SPS-104 Refractive Procedure Outcomes: SMILE, SMILE & CXL, ICL | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in This Session
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Long-Term Clinical Outcomes of Small Incision Lenticule Extraction with Accelerated Corneal Cross-Linking(SMILE Xtra): 2-Year Results
Author
Sung Min Kim, MD

Purpose
To evaluate 2-year efficacy, safety and predictability of SMILE Xtra in patients with abnormal topography, low residual stromal bed(RSB) thickness, higher refractive error and thin pre-operative central corneal thickness(CCT). Also, to find out the safety and clinical effect of Xtra energy protocol in different patient subgroups.

Methods
Patients with moderate risk according to the Randleman ectasia score who had undergone SMILE Xtra from March 2016 to March 2017 were collected and retrospectively reviewed. Study group was divided into 4 subgroups and clinical outcomes were analyzed(group A;abnormal topography, group B;RSB thickness<300um, group C;spherical equivalent>-9.5D or lenticule thickness>130um, group D;pre-operative CCT<510um). For Xtra protocol, 90 seconds of 0.25% Rivoflavin soaking followed by 60 seconds of UV-A radiation of 30mW/cm2 was done. Uncorrected distant visual acuity, corrected distant visual acuity, manifested refraction, topography and specular microscopy were checked pre and postoperatively.

Results
Pre-operative mean spherical equivalent(SEQ) was -7.01±2.03D and mean CCT was 535.3±28.1um for SMILE Xtra patients. Post-operative visual acuity of SMILE versus SMILE Xtra at day 1 was 0.94±0.15 versus 0.80±0.22, however, it was 1.12±0.22 versus 1.08±0.21 at 2-year. Efficacy index was comparable(1.16 versus 1.13). Safety index for SMILE Xtra group was 1.16, and it showed good predictability(R2= 0.985). Mean endothelial cell count difference before and after SMILE Xtra with 1.8J/cm2 energy protocol was 45.6±121.1 but there was no statistical significance. Comparison of visual and refractive outcomes showed no significant differences within subgroups.

Conclusion
Long-term visual outcomes of SMILE Xtra showed comparable results. Safety or predictability was not affected by combined crosslinking with 1.8J/cm2 energy protocol. Different subtype characteristics did not affect the final clinical results. Thus, SMILE with accelerated cross-linking may be an effective and safe strategy for moderate risk patients.
Two Different Phakic Posterior Chamber IOLs for the Correction of Myopia or Myopic Astigmatism: Safety and Efficacy
Authors
Suphi Taneri, MD
Anika Rost, MSc
Caroline Hansson, MSc
Saskia Kießler, MSc
H. Burkhard Dick, MD, PhD

Methods
Observational consecutive case series. Inclusion criteria: myopic and myopic astigmatic eyes with implantation of spherical or toric monofocal IPCL V 2.0 or ICL V 4.0 for full correction in which high myopia and / or corneal conditions have excluded a laser-based refractive procedure. Exclusion criteria: Internal anterior chamber depth <2.8 mm, central endothelial cell count < 2000/cm2. One hundred-nineteen eyes were included (43 eyes IPCL).

Results
No adverse events except postoperative pressure spikes occurred within the first 3 months. At 3 months, mean spherical equivalent refraction was +0.06+/-0.38 D (range: -0.63 to +1.25 D) after IPCL implantation and +0.06+/-0.44 D (range: -1.13 to +1.88 D) after ICL implantation. Mean cylinder was -0.38 +/- 0.44 D (range: 0 to -2.75D) and -0.38+/-0.41 D (range: 0 to -1.75 D) with IPCL and ICL, respectively. Mean uncorrected distance visual acuity (UDVA) was 1.13 (decimal scale) and 1.04 with ICPL and ICL, respectively. Mean efficacy index was 1.13 and 1.04 with IPCL and ICL, respectively. Mean safety index was 1.28 and 0.89 with IPCL and ICL, respectively.

Conclusion
We found equally good visual and refractive outcomes with IPCL and ICL for the correction of high and moderate myopia with or without astigmatism. There is no need for nomogram adjustment when transitioning from ICL to IPCL. However, longer follow-up is warranted to determine stability of results and possible long-term adverse events.
U.S. Military Posterior Chamber Phakic Intraocular Lens Surgical Outcomes: An 11 Year Retrospective Review
Authors
Kyle T. Packer, MD
David Greenburg, MD, MPH, ABO
Anton Vlasov, DO, ABO
Andrew Coggin, MD
James W. Weightman, MD, ABO
John S. Klaric, PhD
Robert B. Carroll, MD

Purpose
To examine the long-term efficacy and safety of the Implantable Collamer Lens (ICL) in a military population.

Methods
We present a retrospective longitudinal observational study of 2,956 eyes of patients 18-55 years old who underwent ICL implantation at a single US Military medical treatment facility, followed for up to 11 years. All patients received a standard preoperative refractive surgery exam including visual acuity, IOP, manifest and cycloplegic refractions, corneal topography, corneal tomography, qualitative grading of perceived ectatic risk, ophthalmic biometry, and baseline endothelial cell counts. Postoperative measures included visual acuity, IOP, vault size, manifest refraction, and ECC. Long term follow-up data was drawn from the US Military electronic medical record system.

Results
Patients received ICLs either due to abnormal topography (68%) or due to high myopia (32%). Close to 80% of eyes maintained UCVA of 20/25 of better up to 8 years postoperatively. Predictability of achieving the desired refractive correction was 97% at one year and 90% at eight years. Stability of these outcomes was also shown by minimal change in patients’ refraction. Documented mean ECC loss was 22% at post-operative year five. Over eleven years, the overall rate of adverse events was 1.2% including visually significant cataract formation, glaucoma, retinal detachment, and traumatic incision opening. Of implanted ICLs, 4.5% were removed and/or replaced typically due to low vaults.

Conclusion
ICL implantation was found to be effective, predictable, stable, and safe. Vault sizes decreased over time suggesting an increased risk of cataract formation after seven years. A decrease in mean ECC of 22% at postoperative year five suggests further study is necessary to assess long term clinical significance.
A Five Year Analysis of Clinical Outcomes and Endothelial Cell Density Following Collamer Intraocular Lens Implantation in a Single Centre
Author
Terence McSwiney, BM BCh

Purpose
To describe the patient demographics, endothelial cell(EC) loss and treatment outcomes following phakic collamer intraocular lens(IOL) implantation in a single centre.

Methods
A retrospective review of all patients treated for refractive correction with implantation of STAAR phakic collamer IOL between January 2014 and December 2018 at the Mater Private Hospital, Dublin, Ireland was performed.

Results
91 patients and 170 eyes were included for analysis. Mean age was 34.86+-8.74 years. 66% of patients were female and mean follow up was 1.87 years(range 0.1–4.94). Mean preop anterior chamber depth was 3.73+-0.3 mm. Mean preop spherical equivalent(SE) refraction was –9.79+-3.98 Dioptres(D).Mean SE of implanted IOL was -10.52+-3.73D. 55.3% of implanted IOLs were toric.Mean decimal VA at final visit was 0.06+-0.11. Mean EC density at preop assessment was 2836+-177 cells/mm2 and at final review 2739+-201 cells/mm2 with an average loss of 95 cells/mm2. One patient required bilateral IOL explanation due to symptoms of glare. No patient required explantation of IOL due to EC density loss concerns.

Conclusion
In this case series, collamer IOL implantation was noted for its excellent visual outcomes and maintenance of corneal endothelial cell density in patients unsuitable for refractive laser surgery.
Patient Outcomes Following Raindrop Corneal Inlay Removal with or without Concomitant LASIK Treatment
Authors
Alisha A. Ho
Pamela B. Ribeiro
Samir A. Melki, MD, PhD
Jason E. Brenner, MD

Purpose
This case series seeks to evaluate the vision and refractive outcomes of patients who sought Raindrop corneal inlay removal with or without concomitant LASIK treatment.

Methods
This study utilizes a case series design and retrospective data review of electronic medical records from a private ophthalmology clinic in Boston, MA. 20 patients who had a Raindrop inlay placed and subsequently removed were identified. To be included in the study, patient records must include vision and refraction measurements from 1) before Raindrop inlay placement, 2) before Raindrop inlay removal, and 3) at least 1 month after Raindrop inlay removal. 14 patients with the necessary records were included in the study*. Of these 14 patients, 7 had Raindrop inlays removed and the remaining 7 had Raindrop inlays removed with concomitant LASIK treatment. (*NOTE: At time of 10/20/19 deadline)

Results
13 out of the 14 total patients had a best corrected distance vision of 20/20 or better prior to inlay placement. This study found that 9 out of these 14 patients had experienced a loss of at least 1 line of best corrected distance vision by the time of inlay removal. Inlay removal was performed at a mean of 494 days, or approximately 16 months, after placement. After inlay removal, 6 out of the 9 patients that sustained a loss of 1 or more lines of best corrected distance vision experienced an improvement in this vision. In patients receiving LASIK at or after time of inlay removal, we found the refractive outcome was close to target in most cases.

Conclusion
Best corrected distance vision improves with corneal inlay removal and simultaneous LASIK is successful in achieving monovision as an alternative treatment for presbyopia.
Visian Toric Implantable Collamer Lens: 1 Year Follow-up
Author
Erik L. Mertens, MD

Purpose
To evaluate the predictability, stability, safety, and efficacy of the Toric V4c Visian Implantable Collamer Lens (ICL) with central hole to correct moderate to high astigmatism.

Methods
Sixty five (65) eyes of 40 patients were evaluated after implantation of the toric V4c ICL. The refraction, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), vault, and adverse effects were evaluated throughout 12-months.

Results
The mean spherical equivalent dropped from -6.30 ± 3.79 D (Diopters) preoperatively to -0.15 ± 0.32 D postoperatively, with 90.8% eyes being within ±0.50 D of the desired refraction. The mean refractive cylinder components dropped from J0 = 0.67 ± 0.82 D to J0 = 0.06 ± 0.13 D, and J45 = 0.12 ± 0.65 D to J45 = -0.01 ± 0.15 D. At 12-months, the mean logMAR BCVA was -0.03 ± 0.04, the mean logMAR UCVA was -0.03 ± 0.04, and 36.9 % of eyes gained 1 or more lines of BCVA. Safety and efficacy indexes (with decimal visual acuities) were 1.07 and 1.06, respectively. No intraoperative complications were reported. Two ICLs required an exchange because their length were too short.

Conclusion
The visual and refractive outcomes were very good and highly stable throughout the follow-up period, showing that this toric ICL model may be predictable, stable, safe, and effective to correct moderate to high astigmatism.
Long-Term Clinical Outcomes of V4c ICL Implantation Using Swept-Source Anterior Segment OCT for Pre-Operative Internal Measurement
Author
Sung Min Kim, MD

Purpose
To assess long-term clinical outcomes of Visian implantable collamer lens(ICL) V4c implantation based on internal measurement using swept-source Fourier-domain anterior segment optical coherence tomography(AS-OCT).

Methods
Patients who underwent V4c ICL implantation from June, 2018 to December, 2018 and completed 6 month follow-up in Nunemiso Eye Clinic have been collected. Six-month clinical outcomes of 388 eyes of 195 subjects were analyzed. ICL size for implantation was determined by internal measurement using swept-source AS-OCT(CASIA2). Anterior chamber values with other modalities including Pentacam HR, Gallilei G4 and IOL master 500 were also measured pre-operatively and compared with that of CASIA2.

Results
Mean pre-operative myopia, astigmatism and axial length for the study group was -7.2±2.7D, -1.6±1.0D and 26.58±1.17mm, respectively. Mean post-operative ICL vaulting at 6-month post-op. was 519.0±159.9um. Considering the stable vaulting range from 250um to 750um, percentage of the low vault was 4.4%(17 eyes) and high vault was 5.7%(22 eyes). ICL exchange was done in 2 cases(0.51%) due to excessively low(<150um) or high(>1000um) vault. Angle-to-angle measurement by CASIA2 was not significantly different with white-to-white(WTW) measurement by Pentacam HR. However, it showed significant differences with WTW values by Gallilei G4 or IOL master 500(p<0.05).

Conclusion
High accuracy for the stable lens vaulting would be expected with swept-source AS-OCT based ICL implantation. Also, pre-op. analysis of anterior chamber values by CASIA2 could reduce complications and re-operation rates. Thus, high-resolution, fast scanning nature of CASIA2 offers predictable and safe results for the ICL surgery with convenience.
Small Incision Lenticule Extraction, Two-Year Outcomes
Authors
Kathleen J Jee, MD
William F. Wiley, MD
Shamik Bafna, MD
Jeffrey M. Augustine, OD

Purpose
To evaluate the visual outcomes of patients undergoing small incision lenticule extraction (SMILE) with stratification of results pre- and post-FDA astigmatism approval, after which the laser power settings on the Visumax (Carl Zeiss) femtosecond laser platform were lowered.

Methods
A retrospective chart review of 120 consecutive eyes of 60 patients (with an anticipated 336 consecutive eyes of 168 patients in total) who underwent SMILE at two centers from 2017-2019. Visual outcomes were assessed at post-operative day 1, month 1, and month 3, and further compared between pre- and post-astigmatism approval, where laser power settings were decreased. Enhancement rates were also measured.

Results
At post-operative day 1, 49% of patients had uncorrected visual acuity (UCVA) of 20/20 or better following SMILE, 40% of whom were prior to the laser update compared to 72% of whom were after the update. At post-operative month 3, 79% of patients had UCVA 20/20 or better, 73% of whom were prior to the laser update compared to 83% of whom were after the laser update. Enhancement rate measurements are pending.

Conclusion
Following the Visumax laser power setting update in October 2018, more SMILE patients gained 20/20 UCVA at post-operative day 1 and month 3. Surgeon learning curve may also have contributed to these improved visual outcomes.
Toric Implantable Collamer Lenses: Early United States Experience
Authors
Brett H Mueller II, DO, PhD
Bobby Saenz, OD
Noelle Abraham
Christopher M. Cavazos
Gregory D. Parkhurst, FACS, MD

Purpose
In late 2018, the FDA approved the toric implantable collamer lens (toric ICL, STAAR surgical). This new ICL platform offers patients another refractive surgical option for patients with myopic astigmatism. This clinical study aimed to evaluate the clinical outcomes of 120 Visian Toric ICLs implanted at Parkhurst Nuvision in San Antonio, TX.

Methods
This retrospective study evaluated 120 eyes of 62 patients with spherical equivalents of -8.11 ± 2.59 (mean +/- SD) and astigmatism of -2.40 ± 1.06 who underwent toric ICL implantation. Mean sphere, cylinder, spherical equivalent (SE) refraction, uncorrected visual acuity (UCVA), and best-corrected visual acuity (BCVA) were measured preoperatively and at the 1 day and 1-month visit.

Results
At day one, 93% of eyes achieved a visual acuity of 20/40 or better and 75% of eyes achieved a visual acuity of 20/25 or better. At 1 month, 86.7% of eyes achieved an UCVA of 20/25 or better and 1.6% of eyes had an UCVA that was 20/40 or worse. At the 1-month post-operative visit, the average spherical equivalent was -0.25 ± 0.58 (mean +/- SD) and the average residual astigmatism was -0.76 ± 0.51. Two eyes needed an enhancement with laser vision correction, 3 eyes needed to have their ICL rotated, and 1 eye needed to have their ICL replaced for a larger size. No vision-threatening complications occurred during the post-operative period.

Conclusion
This retrospective analysis of 1-month outcomes suggests that the Visian Toric ICL implantation in patients with myopic astigmatism provides a safe surgical procedure with excellent refractive and visual outcomes. Further studies are needed to evaluate the long-term results.

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