Single-Step Transepithelial PH

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Xi et al.

BMC Ophthalmology (2018) 18:209


https://doi.org/10.1186/s12886-018-0888-x

RESEARCH ARTICLE Open Access

Single-step Transepithelial photorefractive


keratectomy in the treatment of mild,
moderate, and high myopia: six month
results
Lei Xi1, Chen Zhang2 and Yanling He3*

Abstract
Background: To evaluate the safety, efficacy, and the refractive outcomes of single-step transepithelial photorefractive
keratectomy (TransPRK) for the correction of mild, moderate, and high myopia.
Methods: This study consecutively recruited 32 high myopic eyes, 32 mild myopic and 32 moderate myopic eyes. Eyes
with myopia that had undergone TransPRK treatment. Pre- and post-operative visual and refractive data, corneal Higher
Order Aberration (HOA) as well as safety and efficacy indices were analyzed at 6 months postoperatively.
Results: Six months after TransPRK, the manifest refraction spherical equivalent (SE) was not significantly between high
myopia group and moderate myopia group (p = 0.636). No eyes lost ≥2 lines of corrected distant visual acuity (CDVA) in
high myopic eyes. The uncorrected distance visual acuity (UDVA) was significantly higher in low and moderate myopia
groups than the high myopia group (P < 0.001; P = 0.002). The CDVA was not significantly different between moderate
and high myopia groups (P = 0.057). There was no significant difference in mean safety index between high myopia
group (1.01 ± 0.14) and mild myopia group (1.08 ± 0.15) (P > 0.05). The mean safety index was significantly higher in the
moderate myopia group (1.16 ± 0.23) than in the high myopia group (1.01 ± 0.14) (P = 0.002). The efficacy index was
significantly higher in the moderate myopia group (1.05 ± 0.20) than in the high myopia group (0.89 ± 0.17) (P = 0.02),
and there was no significant difference between the high myopia group (0.89 ± 0.17) and the low myopia
group (0.96 ± 0.16) (P = 0.14).
Conclusions: The mean safety index was over 1.0 in the three groups. TransPRK showed acceptable safety and efficacy
in the moderate myopic eyes, as well as mild and high myopic eyes. High myopic eyes got very similar refractive
results with moderate myopic eyes six months postoperatively. The safety and efficacy indexes were not significantly
different between the high myopia group and the low myopia group.
Keywords: Transepithelial photorefractive keratectomy, Myopia, TransPRK

Background advantages include flap free, minimal trauma to the eye


Transepithelial photorefractive keratectomy (TransPRK) and without flap-related complications [1]. Moreover,
is becoming increasingly popular in the treatment of the corneal biomechanics are less affected than other re-
myopia. TransPRK has a higher laser cutting frequency fractive procedures, including Small Incision Lenticule
than traditional PRK. The unique feature of this tech- Extraction (SMILE) [2]. Also it allows reoperation. Previ-
nique is that it removes the corneal epithelium and ous studies have demonstrated that TransPRK is safe,
stroma in a single step with one ablation profile. Its predictable and effective in the correction of myopia and
myopic astigmatism [3–6]. A study showed that
* Correspondence: heyanling2002@sohu.com
TransPRK and femtosecond-assisted laser in situ kerato-
3
Department of Ophthalmology, Peking University People’s Hospital, mileusis (LASIK) share similar refractive outcomes in
Xizhimen South Street 11, Xi Cheng District, Beijing 100044, China myopia correction [7]. Another study found that
Full list of author information is available at the end of the article

© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Xi et al. BMC Ophthalmology (2018) 18:209 Page 2 of 8

TransPRK using SmartPulse Technology (SPT) provides using ORK-CAM software. For each treatment, the
significant accelerated healing and visual rehabilitation epithelium thickness profile that 55 μm centrally and
than without SPT [8]. However, there is a lack of com- 65 μm peripherally based on the population statistic.
parative data on the safety, efficacy and refractive out- The target refraction was emmetropia in all eyes.
comes between low to moderate myopic eyes and high After surgery, the cornea was irrigated with a cool
myopic eyes after TransPRK surgery. balanced salt solution and a soft bandage contact lens
This prospective clinical study evaluated the early was applied for three to four days. Patients were
visual acuity, refractive error and efficacy outcomes of instructed to use 0.5% levofloxacin (Cravit; Santen,
TransPRK in different ranges of myopic eyes with low Inc.) four times a day for one week and 0.1% fluoro-
(< 2D) astigmatism. metholone (Allergan, Inc.) eye drops four times a day,
then tapered progressively over the following four
Methods months.
Patient population and study design
This study enrolled patients consecutively between Safety and efficacy
October 2016 and March 2017 at the Department of Oph- The safety index is defined as the ratio of postoperative
thalmology at Peking University. Patients were divided CDVA/preoperative CDVA. The efficacy index is defined
into three groups: low myopia (≤ − 3.00D), moderate as the ratio of postoperative UDVA/preoperative CDVA.
myopia (− 3.00D to − 6.00D) and high myopia (≥ − 6.00 D)
[9]. All the patients provided informed consent. The study Corneal wavefront aberration measurement
followed the tenets of the Declaration of Helsinki and Corneal wavefront aberration were measured by a rotat-
institutional review board. ing Scheimpflug Camera (Pentacam; Oculus). The exam-
inations were made in a dark room in the morning.
Patient enrolment criteria Higher order aberrations (HOAs) of the cornea with a
Inclusion criteria were as follows: age over 18 years with 6.0-mm analysis diameter were calculated separately
stable refraction for at least 12 months, corrected dis- from the total cornea preoperatively and 6 months
tance visual acuity (CDVA) of at least 20/25, cylinder re- postoperatively.
fraction lower than 2.0 diopter (D), discontinued contact
lens use for at least 1 month, free of ocular disease and Statistical analysis
estimated postoperative corneal stromal bed thickness of Data were analyzed using SPSS 20.0 (SPSS Inc., Chicago,
more than 350 μm. IL, USA). The one-way analysis of variance (ANOVA)
was used to compare the differences between the study
Preoperative examination groups. LSD was performed in the analysis. Differences
Preoperative examination included slit-lamp examin- with a p value of 0.05 or less were considered statistically
ation, intraocular pressure measurement, corneal epithe- significant. Pearson correlation test was used to analyze
lium assessment by fluorescein staining, tear breakup the correlation between the attempted SE refraction and
time, Schirmer I test, UDVA and CDVA, corneal topog- the achieved SE refraction.
raphy (Optikon SpA, Rome, ITALY), pentacam scheimp-
flug topography (Oculus, Wetzlar, Germany), manifest Results
and cycloplegic refraction, ultrasound pachymetry and A total of 96 eyes were included in this study. Each
fundus examination. group included 32 eyes. All eyes completed the
six-month follow-up. The patients’ characteristics were
Surgical technique shown in Table 1.
All surgeries were performed by a single surgeon using
the SCHWIND Amaris 500E excimer laser platform Visual acuity
(SCHWIND eye-tech-solutions GmbH, Kleinostheim, Table 2 shows the preoperative variables of patients. The
Germany). The ablation algorithm was calculated logMAR CDVA was not significantly different between

Table 1 Demographic characteristics of study patients


Group Patients/eyes Gender Mean age Age range
Low myopia 21/32 16 women, 5 men 30.76 ± 5.17 20–37
Moderate myopia 18/32 15 women, 3 men 29.11 ± 5.17 19–37
High myopia 21/32 11 women, 10 men 30.57 ± 4.43 23–38
Age is expressed as mean years±SD; Low myopia vs Moderate myopia P = 0.301; Low myopia vs High myopia P = 0.901; Moderate myopia vs High
myopia P = 0.360
Xi et al. BMC Ophthalmology (2018) 18:209 Page 3 of 8

Table 2 Preoperative Variables of Patients


Low myopia Moderate myopia High myopia
(Mean ± SD) (Mean ± SD) (Mean ± SD) F (P) P
*<0.001

Sphere (D) −1.25 to −3.00 −3.25 to −5.50 −6.00 to −7.50 349.29 (<0.001) <0.001

−2.43 ± 0.57 −4.16 ± 0.72 −6.39 ± 0.50 <0.001
*0.296

Cylinder (D) 0.00 to −1.75 0.00 to − 1.75 0.00 to − 1.75 2.332 (0.103) 0.27

−0.70 ± 0.46 −0.56 ± 0.54 − 0.88 ± 0.58 0.033
*0.02

SE refraction (D) −1.25 to −3.625 −3.25 to −6.25 −6.00 to −8.00 262.51 (<0.001) <0.001

−2.78 ± 0.65 −4.43 ± 0.85 −6.85 ± 0.61 <0.001
*<0.001

UDVA (logMAR) 0.30 to 1.30 0.70 to 1.50 0.80 to 1.50 32.22 (<0.001) <0.001

0.77 ± 0.21 0.97 ± 0.19 1.18 ± 0.20 <0.001
*0.002

CDVA (logMAR) 0.00 to −0.20 0.00 to −0.20 0.00 to −0.20 5.01 (<0.001) 0.198

−0.128 ± 0.063 −0.075 ± 0.072 − 0.103 ± 0.07 0.067
SE = spherical equivalent refraction, UCVA = uncorrected visual acuity, CDVA = corrected distance visual acuity
Data are expressed as means±SD. *Low myopia vs Moderate myopia. †Low myopia vs High myopia. ‡Moderate myopia vs High myopia

the high myopia group and the low group (P = 0.198), between the high myopia group and the moderate myopia
and between the high group and the moderate group group (P = 0.636). The postoperative UDVA was lower in
(P = 0.067). After six months, 100% of low myopia the high myopia group than in low to moderate myopia
and moderate myopia had a UDVA of logMAR (20/20) or groups (P < 0.001; P = 0.002). The postoperative SE was
better, 94% of high myopia eyes had a UDVA of logMAR shown in Fig. 3. 65.7% of eyes had SE within ±0.50D in
(20/20) or better (Fig. 1). There was no significant differ- the high myopia group, 78.1% and 87.5% in the low and
ence between the high myopia group and the moderate moderate myopia groups. After 6 months, 90.6% of eyes
myopia group in the CDVA (P = 0.057) (Table 3). The best had between 0.00 and 0.50D of astigmatism in the low
corrected visual acuity of patients with low myopia, mod- myopia group, as compared with 87.5% in the moderate
erate myopia and high myopia is greater than logMAR group and 71.9% in the high myopia group (Fig. 4).
(20/20). Figure 2 shows the change of Snellen lines of log- The correlation between attempted and achieved SE
MAR CDVA. No eye lost 2 or more lines of CDVA. datas were shown in Fig. 5 (R2 = 0.81 for low myopia, R2 =
0.80 for moderate myopia and R2 = 0.67 for high myopia).
Refractive results and accuracy 4% of the eyes were overcorrected in the low myopia and
Table 3 shows the postoperative refraction. The spherical the high myopia group. 16% of the eyes were overcorrected
equivalent refraction (SE) was not significantly different in the moderate myopia group.

Fig. 1 Cumulative percentage of eyes achieving uncorrected distance visual acuity (UDVA) 6 months postoperatively. (a mild; b moderate; c high)
Xi et al. BMC Ophthalmology (2018) 18:209 Page 4 of 8

Table 3 Postoperative Variables of Patients


Low myopia Moderate myopia High myopia
(Mean ± SD) (Mean ± SD) (Mean ± SD) F (P) P
*<0.001

Sphere (D) 0.00 to − 0.75 −0.75 to 1.25 − 0.50 to 1.00 12.10 (<0.001) <0.001

−0.32 ± 0.23 0.19 ± 0.54 0.28 ± 0.51 0.406
*0.705

Cylinder (D) 0.00 to −0.75 0.00 to −1.00 0.00 to −1.00 0.98 (0.378) 0.079

−0.32 ± 0.23 −0.34 ± 0.23 − 0.43 ± 0.27 0.196
*0.015

SE refraction (D) −0.25 to 1.125 −0.875 to 1.00 −1.00 to 0.875 3.45 (0.036) 0.048

0.30 ± 0.33 0.02 ± 0.51 0.07 ± 0.52 0.636
*0.408

UDVA (logMAR) −0.20 to 0.00 −0.20 to 0.00 −0.20 to 0.10 8.65 (<0.001) <0.001

−0.106 ± 0.05 −0.09 ± 0.05 − 0.047 ± 0.076 0.002
*0.18

CDVA (logMAR) −0.20 to 0.00 −0.20 to 0.00 − 0.20 to 0.00 5.43 (0.006) 0.001

−0.159 ± 0.056 −0.138 ± 0.066 − 0.106 ± 0.072 0.057
SE = spherical equivalent refraction, UCVA = uncorrected visual acuity, CDVA = corrected distance visual acuity.Data are expressed as Means±SD. *Low myopia vs
Moderate myopia. †Low myopia vs High myopia. ‡Moderate myopia vs High myopia

Safety and efficacy Table 4 showed that the high myopic corneal HOAs
The mean safety index was over 1.0 in the three groups (1.07 ± 0.26) were significantly higher than low myopic
(Fig. 6). The safety index was not significantly different corneal HOAs (0.64 ± 0.20) (P<0.001) and moderate my-
between the high myopia group (1.01 ± 0.14) and the opic corneal HOAs (0.75 ± 0.20) (P < 0.001).
low myopia group (1.08 ± 0.15) (P > 0.05). The moderate
myopia group (1.16 ± 0.23) was significantly higher than Discussion
the high myopia group (P = 0.002). This study demonstrated that one-step TransPRK could
The efficacy index was 0.96 ± 0.16 in the low myopia correct low to high myopia effectively. Six months after
group, 1.05 ± 0.20 in the moderate myopia group, and surgery, there was a significant improvement in UDVA,
0.89 ± 0.17 in the high myopia group. The differences in SE and astigmatism in the low, moderate and high my-
efficacy index between the high myopia group and the opia groups. More than 95% of the treated eyes were
low myopia were not statistically significant (P = 0.14). within ±1.00D of the intended target refraction. No eye
However, the moderate myopia group was significantly lost two or more lines of CDVA.
higher than high myopia group (P = 0.002). Nearly 80% of the eyes in the low and moderate myopia
groups and 65% of eyes in the high myopia group reached
Corneal HOAs within ±0.50D of SE by six months after the operation.
The preoperative Corneal HOAs were not significantly Previous clinical studies [3, 4, 10–13] have reported ac-
different between the three groups. After six months, ceptable visual and refractive outcomes after TransPRK.

Fig. 2 Changes in corrected distance visual acuity (CDVA) 6 months after TransPRK. (a mild; b moderate; c high)
Xi et al. BMC Ophthalmology (2018) 18:209 Page 5 of 8

Fig. 3 Percentage of eyes achieving various ranges of SE 6 months after TransPRK. (a mild; b moderate; c high)

However, most of these studies concentrated on low and no significant differences in the SE within ±1.0D. We
moderate myopia or high myopia only. In this study, we found a difference between the attempted and the
analyzed our results in different groups of myopia. achieved SE correction in the three groups, with a ten-
In our study, 100% of low and moderate myopia dency of overcorrection. The overcorrection may be re-
eyes achieved a UDVA of 20/20 or better six months lated to corneal dehydration during surgery. The longer
after the operation, while 94% of the high myopia time possibly increases dehydration of the corneal
eyes achieved a UDVA of 20/20 or better. Our results stroma [1]. We suppose that the ablation of TransPRK
are comparable to the previous studies of TransPRK should be modified in our future work.
[3, 5, 7] and small-incision lenticule extraction. [14, In terms of safety, the mean safety index was greater
15] We found a statistically significant difference in than 1.0 in the three groups. The highest safety index
postoperative UDVA between the low and moderate was seen in the moderate myopia group in our study. In
myopia groups versus the high myopia group. The the low myopia group, 93.8% of eyes had no change or
reason may be the increased HOAs of the cornea better CDVA postoperatively. In the moderate myopia
postoperatively or the changes of high myopia fundus group, 15.6% of eyes lost one line of CDVA and more
preoperatively. However, there was no significant dif- than a half of eyes gained one or two lines of CDVA
ference in the CDVA between the moderate myopia postoperatively. While in high myopia group, 22% of
group and the high myopia group. This indicated that eyes lost one line CDVA. However, no statistically sig-
TransPRK for high myopia was safe. nificant difference was found in the postoperative CDVA
In our high myopia group, 65.7% of eyes were within between the moderate and high myopia groups. The loss
±0.50D and 100% of eyes were within ±1.0D of the of the BCVA may be caused by the increase of the
intended SE refraction six months postoperatively. Our HOAs on the cornea postoperatively. Our results are
results agreed to some extent with other studies. Anto- more or less similar to other studies of refractive surger-
nios et al. [3] found that 81.3% and 96.6% were within ies. Antonios R et al. [3] reported that 81.3% of high my-
±0.50D and ± 1.0D in high myopia patients 12 months opia eyes were between±0.50D after the treatment of
postoperatively. Aslanides et al. [13] reported 91.4% and TransPRK. Serrao S et al. [16] reported the safety index
97.1% were within ±0.50D and ± 1.0D by using Mitomy- of the high myopia eyes treated by PRK was 0.81 one
cin C (MMC) therapy for the prevention of haze. They year postoperatively. Ikeda T et al. [17] found 77% of
got accurate results than us within ±0.50D. There were high myopic eyes showed no change or gain in CDVA

Fig. 4 Percentage of eyes achieving various ranges of astigmatism 6 months after TransPRK. (a mild; b moderate; c high)
Xi et al. BMC Ophthalmology (2018) 18:209 Page 6 of 8

Fig. 5 Achieved versus attempted spherical equivalent corrections 6 months postoperatively (a mild; b moderate; c high)The black line indicates
the outcome of linear regression analysis, the area between two blue lines mean within ±0.50D

one year after LASIK. Torky MA et al. [14] found that more influenced by the difference between the surgical
88.2% of high myopic eyes got the SE within±0.50D by setting of corneal thickness and actual corneal thickness.
SMILE surgery six months postoperatively. Similarly, Jin Corneal HOA changes were evaluated in this study.
HY et al. [18] found that 87% of high myopic eyes got We found a significant increase in total corneal HOAs
the SE within±0.50D by SMILE surgery . after surgery. Previous studies had reported that HOAs
Moreover, the efficacy and UDVA were improved sig- were related to the shadows, halos and night vision glare
nificantly in each group. The highest efficacy index was [19, 20]. The high myopia group showed significantly
seen in the moderate myopia group. No differences in higher corneal HOAs than the low and moderate my-
efficacy were found between the high myopia group and opia groups. One study found that an RMS value of
the low myopia group. The study indicates that HOAs less than 1.0 had no noticeable effect on the clar-
TransPRK is effective for moderate myopia, as well as ity of retinal image, while blur could be seen with 1.0 to
mild and high myopia. The single-step ablation profile 1.5 μm of wavefront aberrations [21]. This may cause
targets 55 μm centrally and 65 μm peripherally, using the decreased CDVA and UDVA in high myopia group
theoretical simulations for the scope of ablation optical postoperatively.
zone (OZ). Different patients showed different corneal In conclusion, our data shows that TransPRK is a safe
epithelial thicknesses. Mild myopia patients may be and effective surgical option in mild to high myopia. A

Fig. 6 a Safety index (ratio of postoperative CDVA/preoperative CDVA). b Efficacy index (ratio of postoperative UDVA/preoperative CDVA)
Xi et al. BMC Ophthalmology (2018) 18:209 Page 7 of 8

Table 4 Summary of corneal HOAs preoperatively and six months postoperatively


Preoperation F (P) P Postoperation F (P) P
Low myopia 0.39 ± 0.11 2.18 (0.119) *0.808 0.64 ± 0.20 33.21 (<0.001) *0.058
† †
Moderate myopia 0.40 ± 0.12 0.058 0.75 ± 0.20 <0.001
‡ ‡
High myopia 0.45 ± 0.14 0.098 1.07 ± 0.26 <0.001
Data are expressed as Means±SD. *Low myopia vs Moderate myopia. †Low myopia vs High myopia. ‡Moderate myopia vs High myopia

large sample size and long-term results are needed in Received: 12 December 2017 Accepted: 17 August 2018
furture studies.
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