Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06344429 |
| Other study ID # |
STL_CT_0001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 20, 2023 |
| Est. completion date |
August 20, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Essilor-Polylite Taiwan Co., Ltd. |
| Contact |
Eric Tsai |
| Phone |
+886 2-2528-8001 |
| Email |
erictsai[@]essilor.com.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the
young population suffers from myopia, and almost 20% have high myopia. High myopia can easily
lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma.
In Taiwan, according to a survey by the National Health Administration, the proportion of
myopia among Grade 1 students has exceeded 81%.
There are many ways to control myopia progression. High concentrations of atropine have been
reported highly effective in the control of the myopia progression. However the accompanied
side effects such as photophobia and near blurred vision. Recent research shows that
low-concentration atropine can achieve similar control effect and more acceptable with much
minimal side effect compared to high concentration of atropine.
Multiple animal experiments have confirmed that giving retinal myopia defocus signals can
effectively decrease the growth of the eye, thereby inhibiting the progression of myopia.
Therefore, regarding lens design, myopic defocus does play an important role in myopia
control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral
defocus lenses.
Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly
aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest
significantly slowed down the myopia progression reaching 67% and retard axial elongation
reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in
controlling myopia in Taiwanese children and whether Stellest Lenses combined with
low-concentration atropine eye drops can increase the effect of myopia control.
Description:
The prevalence of myopia has been increasing in the world, especially in East Asia. The
prevalence of myopia and high myopia is estimated up to 50% and 10% of the global population,
respectively in 2050. The social economic burden of this myopia epidemic will increase
substantially, because of the risk of myopia-related complications, such as early onset of
cataract, glaucoma, myopic macular degeneration and retinal detachment. The use of myopia
control interventions in school myopia can help reduce severity of myopia in the further life
of this population with potential reduce of the risk of these pathologies.
There are several ways to control school myopia progression. High concentrations of atropine
have been reported highly effective in the control of the myopia progression. However the
accompanied side effects such as photophobia and near blurred vision. Recent research shows
that low-concentration atropine can achieve similar control effect and more acceptable with
much minimal side effect compared to high concentration of atropine.
Research in animal models has shown that imposed myopic optical defocus in peripheral retina,
the focal plane in front of the retina, has an inhibitory effect on eye growth to stop myopia
progression. Recently, it has been reported that spectacle lenses with aspherical lenslets
with myopic defocus (Stellest™ lenses) effectively slow myopia progression reaching 67% and
retard axial elongation reaching 64% compared with single vision lenes in 1 year study.
The purpose of this study is to compare the effect of the Stellest lenses, 0.05% atropine and
combined treatment for the myopia control in Taiwanese children.
Method： This study will be conducted 2 years at the Kaohsiung Chang Gung Memorial Hospital,
Taiwan. Children aged 6 to 12 years old with myopic refraction of at least -0.75 D in both
eyes, astigmatism of less than -2.5 D, were enrolled in this open label, randomized study.
Excluded were those with ocular diseases (e.g., cataract, congenital retinal diseases,
amblyopia, and strabismus), previous use of atropine, or orthokeratology lens orother optical
methods for myopia control within 6 months, allergy to atropine, or systemic diseases (e.g.,
endocrine, cardiac, and respiratory diseases). Written informed consent will be obtained from
parents or guardians and the participants. The study will be sent to the Ethics Committee of
the Chang Gung Memorial Hospital and will be registered with the ClinicalTrials.gov Registry,
the Kaohsiung Chang Gung Memorial Hospital (registration no:). All procedures are conducted
according to the tenets of the Declaration of Helsinki.
100 Participants in this study were randomized to receive Stellest lenses spectacle (ST)
(N=34), 0.05% atropine with single vision lenses (ASV) (N=33) and combined treatment (STA)
(N=33). 0.05% atropine eye drops is dropped once nightly in both eyes in ASV and STA group.
The gender and age are balanced across the 3 treatment arms. The trial medications were
prepackaged identically with the number of study subjects and the expiration date. Expiry
duration for the batch of eye drops was 2 years.
All subjects are recruited and randomized to 3 treatment groups at the baseline visit. Boys
and girls are recruited to have a balance in gender. All subjects are then followed up on the
same schedule with the same examination protocol: at 2 weeks (monitor visit), 6 months, and
12 months from the baseline visit. The purpose of the monitor visit at 2 weeks was to
determine the hyperopic shift, if any, that has been reported in a higher concentration of
atropine in the previous studies.
At each visit, distant best-corrected visual acuity (BCVA) in was assessed by an optic
technician using the Landolt C chart and Optical Coherence Tomography (OCT) by well-trained
an study team staff. Near visual acuity was assessed using best-corrected distance spectacle
correction with a reduced logMAR reading chart placed at 40 cm under well-lit conditions. The
near point of accommodation was measured using a Royal Air Force (RAF) near point rule
(Harlow, Essex, UK) with best-corrected distance spectacle correction.
Participants were instructed to move the target inward until the N5 print became slightly
blurred and then outward until it just became clear. Accommodation amplitude was calculated
as the inverse of the near point of accommodation.
Mesopic pupil size and photopic pupil size were measured. Cycloplegic autorefraction was
performed using an autorefractor after the tropicamide regimen, which consisted of at least 3
cycles of eye drops. At the first cycle, 2 separate eye drops, tropicamide 1%, were
administered to both eyes at 5 minutes apart. A 2nd and 3rd cycle of the same cycloplegic
drops would be administered 10 minutes after the previous cycle. If the pupil size was less
than 6.0 mm, further cycles of cycloplegic eye drops would be administered if necessary to
ensure the pupils are well dilated. Five readings, all of which had to be less than 0.25 D
apart, were obtained and averaged. Spherical equivalent (SE) was calculated as spherical
power plus half of the cylinder power. Ocular AL was measured by on noncontact partial
coherence interferometry and optic coherencetomography. Five readings, with a maximum-minimum
deviation of 0.05 mm or less, were taken and averaged. A diary on the trial medication was
kept for each subject. Compliance level of each subject was classified according to the mean
number of using atropine per week as reported by participants over the 12 months. Subjects
with 75% compliance rate (i.e., a mean of 5.25 days/week) were considered to have good
compliance. Subjects were also offered sunwear orsunglasses or (which darken on exposure to
ultraviolet or sunlight) if they experienced glare or if their parents were worried of
excessive light exposure, or progressive glasses (reading add) if they experienced difficulty
with near vision. All subjects were prescribed with best-corrected spectacles.
At the baseline, validated questionnaires on outdoor time and near work were administered to
parents. In addition, children wear outdoor time smartwatch for 1 week to evaluation the
outdoor time every day in the baseline, 6-month F/U and 12-month F/U. Outdoor activities
includes time spent on sports and leisure, whereas near works included time on homework, cell
phone, computer, video games, and watching TV. Parental refraction is documented by
noncycloplegic autorefraction measurement, for both parents of each child at baseline. At the
12-month follow-up visit, the Chinese version of the 25-Item National Eye Institute Visual
Function Questionnaire was administered to all subjects to determine the impact of different
treatment groups on the vision-related quality of life.
A total of 11 subscales are addressed: general health, general vision, ocular pain, near
vision, distance vision, social function, mental health, role limitations, dependency, color
vision, and peripheral vision. Driving is excluded.
The primary outcome was myopia progression in terms of SE change over 1 year. Myopia
progression in each eye was further categorized as mild (<0.5 D), moderate (0.5-0.99 D), or
severe (≥1.0 D). The secondary outcomes included AL change at 1 year. Side effect parameters
included changes in accommodation amplitude, mesopic and photopic pupil sizes, and distant
BCVA and near visual acuity. All ophthalmic parameters, including SE, AL, accommodation,
pupil size, and visual acuity, were monitored from baseline.
During each visit, subjects and parents were given an open-ended opportunity to report any
medical illness or adverse events. They were also specifically asked about symptoms related
to allergy, blurred near vision, glare, or visual loss, and if subjects had been ill or
hospitalized since the previous visit. Adverse events (AEs) will be followed, recorded, and
reported in the CRF throughout the entire study and only relevant to spectacle or atropine
used signs and symptoms. The investigator will assess the severity (intensity) of each AE as
mild, moderate or severe, and will also categorize each AE as to its potential relationship
to IP (0.05% atropine or Stellest Lenses) using the categories of yes or no.
An Serious Adverse Events (SAE)，an SAE is any event that meets any of the following criteria:
Results in death, is life-threatening, requires inpatient hospitalization or prolongation of
existing hospitalization, results in persistent or significant disability/incapacity, is a
congenital anomaly/ birth defect, is important medical event. Investigator is obliged to
respond and meet strict regulatory and IRB timelines associated with expedited reporting
obligations for events of this nature. Relevant SAE reporting and follow up information
should be notice sponsor immediately and file it along.
Confidentiality and Data Management All information generated in this study is considered
highly confidential and must not be disclosed to any person or entity directly involved with
the study unless prior written consent is gained from the sponsor. However, authorized
regulatory officials, IRB personnel, the sponsor, and its authorized representatives are
allowed full access to the records.
All study subjects and legal representative must be informed that their personal
study-related data will be used by the sponsor in accordance with local data protection law
and the General Data Protection Regulation. The level of disclosure must also be explained to
the subject and legal representative, who will be required to give consent for their data to
be used as described in the ICF. The subject and legal representative must be informed that
medical records may be examination by auditors or other authorized personnel appointed by the
sponsor, by appropriated IRB members, and by inspectors from regulatory authorities.
Identification of subjects and CRFs shall be by unique subject identification numbers only.
All personal identifiers according to applicable regulations (eg, number, phone number) must
be redacted permanently by the site personnel and replaced with the subject's unique
identification member in all records and data before transfer to the sponsor (or designee).
All personnel details will be treated as confidential by the investigator and staff.
Statistical Analysis： All data were analyzed based on the intention-to-treat principle.
Change of parameters was defined by the difference between the baseline and the corresponding
follow-up values. Chi-square test and Fisher exact test were used to test the group
difference in categoric data. Analysis of variance was used to test the group difference of
continuous data. SPSS software was used for data analyses. P value < 0.05 was considered
statistically significant.
