Effect of Overnight Orthokeratology Lens Wear on Sleep and Quality of Life in Children Aged 8-12 Years and Relationship Between Corneal Morphology and Visual Function

doi:10.21203/rs.3.rs-2453761/v1

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Effect of Overnight Orthokeratology Lens Wear on Sleep and Quality of Life in Children Aged 8-12 Years and Relationship Between Corneal Morphology and Visual Function

https://doi.org/10.21203/rs.3.rs-2453761/v1

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It was to investigate vision, sleep, quality of life (QOL), and corneal morphology changes before and after overnight orthokeratology lens wear in myopic children aged 8–12 years. 100 myopic children were randomly divided into control group and test group, and glasses and overnight orthokeratology lens wear were worn separately. Uncorrected visual acuity, refraction, axial length, corneal endothelial cells, and corneal morphology were compared beforewear (0d), and 1 month (1mo), 3 months (3mo), and 6 months (6mo) after wear. The OQASTM II was used to evaluate visual quality, the Pittsburgh sleep quality index (PSQI) was used to evaluate sleep quality, and the QOL scale was used. Compared with 0d, there were significant differences in uncorrected visual acuity, refraction, axial length, corneal cell morphology, corneal morphology, visual quality, PSQI score, and QOL score between the control group and the test group (P < 0.05). Compared with the control group, in the test group, the uncorrected visual acuity, refraction, corneal cell variation coefficient, and QOL score at 3mo and 6mo after wear increased (P < 0.05); axial length, corneal endothelial cell density, hexagonal cell ratio, sleep onset time, sleep disorders, daytime function, PSQI, and OQAS values decreased (P < 0.05); subjective sleep quality, sleep duration, and sleep aids increased at 1mo after wear (P < 0.05). Myopic children with overnight orthokeratology lens wear can improve vision, life and sleep quality, but subjective sleep quality is reduced at early wear.

orthokeratology

glass

visual quality

sleep quality

quality of life (QOL)

Myopia is a very common refractive error disease, and myopia in China has emerged younger age and high incidence characteristics [1]. Because the human eye is a multi-structured optical system, correction of myopia requires consideration of the cornea, lens, eye axis length, and other major refractive factors. Poor myopia control develops into high myopia or pathological myopia, and complications such as retinal detachment, macular hole, and cataract occur [2]. Correction of myopia is divided into surgical treatment and non-surgical treatment. Surgical treatment is divided into excimer laser keratectomy and lens implantation, while non-surgical treatment includes spectacle wearing and orthokeratology [3]. Although wearing glasses can improve the patient’s vision, it does not prevent the process of myopia. Orthokeratology is a method to temporarily eliminate or change refractive errors by wearing specially designed rigid contact lenses for the remodeling of corneal morphology, which is often used in the treatment of ocular diseases such as myopia, hyperopia, astigmatism, and presbyopia [4, 5]. With the development of orthokeratology lens, overnight orthokeratology lens wear is to improve the uncorrected visual acuity of patients by wearing special rigid contact lenses at night and is suitable for patients with low or moderate myopia [6]. Overnight orthokeratology lens wear allows patients to achieve excellent uncorrected vision during the day by wearing it for only 7 to 8 hours during sleep.

Overnight orthokeratology lens wear at the initial stage, the patient’s daytime corneal morphology and refraction will undergo regression problems, and when the expected degree of correction is achieved, the change in refraction will also reach a stable state [7]. Some scholars have pointed out that orthokeratology lens can affect the visual quality because of factors such as irregular corneal astigmatism and higher order corneal aberrations while correcting myopia [8]. At present, most studies mainly focus on the effect of orthokeratology lens on the visual acuity and contrast sensitivity of children before and after wearing, and there are relatively few studies on the visual quality. The indicators used to evaluate the correction effect of orthokeratology lens include refraction, uncorrected visual acuity, keratometry, corneal thickness, and contrast sensitivity.The OQASTM II is a novel device for the evaluation of visual quality in the human eye, which enables the evaluation of visual quality through an optical two-channel system and using imaging analysis of point light sources on the retina [9]. No matter what form of contact lens wear is used, it will affect the corneal morphology and physiological status of patients to some extent. It has been confirmed that long-term contact lens wear can cause eye diseases such as conjunctivitis in patients [10, 11]. Therefore, while using orthokeratology lens to improve visual acuity, it is also necessary to pay attention to the normal physiological status and function of cornea by external factors. In addition to exploring the effect of orthokeratology on visual acuity, studies on the quality of life (QOL) of postoperative patients also need to be focused on. However, whether long-term overnight orthokeratology lens wear affects the normal physiological and metabolic activities of the cornea and corneal function in children is unknown. Overnight orthokeratology lens wear is worn during sleep, and whether it affects the patient’s nocturnal sleep quality and QOL also need to be explored.

The effects of wearing glasses and overnight orthokeratology lens wear on corneal morphology, visual quality, sleep quality, and QOL in children with myopia were compared to provide a reference for the clinical application of overnight orthokeratology lens wear.

Study subjects

100 myopic children who visited Guangxi Hospital from May 2019 to May 2021 were selected as the study subjects and randomly divided into test group and control group, 50 cases for each group, and 100 eyes for each group. Inclusion criteria: (1) Children meeting the clinical diagnostic criteria of myopia in adolescents; (2) Children aged 8 ~ 12 years old; (3) Children without other eye diseases except refractive error; (4) Children without eye surgery, trauma history, and wearing contact lenses; (5) Children without keratitis, glaucoma, acute conjunctivitis, dry eye, and other contraindications to wearing contact lenses; (6) Children with successful follow-up and good compliance, according to the doctor’s advice to complete the correction. Exclusion criteria: (1) Children with previous history of ocular surgery; (2) Children with amblyopia or strabismus; (3) Children with abnormal corneal endothelial cells; (4) Children combined with family history of keratoconus; (5) Children’s sleep quality was affected due to anxiety, depression, academic stress, drugs, and other factors; (6) Children who failed to complete the treatment. It was approved by ethics committee of Guangxi Hospital. The children’s legal guardian signed an informed consent.

Treatment Method

Control group: children were treated with spectacles. Spectacles were made according to each child’s refraction and worn. Test group: overnight orthokeratology lens wear. Orthokeratology lens was provided by OVCTEK Inc., the material was Bostom XO, the oxygen permeability coefficient was 100 × 10^− 11 (cm²·mLO₂)/(s·mL·mmHg), the diameter was 10.5 ~ 11.0 mm, the central thickness of optical zone was 0.22 mm, and the inner surface was anti-geometric four-arc design. The slit-lamp microscope was used to determine the ocular condition of the children, and the children who meet the treatment requirements would have a trial match of the diagnostic lens. The professional personnel determined the E value of corneal topography and K value of corneal curvature flat of the child, and then selected the wearing lens. Following fluorescein staining, lenses were evaluated for lens condition and adjusted using a slit-lamp microscope under cobalt blue light. Finally, it was required that the lens should have good center positioning, and 3.0 ~ 4.0 mm in the middle of lens was flat area, 1.0 ~ 2.0 mm fluorescence filling area at the reverse arc, the positioning arc could be in parallel contact with cornea, 1.0 ~ 2.0 mm fluorescence filling area at around, and the lens had the range of motion of 0.5 ~ 1.0 mm. After meeting the above ideal requirements, the lenses were customized. Children in the test group were asked to wear orthokeratology lens at night for 7 to 8 hours. The indexes of the two groups were evaluated before treatment (0d), and 1 month (1mo), 3 months (3mo), and 6 months (6mo) after treatment.

Outcome Measures

Outcome measures

(1) Uncorrected visual acuity, refraction, and axial length: The uncorrected visual acuity of the children was evaluated using the international standard logarithmic visual acuity test table. Ocular refraction was measured using an autorefractor. Axial length was measured using an optical biometer.

(2) Corneal endothelial cells: The central corneal endothelial cell density (CECD), cell variation coefficient (CVC), and proportion of hexagonal cells were evaluated by SP-300P corneal endothelial cell counter. The patient lay supine on the examination table, and the software interface in the examination instrument was logged in, and the patient information was selected; then the photography window was opened, the direction adjustment icon in the software interface was clicked using the mouse to observe and focus the dynamic image of the eye window of the patient; a photograph was taken after adjusting to the optimal state; CECD and hexagonal cell counting were performed through the photographed image.

(3) Corneal morphology: The central corneal thickness was measured by ultrasonic corneal measuring instrument. The patient lay supine on the examination table.Topical anesthetic eyedrops were instilled into the examined eye of the patient and the eyes were closed for several minutes; 75% alcohol was used to disinfect the ultrasound probe, and the patient opened eyes and gazed at a fixed position above, and then the probe was gradually entered into the examined eye; when the probe contacted the corneal surface, it was vertically touching the corneal surface; repeated measurements at the same point were carried out for many times and the mean value was taken.

(4) Visual quality: The OQASTM II visual quality analysis system was used to evaluate the visual quality of the children. Parameters evaluated included objective scattering index (OSI), modulation transfer function cutoff (MTF_cutoff), 100% OQAS value (OV100%), 20% OQAS value (OV20%), and 9% OQAS value (OV9%).

(5) Sleep quality: Pittsburgh sleep quality index (PSQI) [12] was used to evaluate the sleep quality of children. The PSQI is able to categorize sleep duration and quality and contains 19 self-rated and 5 other-rated items. However, the 18 self-rated items involved in scoring are mainly divided into 7 factors: subjective sleep quality, sleep onset time, sleep duration, sleep disorders, sleep aids, and daytime function, and each factor is scored according to grade 4. The total PSQI score is 21, and the higher the score, the worse the sleep quality of the children. It is considered that when the PSQI score is less than 4 points, it is excellent sleep quality; when the score is 4 ~ 8 points, it is fair sleep quality; when the score is more than 8 points, it is poor sleep quality.

(6) QOL: QOL scale [13] was used to evaluate the QOL of the children. The QOL scale includes 8 dimensions of physical functioning (PF), role physical (RP), bodily pain (BP), general health (CH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH), each with 100 points. Higher scores on the QOL scale indicate better QOL.

Statistical analysis

Statistical analysis was performed using SPSS 19.0 software. Enumeration data were expressed as n (%) and χ² test was performed. Measurement data were expressed as (\(\overline{\text{x}}\)±s), and independent sample t test was performed. P < 0.05 was considered statistically significant.

The differences between the general data of the control group and the test group were compared. It was found that there was no significant difference in mean age, sex ratio, spherical refraction, cylindrical refraction, intraocular pressure, and course of disease between the control group and the test group (P > 0.05) (Table 1).

Table 1

Comparison of basic data between the two groups.
Group	Age (years old)	Male (n/%)	Spherical refraction (D)	Cylindrical refraction (D)	Intraocular pressure (mmHg)	Course of disease (years)
Control group (n = 50)	10.52 ± 1.66	31/62	-2.32 ± 0.89	-0.42 ± 0.06	16.33 ± 2.15	2.35 ± 0.47
Test group (n = 50)	10.37 ± 1.53	33/66	-2.41 ± 0.93	-0.45 ± 0.11	16.47 ± 2.80	2.40 ± 0.31
Statistic value	-0.152	0.229	0.310	0.251	0.104	-0.058
P	0.784	0.803	0.911	0.740	0.659	0.743

The changes of uncorrected visual acuity, refraction, and axial length were compared between the control group and the test group. It was found that with the prolongation of treatment time, the uncorrected visual acuity, refraction, and axial length of patients in both groups showed a gradually increasing trend, and the uncorrected visual acuity and refraction level of patients in the test group increased faster than those in the control group.Compared with at 0d, the uncorrected visual acuity, refraction, and axial length of the control group and test group were significantly increased at 1mo, 3mo, and 6mo (P < 0.05). Compared with the control group, the uncorrected visual acuity and refraction were significantly increased, while the axial length was significantly decreased of test group at 1mo, 3mo, and 6mo (P < 0.05) (Fig. 1).

Comparing the difference of corneal endothelial cell indexes CECD, CVC, and proportion of hexagonal cells between the control group and the test group, it was found that with the extension of treatment time, the CECD and proportion of hexagonal cells in the control group and the test group gradually decreased, while CVC gradually increased. Similarly, the change trend of each indicator in the test group was greater than that in the control group.Compared with at 0d, the proportion of CECD and hexagonal cells in the test group was significantly decreased, and CVC was significantly increased at 1mo, 3mo, and 6mo (P < 0.05). Compared with at 0d, the proportion of hexagonal cells in the control group was significantly decreased, and CVC was significantly increased at 1mo, 3mo, and 6mo (P < 0.05). CECD was significantly lower in the control group at 6mo compared with at 0d (P < 0.05). Compared with the control group, CECD was significantly decreased at 6mo (P < 0.05), hexagonal cells were significantly decreased at 1mo, 3mo, and 6mo (P < 0.05), and CVC was significantly increased at 1mo, 3mo, and 6mo in test group (P < 0.05) (Fig. 2).

The difference of central corneal thickness between the control group and the test group was further analyzed, and it was found that with the increase of treatment time, the central corneal thickness of the control group slightly decreased, while that of the test group slightly increased.There was no significant difference in central corneal thickness between the control group and the test group at different time points before and after treatment (P > 0.05) (Fig. 3).

The changes of visual quality in the control group and the test group were detected and compared by OQASTM II system. It was found that the visual quality evaluation parameters OSI, MTF _cutoff, OV100%, OV20%, and OV9% in the control group and the test group had different degrees of changes, while the changes of each parameter in the test group tended to be relatively large.Compared with 0d, OSI increased, and MTF _cutoff, OV100%, and OV20% decreased significantly at 1mo, 3mo, and 6mo (P < 0.05), OV9% increased significantly (P < 0.05) at 1mo, and OV9% decreased significantly (P < 0.05) at 3mo and 6mo in the control and test groups. Compared with the control group, OSI increased, MTF _cutoff, OV100%, and OV20% decreased significantly at 1mo, 3mo, and 6mo (P < 0.05), OV9% increased significantly at 1mo (P < 0.05), and OV9% decreased significantly at 3mo and 6mo (P < 0.05) in the test group (Fig. 4).

The PSQI scale was used to evaluate the changes of sleep quality in the control group and the test group. The scale was divided into subjective sleep quality, sleep onset time, sleep duration, sleep disorders, sleep aids, daytime function, and PSQI total score indicators. In the test group, the changes of each evaluation indicator at 1mo after treatment were greater, but the scores at 3mo and 6mo after treatment were reduced to varying degrees. It was also found that the sleep aids scores of children in the control group were always 0 at different treatment times. Compared with at 0d, the subjective sleep quality, sleep duration, and PSQI score of the test group were significantly increased at 1mo (P < 0.05), and the sleep onset time, sleep duration, sleep disturbance, daytime function, and PSQI score of the test group were significantly decreased at 3mo and 6mo (P < 0.05). Compared with the control group, the subjective sleep quality was significantly increased at 1mo, 3mo, and 6mo (P < 0.05), and the sleep onset time, sleep disturbance and daytime function were significantly decreased at 3mo and 6mo in the test group (P < 0.05). However, there was no significant difference in sleep time and PSQI score between the control group and the test group at 3mo and 6mo after treatment (P > 0.05) (Fig. 5).

In order to further evaluate the effect of different treatments on the quality of life of children with myopia, SF-36 scale was used to evaluate. It was found that with the increase of treatment time, the scores of all dimensions of SF-36 scale in the control group and the test group showed an increasing trend to different extents, with the changes in the test group being more obvious.Compared with at 0d, PF, RP, BP, CH, VT, SF, RE, and MH scores were significantly higher in the control group and test group at 1mo, 3mo, and 6mo (P < 0.05). Compared with the control group, the PF, RP, BP, CH, VT, SF, RE, and MH scores of patients in the test group were significantly higher at 1mo, 3mo, and 6mo (P < 0.05) (Fig. 6).

Myopia has gradually become a public health concern all over the world, and the factors affecting the process of myopia are also the focus of epidemiological research. Both retinal circadian clock and circadian rhythm are involved in regulating the refractive development of the eyeball, and disturbances in sleep rhythm may induce myopia [14, 15]. The wearing of spectacles is a commonly used correction method for myopic children, which can effectively adjust the refraction, but the long-term correction effect is not good [16]. Studies have confirmed that some myopic patients also experience problems with reduced visual acuity after wearing glasses, which affects the QOL of patients [17, 18]. Orthokeratology lens can adjust the overall shape of cornea through mechanical compression of eyelids, lens reconstruction, lens surface tension, and tear hydraulic suction, and then rapidly improve the uncorrected visual acuity of patients [19]. For this reason, wearing orthokeratology lens can flatten and thicken the central corneal region in myopic patients, followed by short-term reduction of refraction, and long-term wear can control the progression of myopia. In this experiment, uncorrected visual acuity and refraction were higher, while axial length was reduced 1 to 6 months after overnight orthokeratology lens wear treatment than in children treated with spectacles. When overnight orthokeratology lens wear is used to correct visual acuity, the main reason for its success depends on the equivalent refraction, while the change of equivalent refraction is determined by the change of curvature [20]. In this experiment, the uncorrected visual acuity and refraction of children 1 ~ 6 months after overnight orthokeratology lens wear treatment showed a gradually improving trend, which was in line with the characteristics of continuous fluctuation of keratometry.Therefore, overnight orthokeratology lens wear can improve uncorrected visual acuity and refraction, and reduce axial length in the treatment of myopic children, which is conducive to the recovery of children.

Orthokeratology, as a non-surgical method, can correct refractive errors and improve uncorrected visual acuity and higher order aberrations in patients [21]. Overnight orthokeratology lens wear can conveniently, quickly, and effectively maintain the patients’ daytime visual status, while long-term wear needs to consider its effect on the child’s corneal morphology [22]. Corneal endothelial cells as well as corneal thickness are important indicators to assess the effect of orthokeratology lens on corneal health [23]. In this experiment, CECD and hexagonal cell proportion decreased, while CVC increased 1 to 6 months after overnight orthokeratology lens wear treatment, showing that long-term overnight orthokeratology lens wear caused slight changes in corneal endothelial cell morphology in children, but the effect was small. Corneal thickness is an indirect measure of corneal endothelial cell function [24]. Central corneal thickness did not change significantly 1 to 6 months after overnight orthokeratology lens wear treatment. For this reason, the effect of long-term overnight orthokeratology lens wear on corneal thickness needs in-depth study. OQASTM II visual quality system evaluation parameters showed that MTF _cutoff, OV100%, OV20%, and OV9% parameters were decreased, while OSI was increased after long-term overnight orthokeratology lens wear. It showed that the visual quality of children showed a trend of first decrease and then increase after overnight orthokeratology lens wear. Children with myopia after overnight orthokeratology lens wear treatment developed problems with decreased visual quality, which may be due to affecting the cleanliness of the lens or lens deviation problems during wear. Keratitis caused by orthokeratology lenses and tear changes may cause a decrease in the quality of vision in children. Therefore, in the future clinical treatment application, it is necessary to strengthen the comfort after wearing orthokeratology lens, standardize the patient’s wearing operation, and instruct the patient to pay attention to hygiene during wearing, as well as the fitting state of orthokeratology lens, so as to improve the visual quality.

There is a significant relationship between sleep quality and the prevalence of myopia [25]. The incidence of sleep disorders in myopic patients is significantly increased, and it mainly shows problems such as worse subjective sleep quality and insufficient sleep duration [26, 27]. Because overnight orthokeratology lens wear is worn during nocturnal sleep, its effect on the sleep quality of children was explored. Subjective sleep quality, sleep onset time, sleep duration, and PSQI scores increased 1 month after overnight orthokeratology lens wear, while sleep onset time, sleep disturbance, and daytime function scores decreased 3 to 6 months after wear. It was found that children who wore spectacles during treatment always scored 0 on sleep aids because wearing spectacles did not affect their sleep patterns at night. Children wearing orthokeratology lenses will increase the probability of sleep disorders due to maladjustment and anxiety, tension, and other adverse emotions, for this reason, it is necessary to use drugs to help sleep, in order to improve the sleep quality of children and further ensure the mental status of the next day and normal life and learning.This is because when wearing overnight orthokeratology lens at the beginning, children will have anxiety and tension due to concerns about lens detachment and eye damage, which in turn affects the quality of sleep [28]. The overnight orthokeratology lens wear can affect the stability of the tear film, shorten the tear film break-up time, and produce foreign body sensation and burning sensation, which in turn affects the quality of sleep [29]. With the improvement of overnight orthokeratology lens wear comfort and the construction of treatment confidence, the child’s anxiety and other adverse emotions gradually disappeared, for which the subjective sleep quality was gradually improved [30]. Subsequently, QOL scale was used to evaluate the QOL of the children, and the results showed that the PF, RP, BP, CH, VT, SF, RE, and MH scores were significantly increased after overnight orthokeratology lens wear for 1 to 6 months, and were higher than those of the children wearing the glass, indicating that orthokeratology overnight lens wear could improve QOL.

In order to investigate the effect of overnight orthokeratology lens wear on sleep quality and quality of life in myopic children aged 8–12 years, the effect of overnight orthokeratology lens wear treatment on visual quality, sleep quality, and QOL in myopic children was analyzed using children wearing spectacles as controls. It was found, overnight orthokeratology lens wear can improve the uncorrected visual acuity and refraction of children with myopia, and can also adjust the visual quality of children. Overnight orthokeratology lens wear can affect the subjective sleep quality of children at the early stage, but with the extension of wearing time, the sleep quality and QOL of children were significantly improved. Because the sample size is small and the children are young, the safety of overnight orthokeratology lens wear on the health status of corneal endothelial cells and long-term wear in children needs to be explored in depth. Only comparing the treatment differences between spectacles and overnight orthokeratology lens wear, the treatment effect of daily orthokeratology lens wear was not considered. In future studies, it is also necessary to further consider the effect of different wearing time on the visual acuity, sleep quality, and QOL of myopic children.In conclusion, this experiment can improve the therapeutic effect of myopic children and lay a foundation for the clinical application of overnight orthokeratology lens wear.

Ethical Approval

This study was approved by Ethics Committee of Guangxi Hospital. Written informed consent was obtained from individual in the study.

Conflicts of Interest

No conflict of interest exits in the submission of this manuscript, and manuscript is approved by all authors for publication.

Authors' contributions

Dr. Lu Yaiyan managed the project. Dr. Hong Huali, Dr. Long Yijiao, Dr. Li Lihong, and Dr. Lin Weien performed the research of the project.

Funding

It was done at personal expense.

Availability of data and materials

The data used to support the findings of this study are included within the article.

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Effect of Overnight Orthokeratology Lens Wear on Sleep and Quality of Life in Children Aged 8-12 Years and Relationship Between Corneal Morphology and Visual Function

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