Dataset Information

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK^TM) Using the ELITA^(TM) Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.

ABSTRACT:

Purpose

To evaluate visual outcomes following the Smooth Incision Lenticular Keratomileusis (SILK^TM) procedure for correction of myopic refractive errors with and without astigmatism, using the ELITA^TM Femtosecond Laser System.

Patients and methods

A prospective, multicenter, single-arm, open-label clinical study was conducted. Eighty-five myopic subjects (n = 170 eyes), aged 18 years or older, with manifest refractive spherical equivalent (MRSE) up to -12.00 D and astigmatism up to -6.00 D, were treated binocularly using the ELITA femtosecond laser and followed up for 6 months. Intended correction was emmetropia for all eyes. The primary outcome measures included post-operative uncorrected and corrected distance visual acuity (UDVA and CDVA). Secondary outcome measures included surgeon's rating for ease of lenticule extraction, predictability, safety, and stability.

Results

A total of 170 eyes of 85 patients underwent SILK. Preoperative mean MRSE was -4.14 D ± 1.32 D (range -1.38 D to -8.88 D) and the mean cylinder was -0.77 D ± 0.62 D. Intraoperative surgeon ease of lenticule dissection was rated as grade 0 or 1 in 85.3% of eyes (no/only mild dissection needed). UDVA at 1 day, 1 week, 1 month, and 6 months was 20/20 or better in 65.9%, 85.4%, 91.5%, and 96% of eyes, respectively. No eyes lost any lines of CDVA at 6 months compared to the preoperative. The postoperative MRSE was stable over time, ranging from -0.34 D ± 0.24 D at 1 month to -0.33 D ± 0.23 D at 6 months. MRSE predictability (± 0.50 D) was 93.5% (129/138) at 3 months and 91.1% (113/124) at 6 months. No serious adverse events were noted.

Conclusion

The SILK procedure with the ELITA Femtosecond Laser System is safe and effective for the treatment of myopic refractive errors with and without astigmatism. Fast visual recovery was demonstrated, with stability achieved by 3 months.

SUBMITTER: Sachdev MS

PROVIDER: S-EPMC10715007 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK<sup>TM</sup>) Using the ELITA<sup>(TM)</sup> Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.

Sachdev Mahipal S MS Shetty Rohit R Khamar Pooja P Malik Raghav R Schwam Brian L BL Wang Ying Y Fu Hong H Voorhees Andrew P AP Laron Michal M

Clinical ophthalmology (Auckland, N.Z.) 20231208

<h4>Purpose</h4>To evaluate visual outcomes following the Smooth Incision Lenticular Keratomileusis (SILK<sup>TM</sup>) procedure for correction of myopic refractive errors with and without astigmatism, using the ELITA<sup>TM</sup> Femtosecond Laser System.<h4>Patients and methods</h4>A prospective, multicenter, single-arm, open-label clinical study was conducted. Eighty-five myopic subjects (n = 170 eyes), aged 18 years or older, with manifest refractive spherical equivalent (MRSE) up to -12.00 ...[more]

PMID: 38089649

Similar Datasets

Project description:PurposeThe goal of this study was to compare small incision lenticule extraction (SMILE) with femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for treating myopia.MethodsThe CENTRAL, EMBASE, PubMed databases and a Chinese database (SinoMed) were searched in May of 2016. Twelve studies with 1,076 eyes, which included three randomized controlled trials (RCTs) and nine cohorts, met our inclusion criteria. The overall quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group framework. Data were extracted and analysed at three to six months postoperatively. Primary outcome measures included a loss of one or more lines of best spectacle corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA) of 20/20 or better, mean logMAR UCVA, postoperative mean spherical equivalent (SE) and postoperative refraction within ±1.0 D of the target refraction. Secondary outcome measures included ocular surface disease index (OSDI), tear breakup time (TBUT) and Schirmer's 1 test (S1T) as dry eye parameters, along with corneal sensitivity.ResultsThe overall quality of evidence was considered to be low to very low. Pooled results revealed no significant differences between the two groups with regard to a loss of one or more lines in the BSCVA (OR 1.71; 95% CI: 0.81, 3.63; P = 0.16), UCVA of 20/20 or better (OR 0.71; 95% CI: 0.44, 1.15; P = 0.16), logMAR UCVA (MD 0.00; 95% CI: -0.03, 0.04; P = 0.87), postoperative refractive SE (MD -0.00; 95% CI: -0.05, 0.05; P = 0.97) or postoperative refraction within ±1.0 D of the target refraction (OR 0.78; 95% CI: 0.22, 2.77; P = 0.70) within six months postoperatively. The pooled analysis also indicated that the FS-LASIK group suffered more severely from dry eye symptoms (OSDI; MD -6.68; 95% CI: -11.76, -2.00; P = 0.006) and lower corneal sensitivity (MD 12.40; 95% CI: 10.23, 14.56; P < 0.00001) at six months postoperatively.ConclusionsIn conclusion, both FS-LASIK and SMILE are safe, effective and predictable surgical options for treating myopia. However, dry eye symptoms and loss of corneal sensitivity may occur less frequently after SMILE than after FS-LASIK.

Dataset Information

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK^TM) Using the ELITA^(TM) Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.

Purpose

Patients and methods

Results

Conclusion

Publications

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK<sup>TM</sup>) Using the ELITA<sup>(TM)</sup> Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILKTM) Using the ELITA(TM) Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.

Purpose

Patients and methods

Results

Conclusion

Publications

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK<sup>TM</sup>) Using the ELITA<sup>(TM)</sup> Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK^TM) Using the ELITA^(TM) Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors.