Pediatric CataractNCT07364370
Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery
A study testing Atropine Eye drops in people with Pediatric Cataract and IOL Implantation, run by Cairo University at 1 site in Egypt.
Trial summary
Myopic shift remains a debilitating and unpredictable adverse event following pediatric cataract surgery. While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, the use of multifocal intra-ocular lenses (IOLs) cannot be used liberally in countries with… Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pediatric Cataract, IOL Implantation, Myopia Progression
- What is being tested?
- Atropine Eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children after IOL implantation (primary or secondary)
- Age 1-7 years
Who cannot join
- Eyes with post-operative media opacity hindering adequate assessment of refraction
- Eyes with complicated surgeries (e.g. vitreous loss, dropped lens matter requiring PPV, retinal detachment, etc)
- Retinal pathologies
- Glaucoma (congenital or secondary to surgery)
- Anterior or posterior segment anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, 11965
Rawan Hosny, MSc, +201005556839, rawan.m.hosny@students.kasralainy.edu.eg
About this study
Official title: Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery: A Randomized Clinical Trial
Myopic shift remains a debilitating and unpredictable adverse event following pediatric cataract surgery. While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, 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.
The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.
Read the detailed description
Cataract is a leading cause of visual impairment in the pediatric age group, with an annual incidence of 1.8 to 3.6 per 10,000. 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 challenge.
Normal ocular growth is characterized by axial length elongation along with corneal and lenticular flattening with a net refractive shift of approximately -0.9D. Cataract surgery in infants interrupts normal emmetropization of eyes and can lead to large myopic shift which may reach over 10 D.
Myopia is an epidemic with an estimated increase in prevalence to 50% by 2025. Rapidly progressing myopia significantly increases risk of permanent visual loss due to several ocular complications as maculopathy, retinal detachment and glaucoma.
Strategies for myopia control and prevention involve both optical and pharmacological measures, with atropine being a cornerstone in myopia management. 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 pathway. 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 eye. Another plausible mechanism is that up- and down-regulation of scleral muscarinic receptors influences scleral matrix deposition. 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 response.
While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, the use of multifocal 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.
The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.
- Conditions
- Pediatric Cataract, IOL Implantation, Myopia Progression
- Being tested
- Atropine Eye drops
- Keywords
- pediatric cataract, iol, iol implantation, myopia
- Medical subject headings
- Intraocular Lymphoma, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine Eye dropsDrug
Atropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Atropine | Experimental | Children receiving atropine 0.05% eye drops following IOL implantation. (as intervention) Receives: Drug: Atropine Eye drops |
| Control | No intervention | Children receiving placebo eye drops following IOL implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spherical equivalent in diopters of each group.
Spherical equivalent will be determined using auto-refractometer and/or manual retinoscopy. It will be reported in diopters (D).
Measured: Over a period of 12 months
Change in axial length in millimeters in each group.
Axial length will be measured using A-scan or optical biometry and will be reported in millimeters (mm).
Measured: 12 months
Secondary outcomes (1)
Rate of side-effects of atropine 0.05% eye drop use.
Rate of side-effects of atropine 0.05 eye drops will be reported as mydriasis leading to photophobia, blurring, and local allergic responses.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CataractStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Awadein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364370
- Sponsor's protocol ID
- MD-433-2025
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available upon request to rawan.m.hosny@students.kasralainy.edu.eg with strict patient anonymity ensured.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07364370
- Acronym / sponsor ID
- MD-433-2025
- Conditions
- Pediatric Cataract, IOL Implantation, Myopia Progression
- Keywords
- pediatric cataract, iol, iol implantation, myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myopic shift remains a debilitating and unpredictable adverse event following pediatric cataract surgery. While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, 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.
The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.
Detailed description
Cataract is a leading cause of visual impairment in the pediatric age group, with an annual incidence of 1.8 to 3.6 per 10,000. 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 challenge.
Normal ocular growth is characterized by axial length elongation along with corneal and lenticular flattening with a net refractive shift of approximately -0.9D. Cataract surgery in infants interrupts normal emmetropization of eyes and can lead to large myopic shift which may reach over 10 D.
Myopia is an epidemic with an estimated increase in prevalence to 50% by 2025. Rapidly progressing myopia significantly increases risk of permanent visual loss due to several ocular complications as maculopathy, retinal detachment and glaucoma.
Strategies for myopia control and prevention involve both optical and pharmacological measures, with atropine being a cornerstone in myopia management. 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 pathway. 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 eye. Another plausible mechanism is that up- and down-regulation of scleral muscarinic receptors influences scleral matrix deposition. 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 response.
While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, the use of multifocal 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.
The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine | Experimental | Drug: Atropine Eye dropsChildren receiving atropine 0.05% eye drops following IOL implantation. (as intervention) |
| Control | No intervention | –Children receiving placebo eye drops following IOL implantation. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children after IOL implantation (primary or secondary)
- Age 1-7 years
Key exclusion criteria (5 listed)
- Eyes with post-operative media opacity hindering adequate assessment of refraction
- Eyes with complicated surgeries (e.g. vitreous loss, dropped lens matter requiring PPV, retinal detachment, etc)
- Retinal pathologies
- Glaucoma (congenital or secondary to surgery)
- Anterior or posterior segment anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine Eye dropsAtropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months. | Drug | Atropine |
Primary outcome
Change in spherical equivalent in diopters of each group.
Time frame: Over a period of 12 months
Spherical equivalent will be determined using auto-refractometer and/or manual retinoscopy. It will be reported in diopters (D).
Change in axial length in millimeters in each group.
Time frame: 12 months
Axial length will be measured using A-scan or optical biometry and will be reported in millimeters (mm).
1 secondary outcome
Rate of side-effects of atropine 0.05% eye drop use.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available upon request to rawan.m.hosny@students.kasralainy.edu.eg with strict patient anonymity ensured.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atropine Eye drops in people with Pediatric Cataract and IOL Implantation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rawan Hosny, MSc (+201005556839, rawan.m.hosny@students.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spherical equivalent in diopters of each group. (time frame: Over a period of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.