Immediate Sequential Bilateral Implantable Collamer Lens Surgery Is Safe and Effective.

PURPOSE: To assess the clinical outcomes and safety profiles of patients who underwent immediate sequential bilateral phakic lens surgery. METHODS: This retrospective multicenter study included 254 consecutive patients (508 eyes) who underwent bilateral same-day Implantable Collamer Lens (ICL) (STAAR Surgical) surgery. The authors focused on 1-year postoperative clinical outcomes and adverse events. RESULTS: In the initial cohort, 176 patients (352 eyes) met inclusion criteria. Of these, 335 eyes underwent myopic ICL placement, and 17 eyes received a hyperopic ICL. Notably, 87% of eyes achieved ±0.50 diopters (D) and 95% achieved ±1.00 D of the intended refraction. One year postoperatively, 78% of eyes demonstrated optimal vaulting (250 to 750 µm), with a significant 19% reduction in vaulting observed over the 12 months (P < .001). Only minor adverse events, including early cataract formation (1 case), secondary toric ICL rotation (3 cases), and ICL exchange due to inappropriate vaulting (6 cases), were noted. CONCLUSIONS: The findings corroborate the safety and efficacy of immediate sequential bilateral phakic lens surgery and indicate its potential as a treatment option. The low incidence of minor adverse events further reinforces its favorable safety profile. [J Refract Surg. 2024;40(5):e313-e320.].

Rotational Stability After Implantation of Two Different Phakic Toric Intraocular Lenses.

PURPOSE: To compare clinical outcomes and rotational stability of the toric implantable Collamer lens (TICL) and toric implantable phakic contact lens (TIPCL). METHODS: Charts were reviewed from January 2011 to January 2023 to identify all TICLs and TIPCLs implanted by a single surgeon. Implant size was generally chosen according to the manufacturer's recommendation, but 15 TIPCLs 0.25 mm larger than recommended to increase vaulting were included. RESULTS: Eighty-four TICLs and 98 TIPCLs were identified and yielded excellent refractive and visual results in eyes with high myopic astigmatism at the last follow-up visit. No case of acute glaucoma or cataract induction was observed. In total, 15 (8.2%) rotated lenses were recorded; 2 (2.4%) TICLs and 13 (13.3%) TIPCLs (P = .013). Eyes in both groups were similar in preoperative spherical equivalent, cylinder, white-to-white distance, anterior chamber depth (ACD), anterior chamber angle, and mean follow-up times (P = .925, .673, .822, .794, .358, and .873, respectively). Average TICL size was larger than TIPCL size (P < .001). Rotation of the lenses was positively correlated with cylinder and negatively correlated with ACD but not with vaulting (P = .001, r = 0.253; P = .011, r = -0.193; P = .488, r = -0.057; respectively). Vaulting was positively correlated with preoperative ACD (P ≤ .001, r = .329). In eyes with a rotated TIPCL, preoperative cylinder was higher and ACD was shallower than in eyes with a stable TIPCL (P = .001 and .007, respectively). Increasing the implant size had no significant effect on rotation rate (P = .685). CONCLUSIONS: Although both implants were safe and effective in highly myopic eyes, TICL rotated less frequently than TIPCL and required fewer secondary interventions. Rotation was correlated with preoperative cylinder and ACD but not lens vaulting. [J Refract Surg. 2023;39(7):463-472.].

Postoperative vault prediction for phakic implantable collamer lens surgery: LASSO formulas.

PURPOSE: To develop and evaluate reliable formulas for predicting postoperative vault more accurately after implantable collamer lens (ICL) surgery in a White patient population with varying degrees of ametropia. SETTING: Private clinical practice. DESIGN: Retrospective analysis on dataset split into a separate training and test set. METHODS: 115 eyes of 59 patients were used to train regression models predicting postoperative vault based on anterior segment optical coherence tomography (OCT) parameters (Least Absolute Shrinkage and Selection Operator [LASSO]-OCT formula), ocular biometry data (LASSO-Biometry formula), or data from both devices (LASSO-Full formula). The performance of these models was evaluated against the manufacturer's nomogram (Online Calculation and Ordering System [OCOS]) and Nakamura 1 (NK1) and 2 (NK2) formulas on a matched separate test set of 37 eyes of 19 patients. RESULTS: The mean preoperative spherical equivalent was -5.32 ± 3.37 (range: +3.75 to -17.375 diopters). The mean absolute errors of the estimated vs achieved postoperative vault for the LASSO-Biometry, LASSO-OCT, and LASSO-Full formulas were 144.1 ± 107.9 µm, 145.6 ± 100.6 µm, and 132.0 ± 86.6 µm, respectively. These results were significantly lower compared with the OCOS, NK1, and NK2 formulas ( P < .006). Postoperative vault could be estimated within 500 µm in 97.3% (LASSO-Biometry) to 100% of cases (LASSO-OCT and LASSO-Full). CONCLUSIONS: The LASSO suite provided a set of powerful, reproducible yet convenient ICL sizing formulas with state-of-the-art performance in White patients, including those with low to moderate degrees of myopia. The calculator can be accessed at http://icl.emmetropia.be .

Refractive surgery beyond 2020.

Refractive surgery refers to any procedure that corrects or minimizes refractive errors. Today, refractive surgery has evolved beyond the traditional laser refractive surgery, embodied by the popular laser in situ keratomileusis or 'LASIK'. New keratorefractive techniques such as small incision lenticule extraction (SMILE) avoids corneal flap creation and uses a single laser device, while advances in surface ablation techniques have seen a resurgence in its popularity. Presbyopic treatment options have also expanded to include new ablation profiles, intracorneal implants, and phakic intraocular implants. With the improved safety and efficacy of refractive lens exchange, a wider variety of intraocular lens implants with advanced optics provide more options for refractive correction in carefully selected patients. In this review, we also discuss possible developments in refractive surgery beyond 2020, such as preoperative evaluation of refractive patients using machine learning and artificial intelligence, potential use of stromal lenticules harvested from SMILE for presbyopic treatments, and various advances in intraocular lens implants that may provide a closer to 'physiological correction' of refractive errors.

Bilateral Implantation of a New Refractive Multi-Segmented Multifocal Intraocular Lens in Cataract or Refractive Lens Exchange Patients.

PURPOSE: To evaluate the safety and efficacy of a new multi-segmented refractive multifocal intraocular lens (IOL) after phacoemulsification and refractive lens exchange (RLE). PATIENTS AND METHODS: In this prospective, multicenter clinical trial, 63 presbyopic subjects who had cataract or where RLE candidates were bilaterally implanted with the Precizon Presbyopia IOL (Ophtec BV, Groningen, the Netherlands) after phacoemulsification. The study was conducted at 6 clinical centers in Germany, the Netherlands, Belgium, Turkey and Spain. Subjects were evaluated at baseline and at 1 day, 1 week, 1 and 3 months postoperatively for monocular and binocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity (DCIVA), uncorrected (UNVA), corrected (CNVA) and distance-corrected near visual acuity (DCNVA), contrast sensitivity and quality of vision. RESULTS: Three months postoperatively, binocular UDVA and CDVA of ≥20/40 was achieved in 98.4% (60/61) and 100%, respectively. Binocular UIVA and DCIVA of ≥20/40 was achieved in 96.7% (59/61) and 93.4% (57/61) respectively. Binocular UNVA, CNVA and DCNVA of ≥20/40 was achieved in 93.4% (57/61), 98.4% (60/61) and 95% (57/60) subjects, respectively. Complete spectacle independence was achieved in 80% (49/61) patients; 93% of patients reported that they were quite or very satisfied with the outcomes of the procedure. CONCLUSION: Precizon Presbyopia IOL implantation is a safe and effective method to provide good visual acuity at all distances in presbyopic and cataract patients.

Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia.

PURPOSE: To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia. DESIGN: Prospective multicenter study. METHODS: Presbyopic subjects who required an EDOF ICL in the range of -0.50 D to -18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire. RESULTS: A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR -0.01 ± 0.05 (20/20), -0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision. CONCLUSION: This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.

Custom-designed toric phakic intraocular lenses to correct high corneal astigmatism.

PURPOSE: To analyze the results of a custom-designed posterior chamber toric phakic intraocular lens (PIOL). METHODS: A 40-year-old woman with high astigmatism and thin corneas underwent bilateral PIOL implantation with the toric Implantable Collamer Lens (ICL) custom-designed and manufactured by STAAR Surgical. The appropriate toric ICL power was calculated to be -8.00 +8.00 x 96 degrees for the right eye and -8.50 +7.50 x 86 degrees for the left eye. Optical zone was 5.5 mm and 6.875 mm at the corneal plane. RESULTS: At 3 and 6 months postoperatively, uncorrected visual acuity (UCVA) and best-spectacle corrected visual acuity (BSCVA) of both eyes had improved to 20/20 and 20/16, respectively. At 19 months, UCVA was 20/20 and 20/16 in the right and left eyes, respectively, and BSCVA had improved to 20/16 and 20/10, respectively. The subjective refraction was stable, with a change of -0.37 +/- 0.17 D from preoperative to 19 months postoperatively. Throughout the postoperative period, iridotomies remained patent and the corneas were clear. CONCLUSIONS: Bilateral implantation of the custom-designed toric ICL successfully corrected the patient's high astigmatism. Preoperative subjective refractive cylinder of -5.25 x 6 degrees in the right eye and -5 x 176 degrees in the left eye changed to -0.5 x 77 degrees and -0.5 x 115 degrees, respectively, after toric IOL implantation. There was almost no change in corneal astigmatism. This customized approach led to UCVA of 20/20 in the right eye and 20/16 in the left eye, and BSCVA of 20/16 in the right eye and 20/10 in the left eye. This is the first report of a toric PIOL being specifically manufactured to meet the refractive cylinder requirements of a specific patient.

Pupil dilation dynamics with an intracameral fixed combination of mydriatics and anesthetic during cataract surgery.

PURPOSE: To compare the pupil dynamics of an intracameral combination of 2 mydriatics and 1 anesthetic (Mydrane) to a standard topical regimen for cataract surgery. SETTING: Sixty-two centers in Europe and 6 centers in Algeria. DESIGN: Prospective case series. METHODS: Pupil size measurements were performed in 2 randomized studies (phase 2 and phase 3) under masked conditions (recorded videography, masked reading center). The outcomes in the phase 2 study supported evaluation of the timeframe to obtain pupil dilation and the phase 3 study provided results on mydriasis stability. RESULTS: Phase 2 and phase 3 comprised 139 patients and 591 patients, respectively. After intracameral combination administration, 95% of the pupil dilation was achieved within a mean of 28.6 seconds ± 4.6 (SD). At the beginning of capsulorhexis creation, the mean pupil diameter was larger than 7.0 mm in both groups. The intraoperative pupil diameter remained stable in the intracameral combination group and decreased in the topical group. The mean change in pupil size just before capsulorhexis to the end of surgery (just before cefuroxime injection) was -0.22 ± 0.72 mm and -1.67 ± 0.98 mm, respectively. No clinically significant change in pupil diameter (change <1.0 mm) occurred in the majority of the intracameral combination group (89.3%) compared with the topical group (26.8%). CONCLUSIONS: Intracameral combination of 2 mydriatics and 1 anesthetic is an alternative to topical mydriatics for cataract surgery. The prompt onset of pupil dilation and the stable mydriasis induced by this drug combination improved the intraoperative conditions during crucial steps, such as intraocular lens implantation.

Toric phakic implantable collamer lens for correction of astigmatism: 1-year outcomes.

PURPOSE: The purpose of this study was to assess predictability, efficacy, safety and stability in patients who received a toric implantable collamer lens to correct moderate to high myopic astigmatism. METHODS: Forty-three eyes of 23 patients underwent implantation of a toric implantable collamer lens (STAAR Surgical Inc) for astigmatism correction. Mean spherical refraction was -4. 98 ± 3.49 diopters (D) (range: 0 to -13 D), and mean cylinder was -2.62 ± 0.97 D (range: -1.00 to -5.00 D). Main outcomes measures evaluated during a 12-month follow-up included uncorrected visual acuity (UCVA), refraction, best-corrected visual acuity (BCVA), vault, and adverse events. RESULTS: At 12 months the mean Snellen decimal UCVA was 0.87 ± 0.27 and mean BCVA was 0.94 ± 0.21, with an efficacy index of 1.05. More than 60% of the eyes gained ≥1 line of BCVA (17 eyes, safety index of 1.14). The treatment was highly predictable for spherical equivalent (r(2) = 0.99) and astigmatic components: J(0) (r(2) = 0.99) and J(45) (r(2) = 0.90). The mean spherical equivalent dropped from -7.29 ± 3.4 D to -0.17 ± 0.40 D at 12 months. Of the attempted spherical equivalent, 76.7% of the eyes were within ±0.50 D and 97.7% eyes were within ±1.00 D, respectively. For J(0) and J(45), 97.7% and 83.7% were within ±0.50 D, respectively. CONCLUSION: The results of the present study support the safety, efficacy, and predictability of toric implantable collamer lens implantation to treat moderate to high myopic astigmatism.