Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery: A Randomized Clinical Trial
Phase: NA
Conditions: Pediatric Cataract, IOL Implantation, Myopia Progression
Sponsor: Cairo University

                                                                                                            
Research Template 
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Faculty of Medicine, Cairo University Postgraduate 
Research Protocol Template 
 
1. Study 
 
a- Proposed Study Title:  Myopia Progression Control Using Atropine 0.05% After 
Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery: A 
Randomized Clinical Trial. 
b- Degree:   MD Degree 
c- Date of Registration of MD: 10/2025 
 
     2. Candidate 
a. Name: Rawan Mohamed Hassan Mohamed Hussein Hosny  
b. Occupation: Ophthalmology Specialist 
c. Affiliation: Cairo University – Kasr Al Ainy Hospital 
d. Email addresses: rawanm.hosny@gmail.com 
e. Full mailing address: 97R Mountain View Giza Plateau, Alex. Desert road 
f. 
Phone number: +201005556839 
3. Supervisors Contact Information 
  
a.   Principal supervisor:   Name: Prof Dr Ghada Gawdat 
                                         Department: Ophthalmology 
    Phone number: 01002581682 
    E-mail: ghadagawdt@yahoo.co.in 
 
b.  Other supervisors: 
 
1- Name: Prof Dr Ahmed Awadein 
    Department: Ophthalmology 
    Phone: 01223911743         
    Email: ahmedawadein@yahoo.com 
2- Name: Prof Dr Dina El Fayoumy 
    Department: Ophthalmology 
    Phone:01006044030 
    Email: d_elfayoumi@yahoo.com  

                                                                                                            
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4. Scientific committee approval  
Date of approval: 01/05/2026 
 
5. Background and Rationale: 
    Cataract is a leading cause of visual impairment in the pediatric age group, with 
an annual incidence of 1.8 to 3.6 per 10,0001. The visual morbidity is not only due to 
media opacity caused by the cataracts, but also secondary to long lasting effects 
following cataract extraction, with timing and biometric aim of IOL implantation 
procedure presenting a unique challenge2. 
Normal ocular growth is characterized by axial length elongation along with corneal 
and lenticular flattening with a net refractive shift of approximately -0.9D3,4. Cataract 
surgery in infants interrupts normal emmetropization of eyes and can lead to large 
myopic shift which may reach over 10 D5. 
Myopia is an epidemic with an estimated increase in prevalence to 50% by 20256. 
Rapidly progressing myopia significantly increases risk of permanent visual loss due 
to several ocular complications as maculopathy, retinal detachment and glaucoma7.  
Strategies for myopia control and prevention involve both optical and 
pharmacological measures, with atropine being a cornerstone in myopia 
management8. Initially, it was believed that atropine limits myopia progression via 
blocking accommodation. Recently, however, it has been shown that atropine 
functions via a non-accommodative pathway9. It is hypothesized that atropine exerts 
its action via regulation of dopamine release in retinal amacrine cells, which leads to 
reduction of rate of axial growth of eye10. Another plausible mechanism is that up- 
and down-regulation of scleral muscarinic receptors influences scleral matrix 
deposition11.  Multiple low-dose concentrations have been studied, with older age 
and lower grades of myopia showing better response. Younger age requires the 
highest available concentration (0.05) to achieve adequate response12.  
While research exploring peripheral myopic defocus for post-cataract surgery 
myopia prevention shows promising results13, the use of multifocal intra-ocular 
lenses (IOLs) cannot be used liberally in countries with high disease burden and 
challenged economies due to high price and decreased availability. To date there 
are no studies evaluating the use of topical atropine for the management of myopic 
shift following pediatric cataract surgery.  
We aim to explore the use of 0.05% topical atropine in the prevention and 
management of myopic shift following pediatric cataract surgery. 
 

                                                                                                            
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6. Objectives:  
 
-Primary objective: 
To evaluate the effect of atropine eye drops 0.05% on myopia progression in 
unilateral and bilateral cases of pseudophakia. 
 
-Secondary objective:  
To evaluate side effects of atropine use as mydriasis leading to photophobia, 
blurring, and local allergic responses, rebound of myopia after cessation of atropine. 
 
  
7. Study Design: 
Randomized clinical trial  
Study Methods 
Population of study: The study will be performed on pediatric patient who underwent 
primary or secondary intraocular lens (IOL) implantation. 
Study location: The study will be carried out in the Cairo University Pediatric 
Ophthalmology and Strabismology unit, Abu El Rish.  
 
Inclusion criteria:  
1) Children after IOL implantation (primary or secondary)  
2) Age 1-7 years 
 
Exclusion criteria: 
1) Eyes with post-operative media opacity hindering adequate assessment of 
refraction 
2) Eyes with complicated surgeries (e.g. vitreous loss, dropped lens matter 
requiring PPV, retinal detachment, etc)  
3) Retinal pathologies 
4) Glaucoma (congenital or secondary to surgery) 
5) Anterior or posterior segment anomalies  
 
Methodology in detail: 
All guardians of the selected patients will receive a thorough explanation of the study 
design and aims and will sign an informed consent. 

                                                                                                            
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Baseline pre-treatment evaluation: 
Ophthalmological:  
- 
Cycloplegic refraction using both manual retinoscopy and 
autorefractometer – N.B. target refraction following surgery is 
adjusted to according to age (+4.00 at 1 year, +2-3 at 2-5 years 
and 0 above 5 years of age.)   
- 
Corrected distance visual acuity (CDVA) whenever possible 
- 
Slip lamp examination  
- 
Intraocular pressure measurement using Perkin’s applanation 
tonometry. 
- 
Dilated fundus examination by binocular indirect ophthalmoscopy. 
- 
Evaluation of extraocular motility and muscle balance. 
- 
Stereopsis using Titmus test whenever possible 
- 
Axial length measurement 
o Optical biometry (at least 5 measurements) in cooperative 
children  
o If child is uncooperative, A-scan ultrasonography via 
contact method, by 2 different observers 
- 
Time spent outdoors and time of near work. 
 
 
Randomization will be done by closed envelope technique and study participants will 
be divided into 2 groups: group A will receive the atropine eye drops 0.05% once per 
day and group B will receive placebo eye drops. Patients with bilateral surgery will 
receive atropine 0.05% in both eyes or placebo eyedrops in both eyes. Patients with 
unilateral pseudophakia will be randomized either atropine or placebo eyedrops. 
 
Atropine 0.05% ED will be prepared by one specialized pharmacy (BKC Company, 
registration number Toll/332) and provided by Cairo University Pediatric 
Ophthalmology and Strabismology unit, Abu El Rish with monthly refills.  
 
The study will be double masked as the investigators and patients will be blinded as 
regards the 2 groups. (to ensure no bias in the assessment by the investigators). 
The study period is to be 12 months.  
 

                                                                                                            
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Follow up will be done at 6 weeks, 3, 6 ,9, 12 months: at each follow up the following 
will be assessed: 
- 
Cycloplegic refraction manual retinoscopy and autorefractometer 
-           Corrected distance visual acuity (CDVA) whenever possible 
- 
Stereopsis using Titmus test whenever possible 
- 
Ocular muscle balance. 
- 
Axial length measurement 
o Optical biometry (at least 5 measurements) in cooperative 
children  
o If child is uncooperative, A-scan ultrasonography via 
contact method, by 2 different observers 
. 
- 
Time spent outdoors and time of near work. 
- 
Compliance (measured in days atropine used per week) 
 
The research involves: 
 Human participants 
  
Type of consent of study participants: 
 Written consent 
    
 Potential risks:  
Risks of treatment:  Mydriasis leading to photophobia, and local allergic responses, 
rebound of myopia after cessation of atropine. 
 
Confidentiality of data:  
All participants will be coded, and data entry will occur using these codes. All  
data of the patients will be saved in secure files. 
      9- Study outcomes:  
Primary outcomes: 
1- Change in spherical equivalent measured in diopters in each group. 
2- Change in axial length measured in millimeters in each group. 
 
  Secondary outcome parameters (other outcomes to be assessed) 
1- Side effects of atropine use as mydriasis leading to photophobia, blurring, 
and local allergic responses, rebound of myopia after cessation of atropine. 

                                                                                                            
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           10- Sample size: 
Sample size was calculated based on a recent study comparing axial length 
changes following pediatric IOL implantation using monofocal and multifocal IOLs13 
as no studies comparing atropine use following pediatric cataract surgery exists. The 
effect size was estimated 0.78 and accordingly a total of 44 eyes were calculated 
using G*power (3.1.9.4) software, the power being 0.8. The Type I error probability 
associated with this test of the null hypothesis is 0.05. With dropout rate 10%, 
sample size will be 50 eyes, 25 in each group.   
11- Statistical analysis 
The collected data will be statistically analyzed using SPSS program (Statistical 
Package for Social Science) version 26. 
 
    A. Descriptive statistics:  
Quantitative data will be expressed as mean and SD while qualitative data will be   
represented in tables as frequencies and percentages. 
 
    B. Analytical statistics:  
1) 
Student t test will be used for comparing quantitative data. It is considered 
statistically significant at P-value < 0.05. 
2) 
Chi-square test will be used for qualitative data. It is considered statistically 
significant at P-value < 0.05 
 
         12- Source of funding: Cairo University Ophthalmology 
                Faculty of Medicine, Cairo University  

                                                                                                            
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      14- References:  
1. Sheeladevi S, Lawrenson JG, Fielder AR, Suttle CM. Global prevalence of childhood 
cataract: a systematic review. Eye Lond Engl. 2016;30(9):1160-1169. 
doi:10.1038/eye.2016.156 
2. Magli A, Forte R, Rombetto L. Long-term outcome of primary versus secondary 
intraocular lens implantation after simultaneous removal of bilateral congenital cataract. 
Graefes Arch Clin Exp Ophthalmol. 2013;251(1):309-314. doi:10.1007/s00417-012-
1979-7 
3. Gordon RA, Donzis PB. Refractive development of the human eye. Arch Ophthalmol 
Chic Ill 1960. 1985;103(6):785-789. doi:10.1001/archopht.1985.01050060045020 
4. Valeina S, Heede S, Erts R, et al. Factors influencing myopic shift in children after 
intraocular lens implantation. Eur J Ophthalmol. 2020;30(5):933-940. 
doi:10.1177/1120672119845228 
5. McClatchey SK, Parks MM. Myopic Shift After Cataract Removal in Childhood. J Pediatr 
Ophthalmol Strabismus. 1997;34(2):88-95. doi:10.3928/0191-3913-19970301-07 
6. Medina A. The cause of myopia development and progression: Theory, evidence, and 
treatment. Surv Ophthalmol. 2022;67(2):488-509. 
doi:10.1016/j.survophthal.2021.06.005 
7. Bullimore MA, Ritchey ER, Shah S, Leveziel N, Bourne RRA, Flitcroft DI. The Risks and 
Benefits of Myopia Control. Ophthalmology. 2021;128(11):1561-1579. 
doi:10.1016/j.ophtha.2021.04.032 
8. Chen JW, Lu CJ, Yu CH, Liu TC, Wu TE. Decision Tree Modeling to Predict Myopia 
Progression in Children Treated with Atropine: Toward Precision Ophthalmology. 
Diagnostics. 2025;15(16):2096. doi:10.3390/diagnostics15162096 
9. Kaiti R, Shyangbo R, Sharma IP. Role of Atropine in the control of Myopia Progression- A 
Review. Beyoglu Eye J. 2022;7(3):157-166. doi:10.14744/bej.2022.07742 
10. Read SA, Alonso-Caneiro D, Vincent SJ, Collins MJ. Longitudinal changes in choroidal 
thickness and eye growth in childhood. Invest Ophthalmol Vis Sci. 2015;56(5):3103-
3112. doi:10.1167/iovs.15-16446 

                                                                                                            
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11. Barathi VA, Beuerman RW. Molecular mechanisms of muscarinic receptors in mouse 
scleral fibroblasts: Prior to and after induction of experimental myopia with atropine 
treatment. Mol Vis. 2011;17:680-692. 
12. Li FF, Zhang Y, Zhang X, et al. Age Effect on Treatment Responses to 0.05%, 0.025%, 
and 0.01% Atropine: Low-Concentration Atropine for Myopia Progression Study. 
Ophthalmology. 2021;128(8):1180-1187. doi:10.1016/j.ophtha.2020.12.036 
13. Du Q, Zhang Y, Huang Y. Peripheral Refraction and Axial Growth Rate After Multifocal 
or Monofocal Intraocular Lens Implantation in Chinese Pediatric Cataract Patients. 
Invest Ophthalmol Vis Sci. 2025;66(2):33. doi:10.1167/iovs.66.2.33 
 
    
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