Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344429
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-20
Brief Title:
Stellest Lenses and Low-concentration Atropine Myopia Control Among Children
Sponsor:
Essilor-Polylite Taiwan Co Ltd
Organization:
Essilor-Polylite Taiwan Co Ltd
Study Overview
Official Title:
Exploring the Effects of Treatment With Stellest Lenses and Low-concentration Atropine for Myopia Control Among Children
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 005 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 -075 D in both eyes astigmatism of less than -25 D were enrolled in this open label randomized study Excluded were those with ocular diseases eg 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 eg 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 ClinicalTrialsgov 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 N34 005 atropine with single vision lenses ASV N33 and combined treatment STA N33 005 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 60 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 025 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 005 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 ie a mean of 525 daysweek 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 FU and 12-month FU 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 05 D moderate 05-099 D or severe 10 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 005 atropine or Stellest Lenses using the categories of yes or no
An Serious Adverse Events SAEan 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 disabilityincapacity 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 subjects 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 005 was considered statistically significant
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 005 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 -075 D in both eyes astigmatism of less than -25 D were enrolled in this open label randomized study Excluded were those with ocular diseases eg 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 eg 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 ClinicalTrialsgov 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 N34 005 atropine with single vision lenses ASV N33 and combined treatment STA N33 005 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 60 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 025 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 005 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 ie a mean of 525 daysweek 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 FU and 12-month FU 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 05 D moderate 05-099 D or severe 10 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 005 atropine or Stellest Lenses using the categories of yes or no
An Serious Adverse Events SAEan 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 disabilityincapacity 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 subjects 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 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None