vector analysis method [12], using the AstigMATIC software (Vision Group, Montreal, Quebec, Canada)[13]. Statistical analyses were conducted in MATLAB R2022a (MathWorks, Natick, Massachusetts, United States)). The Pearson correlation coefficient was used to assess the relationship between selected continuous variables. Statistical significance was set at a P value of less than 0.05 and all data were reported as mean ± standard deviation.