A randomized trial of rigid gas permeable contact lenses to reduce progression of children’s myopia

doi:10.1016/S0002-9394(03)00106-5

American Journal of Ophthalmology

Volume 136, Issue 1, July 2003, Pages 82-90

https://doi.org/10.1016/S0002-9394(03)00106-5 Get rights and content

Abstract

Purpose

To test whether rigid gas permeable (RGP) contact lens wear can reduced the rate of myopia progression in school age children.

Design

Randomized clinical trial.

Methods

Setting: Single clinical center.

Study Population: Both eyes of 428 Singaporean children.

Inclusion Criteria: 6 through 12 years of age with myopia between −1 and −4 diopters, astigmatism ≤ 2 diopters, no prior contact lens wear, no other ocular pathologies.Intervention: Spectacle or RGP lens correction for myopia. After a 3-month adaptation period, 383 children were followed, and 298 (78%) remained after 24 months.Outcome measures: Cycloplegic subjective refraction, keratometry, and axial length measured at 12 and 24 months.

Results

Children who adapted to contact lenses wore them for a median of 7 hours per day, but no more than 40% wore them at least 8 hours per day, 7 days per week. Spectacles were worn for a median of 15 hours per day at the time of the 24-month follow-up. There was an increase in the spherical equivalent of −1.33 and −1.28 diopters (P = .64), and axial length increased by 0.84 and 0.79 mm (P = .38) over 2 years among children randomized to contact lenses and spectacles, respectively. Adjustment for baseline differences between the groups and for hours per day of contact lens wear did not alter these findings.

Conclusions

Rigid gas permeable lenses did not slow the rate of myopia progression, even among children who used them regularly and consistently. It is unlikely that this intervention holds promise as a method by which to slow the rate of progression of myopia in children.

Section snippets

Design

The study was a clinical trial, where children were randomized to use either rigid gas permeable contact lenses or spectacle correction for treatment of myopia. Patients were randomized prior to adaptation to contact lens wear.

Setting

Children were enrolled and all examinations were conducted at the Myopia Clinic of the Singapore Eye Research Institute.

Population

The population for this study was selected because of the high rates of myopia progression observed in Singaporean children.3, 9 Participants were recruited through the Refraction Clinics of the School Health Services and through newspaper advertisements, and any child who met the eligibility criteria could participate in the trial. Eligible children were those of Chinese

Results

As shown in Figure 1, a total of 564 eligible patients were randomized to contact lenses (281) or spectacles (283). Because of initial problems with the supply of contact lenses for the trial, a lag time existed between randomization and the initial preadaptation visit. Hence, 195 patients completed the initial visit in the contact lens group and 233 in the spectacle group (Figure 1). Of these participants, 158 in the contact lens group and 225 in the spectacle group completed the adaptation

Discussion

Based on this randomized 2-year trial, no evidence was found that rigid gas permeable (RGP) lenses reduced the progression of myopia in preadolescent school children in Singapore. Among the children with 12 or more hours per day of contact lens wear, there was a slight, but not statistically significant difference of 0.2 diopters between the rate of progression in the contact lenses compared to the spectacle group, but a substantial proportion of children were unable to adapt to or to maintain

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Orthokeratology combined with spectacles in moderate to high myopia adolescents
2024, Contact Lens and Anterior Eye
Wearing ortho-k lenses overnight may not fully correct their daytime refractory errors of adolescents with moderate to high myopia. There are three common ways to deal with the daytime residual refractive error (RRE): 1) wearing spectacles to correct the RRE; 2) wear ortho-k lenses during the daytime instead of overnight.; 3) not correcting the residual refractive error. According to previous laboratory studies, myopic peripheral refraction is associated with better myopic control. This study had two aims:1) to compare relative peripheral refractive error (RPRE) among these ways after one-month stabilization; 2) to assess the axial length changes over 2 years of ortho-k lens overnight wear combined with spectacle glasses.
This was a prospective, non-controlled, non-randomized, observational study in which a total of 27 subjects (20 females, 7 males, mean age 12.48 ± 2.23Y) with spherical equivalent refractive error from −5.00 to −8.25D were enrolled. All participants in the study wore orthokeratology (ortho-k) lenses overnight for a minimum of one month. Subsequently, their peripheral refractive error (PRE) was assessed using an open-field autorefractor. During the assessment, the participants underwent three conditions in a random order in a same morning: 1) unaided eye after orthokeratology (referred to as the Unaided-eye condition), 2) wearing glasses to correct any remaining refractive errors after orthokeratology (referred to as the Spec-RE condition), and 3) wearing ortho-k lenses during the daytime (referred to as the Continuous OK wear condition). After testing, all subjects were instructed to wear ortho-k lenses overnight and glasses during the daytime to correct their RRE for the next 2 years, during which time the progression of their axial length was followed up.
1) RPRE in either Unaided-eye or Spec-RE condition subjects were significantly more myopic than those in the Continuous OK wear condition. 2) No difference in RPRE was seen between Unaided-eye and Spec-RE conditions. 3) Axial length growth was 0.05 ± 0.20 mm and 0.17 ± 0.32 mm (mean ± standard deviation) at 1-year and 2-year follow-ups after the initial visit, respectively, which were comparable to mild myopia patients after orthokeratology. 4) After orthokeratology, axial length change had negative correlation with the initial age (p = 0.001, r = −0.616) and residual diopter (p = 0.022).
For myopes above refraction < −5.00D, wearing Ortho-k lenses overnight and glasses to correct the RRE in the daytime is recommended to ensure good visual quality and have more myopic RPRE for potential myopia control.
A comparison of vision-related quality of life between Defocus Incorporated Soft Contact (DISC) lenses and single-vision spectacles in Chinese children
2023, Contact Lens and Anterior Eye
Citation Excerpt :
Pomeda et al. surprisingly found that the rated score of handling with CLs was higher than spectacles in children, and they assumed the reason was the strong desire to use contact lenses for vision correction and enjoy the perceived convenience they provided [21]. A different study found lower handling scores with OK CLs than for spectacles; [28] a result which, while children and adolescents are reported to be competent and capable of independently managing contact lenses of all types (soft, daily disposable, rigid gas permeable and OK) [15,21,33–36], might be attributed to the strict care procedures required to maintain safety and avoid complications during wear [37]. Certainly, in the present study, enrolled participants wore DISC for 6 months without significant issues and handling scores improved by about 6.7 points per year of age, so it may not be so surprising that performance was not different between the two groups.
This study aimed to compare the vision-related quality of life (VRQoL) between Defocus Incorporated Soft Contact (DISC) lenses and single-vision spectacles in Chinese children, in order to evaluate their visual performance and subjective acceptance of this bifocal designed contact lenses treatment.
Chinese participants aged 7 to 12 years, with myopia of −4.00 to −0.75 D, astigmatism < 1.50 D, and monocular best-corrected visual acuity 0.0 or better, were recruited in the study. All participants had been wearing DISC lenses, or single-vision spectacles, for the last 6 to 18 months and were requested to complete the routine ocular examination and Chinese version of the Pediatric Refractive Error Profile (PREP 2) questionnaire. The questionnaire consisted of 7 scales: vision, symptoms, appearance, activities, handling, peer perception, and overall score. According to their habitual correction modalities, fifty-four children were allocated to the DISC group and 56 to the single-vision spectacles group. A generalized linear model was fitted to assess variables associated with the PREP 2 score.
Participants wearing DISC lenses scored significantly higher than those wearing single-vision spectacles for vision, appearance, activities, peer perception, and overall (all P < 0.05). The improvement of VRQoL in the DISC group was mainly represented in appearance, peer perception, and activities. The quality of life improved more for older participants on scales of vision, symptoms, handling, appearance, and overall score (all P < 0.05). The interaction between treatment and age was statistically significant for the activities scale (P < 0.05).
DISC lens wear significantly improves VRQoL in Chinese children compared with single-vision spectacles for most of the survey scales, especially in the areas of appearance, peer perception, and activities. The benefits provided by DISC lenses contribute to greater satisfaction than single-vision spectacles for myopic children.
Myopia Control
2023, Contact Lens Practice, Fourth Edition
Myopia is the most important cause of distance vision impairment and is fast rising in prevalence worldwide. It is estimated that by the year 2050 every 1 of 2 people will be myopic and every 1 of 10 people will be highly myopic. Contact lens-based approaches are available to slow the progression of myopia, which in turn reduces the risk of vision impairment and sight-threatening complications associated with higher levels of myopia. The chapter on ‘Myopia control with contact lenses’ provides the current understanding on the risk factors for progression, the various approaches developed so far using contact lenses to manage the progression of myopia and their efficacy in slowing myopia, and discusses the selection and fitting of individuals into these lenses.
Visual performance with multifocal corneal gas-permeable contact lenses in young adults: A pilot study
2022, Journal of Optometry
To evaluate the performance of four experimental multifocal gas permeable contact lens (MFGPCL) designs and their impact on visual function in young adults.
Seventeen young adults (age, 23.17 ± 4.48 years) enrolled in the study. Each participant was randomly assigned to wear two of four MFGPCL designs. They wore the first type of the assigned lens binocularly for one week and, after one week of washout period, wore another design on both eyes for another week. The four MFGPCL designs were as follows: design A (distance zone [DZ] 1.5 mm / add 3.0 D), B (DZ 1.5 mm / add 1.5 D), C (DZ 3.0 mm / add 3.0 D), and D (DZ 3.0 mm / add 1.5 D). Baseline visual acuity, contrast sensitivity function, and accommodation data were collected at baseline and repeated after one week of MFGPCL daily wear.
Distance and near visual acuities were not significant affected with the four MFGPCL designs. Contrast sensitivity was significantly lower in design A across all measured spatial frequencies (p < 0.05), with no significant impact from other designs on all frequencies. No significant effect was observed on accommodation measured at 33 cm (p > 0.05).
Three of the investigated MFGPCL designs preserve satisfactory visual performance. Lens design A incorporated with higher add and smaller center zone diameter had a stronger impact on the visual performance.
Vision-related quality of life of Chinese children undergoing orthokeratology treatment compared to single vision spectacles
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Citation Excerpt :
Pomeda et al. [13] reported that the rating of handling was better in the MiSight contact lens group than that in SVS group, whilst similar ratings were reported for the ortho-k and SVS groups by Santodomingo-Rubido et al. [15]. Although studies have shown that children are capable of successfully handling both soft disposable and rigid gas permeable contact lenses [26,27], undeniably, compared to spectacles, handling of ortho-k lenses and accessories requires more effort and time, even with parental help. Also, some previous studies [13,26,28], investigated daily disposable soft contact lenses use, which does not require time and effort on care procedure.
To measure and compare the vision-related quality of life between Chinese children wearing orthokeratology (ortho-k) lenses and single vision spectacles, to understand acceptance of ortho-k treatment by children in China.
Subjects of Chinese origin, with myopia of -5.00 to -0.75 D, astigmatism < 1.50 D were recruited. All subjects had been wearing optical correction – ortho-k lenses or single vision spectacles (SVS), for the past 12–18 months and were aged between 8–12 years. The Pediatric Refractive Error Profile (PREP) questionnaire, translated to Chinese, was used to evaluate the perceptions of children wearing spectacles in overall vision, near vision, far vision, symptoms, appearance, satisfaction, activities, academic performance, handling of optical corrections, and peer perceptions. PREP questions, rephrased to address the same issues for ortho-k subjects who did not wear spectacles in the daytime, were used for ortho-k wearers (PREP-OK). The mean score of all items was calculated as the overall score. For ortho-k wearers, four additional questions on experience and frequency of symptoms: experiencing difficulty in falling asleep, ocular discomfort, itchy/burning/dry eyes, and foreign body sensation during ortho-k lens wear at night were asked and reported separately.
Forty subjects (20 ortho-k, 20 SVS) completed the study. Overall vision, far vision, appearance, satisfaction, activities, and peer perception scores in the ortho-k group were significantly better than the SVS group (all P < 0.05). Handling of optical correction score in the ortho-k group was significantly worse than the SVS group (P = 0.04). No significant differences in near vision, symptoms in the daytime and academic performance were found between two groups (P > 0.05). With respect to symptoms during ortho-k lens wear at night, none of the subjects reported difficulty in falling asleep, but 30–40 % of subjects reported occasional ocular discomfort, itchy/burning/dry eyes, and foreign body sensation after lens insertion.
Although ortho-k may induce some ocular discomfort with lens wear during the night, these were infrequent and the benefits from ortho-k can compensate for the discomfort, leading to better vision-related quality of life in Chinese children, compared with those wearing SVS.
CLEAR - Evidence-based contact lens practice
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Evidence-based contact lens practice involves finding, appraising and applying research findings as the basis for patient management decisions. These decisions should be informed by the strength of the research study designs that address the question, as well as by the experience of the practitioner and the preferences and environment of the patient. This reports reviews and summarises the published research evidence that is available to inform soft and rigid contact lens history and symptoms taking, anterior eye health examination (including the optimised use of ophthalmic dyes, grading scales, imaging techniques and lid eversion), considerations for contact lens selection (including the ocular surface measurements required to select the most appropriate lens parameter, lens modality and material selection), evaluation of lens fit, prescribing (teaching self-application and removal, adaptation, care regimen and cleaning instructions, as well as minimising risks of lens wear through encouraging compliance) and an aftercare routine.

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^☆: InternetAdvance publication at ajo.com Feb 13, 2003

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Original articleA randomized trial of rigid gas permeable contact lenses to reduce progression of children’s myopia☆

Abstract

Purpose

Design

Methods

Results

Conclusions

Section snippets

Design

Setting

Population

Results

Discussion

Ophthalmic Physiol Opt

Am J Ophthalmol

Nation-wide survey of myopia among school children in Taiwan, 1986

Acta Ophthalmol Suppl

Epidemiologic study of ocular refraction among schoolchildren in Taiwan in 1995

Optom Vis Sci

Refractive errors in Singapore and Ziamen, China—a comparative study in school children aged 6 to 7 years

Optom Vis Sci

Race, culture and myopia in 110,236 young Singaporean males

Singapore Med J

The effect of having myopic parentsan analysis of myopia in three generations

Optom Vis Sci

The pattern of myopia in young Singaporean men

Singapore Med J

Refractive errors in Singapore medical students

Singapore Med J

Increasing prevalence of myopia in Singapore school children

Refractive Errors Preferred Practice Pattern

Excimer lazer photorefractive keratectomy (PRK) for myopia and astigmatism

Ophthalmology

Retinal detachment following intracapsular cataract extraction

Acta Ophthalmol

Original article
A randomized trial of rigid gas permeable contact lenses to reduce progression of children’s myopia☆