Damgaard et al., 20188
Singapore
Funding: NR | Prospective, paired-eye, single-masked, single center RCT
Analysis: PP
Sample size calculation: Yes, minimum of 63 patients (126 eyes) to have a non-inferiority limit of 0.6 in mean postoperative symptom scores, SD of 1.2, power of 80%, and significant level of 2.5%. | 70 adult patients
Mean age (SD): 28.3 (5.21) years
Sex: 36% male
Race: 96% Asian
Sphere: -9.25 D to -2.00 D
Cylinder: -2.50 D to 0.00 D
Spherical equivalent: -9.50 D to -2.0 D | Femtosecond LASIK | SMILE | Patient experience using post-operative questionnaire at 1- and 3-month follow-up
Items in the questionnaire: light sensitivity, eye discomfort, eye dryness, excessive tearing, gritty sensation, glare, halos, blurring, and fluctuation in vision.
Score: 1 to 6 (1 = not at all, 6 = very severe/extremely) |
Each patient was randomized to undergo LASIK in one eye and SMILE in the other eye in the same day performed by the same surgeon. |
Hashmani et al., 201711
Pakistan
Funding: The Hashmanis Foundation | Retrospective cohort study
Analysis: P value set at 0.05
Sample size calculation: No | 207 adult patients (409 eyes)
Mean age (SD), years
- -
LASIK: 27.0 (7.3) - -
PRK: 25.0 (5.8)
Sex
- -
LASIK: 31% male - -
PRK: 27% male
Sphere
- -
LASIK: -9.8 D to 6.8 D - -
PRK: -14.5 D to 2.0 D
Cylinder
- -
LASIK: -12.8 D to 3.3 D - -
PRK: -5.0 D to 0.25 D
Spherical equivalent
- -
LASIK: -13.4 D to 8.0 D - -
PRK: -15.5 D to 0.0 D
| Femtosecond LASIK (n = 117 patients; 229 eyes) | PRK (n = 90 patients; 180 eyes) | Patient satisfaction (overall)
Satisfaction level: “extremely satisfied”, “very satisfied”, “satisfied”, and “not satisfied”
Follow-up: post-operative (NR on time) |
PRK was performed by three surgeons; LASIK was performed by one surgeon. |
Schallhorn et al., 201712
UK
Funding: NR | Retrospective cohort study
Analysis: P value set at 0.05
Sample size calculation: No | 1,198 adults patients
Mean age (SD), years
- -
LASIK: 51.9 (3.8) - -
RLE: 54.0 (3.7)
Sex
- -
LASIK: 38.5% male - -
RLE: 50.7% male
Patient classification:
- -
Moderate to high myopia - -
Low myopia - -
Plano presbyopia - -
Hyperopia (There were some differences in baseline visual variables between patients underwent LASIK and RLE) | Monovision LASIK (n = 608) | RLE (n = 590) | Patient satisfaction using post-operative questionnaire at 1 day, 1 week, 1 month and 3 months
Six questions, score from 1 to 5 (1 = very satisfied, 5 = very dissatisfied) |
Surgeries were performed at 37 centers by 27 ophthalmologists |
Price et al., 201613
USA
Funding: NR | Prospective, longitudinal, parallel-group, multicenter survey
Analysis: P value set at 0.01
Sample size calculation: No | 1,800 adult patients
Mean age (SD), years
- -
Contact lenses continuing: 34 (12) - -
Contact lenses to LASIK: 34 (9) - -
Glasses to LASIK: 37 (11)
2/3 contact lens wearers were female
>1/2 glasses wearers were male
Age, gender and duration of contact lenses: significant differences between groups
Type of lenses were balanced between contacts groups
Mean spherical equivalent in myopic eyes and in hyperopic eyes: significant differences between groups | Contact lenses continuing (n = 694) Contact lenses to LASIK (n = 819) Glasses to LASIK (n = 287) | Patient satisfaction was assessed using survey instrument at 1, 2, and 3 years of follow-up
Components included:
- -
Overall satisfaction - -
Night-driving difficulties and night visual disturbances - -
Dry eyes - -
Artificial tear use - -
Difficulty reading small print - -
Depression - -
Infection, ulceration, and abrasion
|
Ang et al., 201514
Singapore
Funding: National Research Foundation-Funded Translational & Clinical Research Program Grant | Prospective cohort study
Analysis: P value set at 0.05
Sample size calculation: Yes
413 eyes of LASIK and 126 eyes of SMILE to achieve power of 82% to detect a difference of 0.1 in mean of efficacy index
For QIRC analysis, 17 patients in each group would achieve 80.7% power to detect a difference of 10.0 | Adult patients
Mean age (SD), years
- -
LASIK: 32 (7) - -
SMILE: 32 (8)
Sex: NR
Race (Chinese)
- -
LASIK: 82% - -
SMILE: 80%
Most patients in both groups had myopia and spherical equivalents were similar in both groups | Femtosecond LASIK (n = 688 eyes) | SMILE (n = 172 eyes) | Visual-related QoL using validated QIRC at 3-month follow-up
20 items covering visual function, symptoms, convenience, concerns, and emotional well-being.
Each item was score on 5-point response scale spaced evenly, ranging from “not at all” to “extremely” |
Hansen et al., 201515
Denmark
Funding: Odense University Hospital Research Foundation | Retrospective cohort study
Analysis: P value set at 0.05
Sample size calculation: No | 81 adult patients Mean age (SD), years
- -
LASEK: 37 (8) - -
PRK: 38 (6)
Sex: NR
Myopia
- -
LASEK: 92% - -
PRK: 97%
Sphere
- -
LASEK: -12.75 D to -1.75 D - -
PRK: -11.75 D to -3.00 D
Astigmatism
- -
LASEK: -3.00 D to 0.00 D - -
PRK: -3.00 D to 0.00
Spherical equivalent
- -
LASEK: -13.00 D to -1.75 D - -
PRK: -11.75 D to -4.50 D
| LASEK (n = 35 patients) | Cooling PRK (n = 46 patients) | Patient satisfaction assessed using two questions:
“How satisfied are you right now with your laser surgery for near-sightedness, on a scale from 0 to 10, where 10 is the most satisfied and 0 is the most dissatisfied?” “Would you recommend the surgery to a friend or relative?”
Follow-up
- -
LASEK: 5.4 to 6.7 years (average 6.0 years) - -
PRK: 4.1 to 5.0 years (average 4.6 years)
|
Nassiri et al., 20159
Iran
Funding: NR | Open-label, parallel, 1:1 ratio, single center RCT
Analysis: unclear about ITT or PP
Sample size calculation: Yes, based on difference of 0.2, SD of 0.26, and 95% confidence interval in contrast sensitivity (primary outcome) | 80 adult patients (152 eyes)
Mean age (SD): 27 (5.5) years
Sex: 23.8% male
Sphere: -6.25 D to -3.00 D
Cylinder: -1.25 D to 1.25 D
Spherical equivalent: -6.63 D to -2.88 D | Tissue-saving PRK (n = 76 eyes) | Wavefront-optimized PRK (n = 76 eyes) | Patient satisfaction using post-operative questionnaire at 3-month follow-up
- -
Ten questions on patient perception of glare, light sensitivity, hazy or foggy vision, dry eye, foreign body sensation, vision fluctuation, double vision. - -
Total satisfaction with vision (scale 1 to 10)
|
Sia et al., 201510
USA
Funding: US Army Medical Research Acquisition Activity Award | Open-label, parallel, 1:1 ratio, single center RCT
Analysis: PP
Sample size calculation: NR | 108 adult patients
Mean age (SD): 30.3 (6.3) years
Sex: 77.8% male
Spherical equivalent (SD): -3.51 (1.63) D
Sphere and cylinder were similar in both groups | Wavefront-guided PRK (n = 55 patients) | Wavefront-optimized PRK (n = 53 patients) | Patient satisfaction using post-operative questionnaire at 12-month follow-up
Items in the questionnaire: difficulty performing daily activities, dry eye, vision fluctuation, double vision, nighttime glare, halo, overall vision expectation, patient satisfaction |
Soler Tomas et al., 201516
Spain
Funding: No funding | Longitudinal, comparative case series
Analysis: P value set at 0.01
No sample size calculation | 30 adult patients (40 eyes), hyperopic presbyopes seeking independence from reading glasses
Mean age (SD): 53.5 (2.3) years for symmetrical and 51.9 (2.5) years for asymmetrical PresbyLASIK
Sex: NR
Spherical equivalent: +1 D to +2.5 D
Astigmatism: up to 1 D
Maximum difference between subjective and cycloplegic refraction: ≤ +0.5 | Symmetrical PresbyLASIK (16 patients; 19 eyes) | Asymmetrical PresbyLASIK (14 patients; 21 eyes) | Patient satisfaction using modified cataract TyPE Spec questionnaire at 18-month follow-up
- -
General satisfaction (0 to 10 points - -
Reading satisfaction (0 to 10 points) - -
Distance, near, and intermediate vision difficulties (0 to 4 points) - -
Halos difficulties (0 to 4 points) - -
Willing to repeat the procedure (0 to 4 points)
|