Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-25 @ 6:05 PM
Study NCT ID:
NCT07164092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
This randomized controlled trial aims to evaluate the efficacy and safety of low-dose topical atropine sulphate (0.05%), a non-selective muscarinic antagonist, in slowing the progression of myopia and ocular axial elongation in children. The study will be conducted at Mansoura Ophthalmic Center, Mansoura University, Egypt, from October 2025 to october 2027.
Eligible participants are myopic children attending the outpatient clinic during the study period. Participants will be stratified into three groups according to baseline myopia severity (low, moderate, and high). Each child will be randomized to receive one drop of atropine 0.05% in one eye and one drop of placebo in the fellow eye nightly for 24 months. The allocation of treatment to right or left eye will be randomized to avoid laterality bias.
Study Outcomes
* Primary Outcome
o Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation.
* Secondary Outcomes
* Change in spherical equivalent refraction (SER), measured by cycloplegic autorefraction using a Topcon KR-800 autorefractor after standard cycloplegia with cyclopentolate 1%.
* Best-corrected distance visual acuity (BCVA).
* Sample Size
The primary endpoint of this trial is the change in ocular axial length (AL) over 24 months, analyzed as a paired comparison between the atropine-treated and placebo-treated eyes within each child.
Sample size estimation was based on previously published data reporting mean axial elongation of 0.115 ± 0.11 mm in atropine-treated eyes compared with 0.303 ± 0.12 mm in placebo-treated eyes, yielding a mean difference of 0.188 mm. Assuming an inter-eye correlation of 0.6, the standard deviation of the paired difference is estimated at approximately 0.10 mm, giving an effect size of d = 1.88. Using a two-tailed paired t-test with α = 0.05 and 90% power, the minimum required sample size is 12 children.
Eligible participants are myopic children attending the outpatient clinic during the study period. Participants will be stratified into three groups according to baseline myopia severity (low, moderate, and high). Each child will be randomized to receive one drop of atropine 0.05% in one eye and one drop of placebo in the fellow eye nightly for 24 months. The allocation of treatment to right or left eye will be randomized to avoid laterality bias.
Study Outcomes
* Primary Outcome
o Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation.
* Secondary Outcomes
* Change in spherical equivalent refraction (SER), measured by cycloplegic autorefraction using a Topcon KR-800 autorefractor after standard cycloplegia with cyclopentolate 1%.
* Best-corrected distance visual acuity (BCVA).
* Sample Size
The primary endpoint of this trial is the change in ocular axial length (AL) over 24 months, analyzed as a paired comparison between the atropine-treated and placebo-treated eyes within each child.
Sample size estimation was based on previously published data reporting mean axial elongation of 0.115 ± 0.11 mm in atropine-treated eyes compared with 0.303 ± 0.12 mm in placebo-treated eyes, yielding a mean difference of 0.188 mm. Assuming an inter-eye correlation of 0.6, the standard deviation of the paired difference is estimated at approximately 0.10 mm, giving an effect size of d = 1.88. Using a two-tailed paired t-test with α = 0.05 and 90% power, the minimum required sample size is 12 children.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: