search
Back to results

Low-dose Atropine for the Prevention of Myopia Progression in Danish Children (APP)

Primary Purpose

Myopia

Status
Active
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
0.1% atropine and 0.01% atropine
0.01% atropine
0.9% Sodium-chloride
Sponsored by
Line Kessel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye
  • Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye
  • Cylinder less than 1.5 diopters

Exclusion Criteria:

  • Myopia related to retinal dystrophies
  • Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
  • Other ocular pathology (e.g., amblyopia, strabismus)
  • Previous eye surgery
  • Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
  • Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
  • Non-compliance to eye examinations
  • Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays

Sites / Locations

  • Department of Ophthalmology, Aarhus University Hospital
  • Department of Ophthalmology, Rigshospitalet-Glostrup
  • Department of Ophthalmology, Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Loading dose

Low dose

Placebo

Arm Description

In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Outcomes

Primary Outcome Measures

Change in axial length
Treatment group comparison of change in axial length elongation from baseline to 36 months, as measured using IOLMaster 700
Change in spherical equivalent
Treatment group comparison of change in spherical equivalent from baseline to 36 months, as measured using cycloplegic autorefraction

Secondary Outcome Measures

Adverse effects and reactions
Treatment group comparison of adverse effects and reactions
Change in choroidal thickness
Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)
Change in ocular biometry
Treatment group comparison of change in ocular biometry (i.e. keratometry, anterior chamber depth, lens thickness, vitreous axial distance) from baseline to 36 months
Change in higher-order aberrations
Treatment group comparison of change in higher-order aberrations from baseline to 36 months

Full Information

First Posted
April 2, 2019
Last Updated
July 6, 2021
Sponsor
Line Kessel
Collaborators
Aarhus University Hospital, Vejle Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03911271
Brief Title
Low-dose Atropine for the Prevention of Myopia Progression in Danish Children
Acronym
APP
Official Title
Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Line Kessel
Collaborators
Aarhus University Hospital, Vejle Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.
Detailed Description
The main hypotheses tested in this study are: 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children. 0.01% atropine one drop nightly is safe and with no significant side effects. A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine. 0.1% atropine one drop nightly is safe and has tolerable side effects. The rebound effect after stopping both atropine regimens is limited. Choroidal thickness is a predictor for the progression of childhood myopia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loading dose
Arm Type
Experimental
Arm Description
In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Arm Title
Low dose
Arm Type
Experimental
Arm Description
In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Intervention Type
Drug
Intervention Name(s)
0.1% atropine and 0.01% atropine
Other Intervention Name(s)
Loading dose
Intervention Description
0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
Intervention Type
Drug
Intervention Name(s)
0.01% atropine
Other Intervention Name(s)
Low-dose
Intervention Description
0.01% atropine for 24 months
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium-chloride
Other Intervention Name(s)
Placebo
Intervention Description
Placebo for 24 months
Primary Outcome Measure Information:
Title
Change in axial length
Description
Treatment group comparison of change in axial length elongation from baseline to 36 months, as measured using IOLMaster 700
Time Frame
36 months
Title
Change in spherical equivalent
Description
Treatment group comparison of change in spherical equivalent from baseline to 36 months, as measured using cycloplegic autorefraction
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Adverse effects and reactions
Description
Treatment group comparison of adverse effects and reactions
Time Frame
36 months
Title
Change in choroidal thickness
Description
Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)
Time Frame
36 months
Title
Change in ocular biometry
Description
Treatment group comparison of change in ocular biometry (i.e. keratometry, anterior chamber depth, lens thickness, vitreous axial distance) from baseline to 36 months
Time Frame
36 months
Title
Change in higher-order aberrations
Description
Treatment group comparison of change in higher-order aberrations from baseline to 36 months
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye Cylinder less than 1.5 diopters Exclusion Criteria: Myopia related to retinal dystrophies Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome) Other ocular pathology (e.g., amblyopia, strabismus) Previous eye surgery Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study Non-compliance to eye examinations Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays
Facility Information:
Facility Name
Department of Ophthalmology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Department of Ophthalmology, Rigshospitalet-Glostrup
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark
Facility Name
Department of Ophthalmology, Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

We'll reach out to this number within 24 hrs