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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10EY011751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Pediatric Eye Disease Investigator Group | NETWORK |
| National Eye Institute (NEI) | NIH |
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Study Objectives
The objectives for this randomized trial are:
Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Study Objectives
The objectives for this randomized trial are:
Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine Group | Experimental | 0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops |
|
| Placebo Group | Placebo Comparator | Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | Daily 0.01% atropine eyedrops |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | At 24 months |
| Primary Outcome Measure Stratified by Sex | NIH-required analysis. Primary outcome measure (stratified by sex): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | at 24 months |
| Primary Outcome Measure Stratified by Race | NIH-required analysis. Primary outcome measure (stratified by race): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | by 24 months |
| Primary Outcome Measure Stratified by Ethnicity |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent | Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months. | At 30 months |
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Inclusion Criteria:
Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
Refractive error meeting the following by cycloplegic autorefraction:
Gestational age ≥ 32 weeks.
Birth weight >1500g.
Parent understands the protocol and is willing to accept randomization to atropine or placebo.
Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
Able to return in 2 to 4 weeks for possible randomization.
Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.
Exclusion Criteria:
Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
Known atropine allergy.
Abnormality of the cornea, lens, central retina, iris or ciliary body.
Current or prior history of manifest strabismus, amblyopia, or nystagmus.
Prior eyelid, strabismus, intraocular, or refractive surgery.
Down syndrome or cerebral palsy.
Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.
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| Name | Affiliation | Role |
|---|---|---|
| Michael X Repka, MD, MBA | Wilmer Eye Institute | Study Chair |
| Katherine K Weise, OD, MBA | University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| The Emory Eye Center Dept of Ophthalmology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37440213 | Result | Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855. | |
| 39480129 | Derived |
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In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
After completion of the protocol and publication of the primary manuscript, the data will be made available for the duration of the grant and any future grants.
Users accessing the data must enter an email address.
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Two hundred patients were enrolled into the run-in phase; 13 were ineligible for randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Atropine Group | 0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops Atropine: Daily 0.01% atropine eyedrops |
| FG001 | Placebo Group | Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops Placebo Eyedrops: Daily placebo eyedrops |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atropine Group | 0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops Atropine: Daily 0.01% atropine eyedrops |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | Posted | Count of Participants | Participants | At 24 months |
|
Adverse event data was collected for the duration of the study, baseline to 30 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atropine Group | 0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops Atropine: Daily 0.01% atropine eyedrops |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | Hospitalization for issues unrelated to the study, two hospitalizations include: one participant undergoing hip surgery for a pre-existing condition; one participant hospitalized for COVID-19. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritiation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Kraker, PEDIG Coordinating Center Director | Jaeb Center for Health Research | 8139758690 | rkraker@jaeb.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2020 | Dec 28, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2022 | Dec 28, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2019 | Aug 27, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Not provided
Not provided
Cycloplegic autorefraction, axial length, and additional biometry will be measured by a masked examiner at all follow-up visits using the same instrumentation on the participant throughout the study. Masking will be accomplished by having site personnel administer cyclopentolate to both eyes of each participant and wait 30 minutes before he/she sees the masked examiner. The masked examiner may be a technician or an investigator and must be certified to complete these measurements. Parents, patients, and investigators are also masked to treatment.
| Placebo Eyedrops | Other | Daily placebo eyedrops |
|
NIH-required analysis. Primary outcome measure (stratified by ethnicity):
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison).
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
| at 24 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| St Luke's Hospital | Boise | Idaho | 83702 | United States |
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
| Ticho Eye Associates | Chicago Ridge | Illinois | 60415 | United States |
| Boston Children's Hospital Waltham | Boston | Massachusetts | 02453 | United States |
| Pediatric Ophthalmology Associates, Inc. | Columbus | Ohio | 43205 | United States |
| Eye Care Associates, Inc. | Poland | Ohio | 44514 | United States |
| Dean A. McGee Eye Institute, University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Vanderbilt University Medical Center - Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | United States |
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
| Rocky Mountain Eye Care Associates | Salt Lake City | Utah | 84107 | United States |
| Weise KK, Repka MX, Zhu Y, Manny RE, Raghuram A, Chandler DL, Summers AI, Lee KA, Kehler LAF, Pang Y, Allen MS, Anderson HA, Erzurum SA, Golden RP, Koutnik CA, Kuo AF, Lenhart PD, Mokka PL, Petersen DB, Ticho BH, Wiecek EK, Yin H, Beaulieu WT, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Baseline factors associated with myopia progression and axial elongation over 30 months in children 5 to 12 years of age. Optom Vis Sci. 2024 Oct 1;101(10):619-626. doi: 10.1097/OPX.0000000000002187. |
| Moved residence |
|
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Eye Color | Count of Participants | Participants |
|
| Number of Biological Parents with Myopia | Count of Participants | Participants |
|
| Current Refractive Correction (Single-vision Spectacles or Contact Lenses) | Count of Participants | Participants |
|
| Distance Visual Acuity in Habitual Refractive Correction (Mean of Both Eyes) | Count of Participants | Participants |
|
| Mean OD and OS Flat Corneal Radius | Flat corneal radius was not available for 1 patient in the placebo group. | Mean | Standard Deviation | Diopters squared |
|
| Mean OD and OS Anterior Chamber Depth | Mean | Standard Deviation | millimeter |
|
| Mean OD and OS Lens Thickness | Lens thickness was not available for some patients (N=53 in atropine and N=27 in placebo) because the biometer used did not provide a lens thickness reading due to measurement difficulty. | Mean | Standard Deviation | millimeters cubed |
|
| OG001 | Placebo Group | Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops Placebo Eyedrops: Daily placebo eyedrops |
|
|
|
| Secondary | Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent | Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months. | Posted | Count of Participants | Participants | At 30 months |
|
|
|
|
| Primary | Primary Outcome Measure Stratified by Sex | NIH-required analysis. Primary outcome measure (stratified by sex): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit. | Posted | Mean | Standard Deviation | Diopters | at 24 months |
|
|
|
| Primary | Primary Outcome Measure Stratified by Race | NIH-required analysis. Primary outcome measure (stratified by race): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit. | Posted | Mean | Standard Deviation | Diopter | by 24 months |
|
|
|
| Primary | Primary Outcome Measure Stratified by Ethnicity | NIH-required analysis. Primary outcome measure (stratified by ethnicity): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. | 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit. | Posted | Mean | Standard Deviation | Diopters | at 24 months |
|
|
|
| 0 |
| 125 |
| 2 |
| 125 |
| 109 |
| 125 |
| EG001 | Placebo Group | Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops Placebo Eyedrops: Daily placebo eyedrops | 0 | 62 | 0 | 62 | 56 | 62 |
|
| Photophobia | Eye disorders | Systematic Assessment |
|
| Vision Blurred | Eye disorders | Systematic Assessment |
|
| Allergic Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Ocular Discomfort | Eye disorders | Systematic Assessment |
|
| Visual Impairment | Eye disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Hordeolum | Eye disorders | Systematic Assessment |
|
| Accommodation Disorder | Eye disorders | Systematic Assessment |
|
| Optic Disc Drusen | Eye disorders | Systematic Assessment |
|
| Headache | Eye disorders | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
|
| Vitreous Floaters | Eye disorders | Systematic Assessment |
|
| Eye injury | Eye disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Retinal degeneration | Eye disorders | Systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | Systematic Assessment |
|
| Foreign body in eye | Eye disorders | Systematic Assessment |
|
| Meibomianitis | Eye disorders | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
|
| Dermatitis contact | Eye disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Pruritus | Eye disorders | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Chalazion | Eye disorders | Systematic Assessment |
|
| Mydriasis | Eye disorders | Systematic Assessment |
|
| Corneal Scar | Eye disorders | Systematic Assessment |
|
Not provided
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| >-3.00 to -2.50 Diopters |
|
| >-2.50 to -2.00 Diopters |
|
| >-2.00 to -1.50 Diopters |
|
| >-1.50 to -1.00 Diopters |
|
| >-1.00 to -0.50 Diopters |
|
| >-0.50 to 0.00 Diopters |
|
| >0 Diopters |
|
| Male |
|
|
| Black/African American |
|
|
| Asian |
|
|
| More than one race |
|
|
| Unknown/not reported |
|
|
| Hispanic or Latino |
|
|