Cycloplegic RefractionPhase 4NCT06885242
Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children
A Phase 4 study testing Microdrop instillation of cyclopentolate 1% and Standard drop instillation of cyclopentolate 1% in people with Cycloplegic Refraction, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose is to test the hypothesis that microdrop instillation of cyclopentolate 1% is non-inferior to standard of care, i.e., standard drop instillation of cyclopentolate 1%. Comparison, also, will be made to the subsequent adverse events. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cycloplegic Refraction
- What is being tested?
- Microdrop instillation of cyclopentolate 1% and Standard drop instillation of cyclopentolate 1%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteGreece
- Study dates
- 6 Sep 2024to 8 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-16 years old, who require cycloplegic refraction measurements in the context of regular ophthalmological examination as outpatients in the 2nd Department of Ophthalmology of AUTh at a tertiary center in Northern Greece.
Who cannot join
- Inability for the child to cooperate with autorefractometer
- Difficulties for the family to attend the follow-up visit
- Known allergic reaction to cyclopentolate or to any of the other ingredients of this solution
- Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children: a Non-inferiority Crossover Randomized Controlled Trial
The purpose is to test the hypothesis that microdrop instillation of cyclopentolate 1% is non-inferior to standard of care, i.e., standard drop instillation of cyclopentolate 1%. Comparison, also, will be made to the subsequent adverse events.
Read the detailed description
A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops will be instilled using the Nanodropper® device, while standard drops will be instilled directly through the commercially available plastic multidose mydriatic dropper bottle. For all participants, the eyedrop will be firstly instilled in the right eye and this will be the eye that will be used for the analyses. Written informed consent will be obtained from the parents/guardians for the children's enrollment.
- Conditions
- Cycloplegic Refraction
- Being tested
- Microdrop instillation of cyclopentolate 1%, Standard drop instillation of cyclopentolate 1%
- Keywords
- microdrops, cycloplegia, refraction, cyclopentolate, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdrop instillation of cyclopentolate 1%Device
1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle
Standard drop instillation of cyclopentolate 1%Device
1 drop administered directly through the commercially available multi-dose dropper bottle
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Cycloplegia with microdrops Receives: Device: Microdrop instillation of cyclopentolate 1% |
| Control Group | Active comparator | Cycloplegia with standard drops Receives: Device: Standard drop instillation of cyclopentolate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic refraction: diopters of spherical equivalent
The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy)
Measured: 40 minutes post-instillation
Secondary outcomes (4)
Heart rate: bpm
The difference in heart rate after microdrop and standard drop instillation (safety outcome)
Measured: 40 minutes post-instillation
Flushing: absent, minor, major
The difference in the number of patients who experience flushing after microdrop and after standard drop instillation (safety outcome)
Measured: 40 minutes post-instillation
Behavioral changes: yes or no
The difference in the number of patients who experience behavioral changes after microdrop and after standard drop instillation (safety outcome)
Measured: 40 minutes post-instillation
Sleepiness: yes or no
The difference in the number of patients who experience sleepiness after microdrop and standard drop instillation (safety outcome)
Measured: 40 minutes post-instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start6 Sep 2024
- Primary completion26 Sep 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cycloplegic RefractionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Nanodropper, Inc.
- Responsible party
- Principal investigator, Asimina Mataftsi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885242
- Sponsor's protocol ID
- 383/19-06-2024
- Status last verified
- Nov 2025
- First submitted
- 14 Mar 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Seliniotaki AK, Tziola T, Lithoxopoulou M, Tzamalis A, Ziakas N, Mataftsi A. Optimizing instilled drug delivery: a scoping review of microdrops in ophthalmology. Graefes Arch Clin Exp Ophthalmol. 2025 Jul;263(7):1765-1787. doi: 10.1007/s00417-025-06773-1. Epub 2025 Feb 26.
PubMed 40011238Hoppe CB, Yonamine S, Kao BW, Turner ML, Ou Y, Han Y, Keenan JD, Oatts JT. Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children. Ophthalmology. 2023 Mar;130(3):324-330. doi: 10.1016/j.ophtha.2022.10.016. Epub 2022 Oct 22.
PubMed 36280185Noske W. Cycloplegic refraction using atropine minidrops. Strabismus. 1993;1(1):17-23. doi: 10.3109/09273979309033849.
PubMed 21314515
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children: a Non-inferiority Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06885242
- Acronym / sponsor ID
- 383/19-06-2024
- Conditions
- Cycloplegic Refraction
- Keywords
- microdrops, cycloplegia, refraction, cyclopentolate, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Nanodropper, Inc.
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 20 Mar 2025 (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.
The purpose is to test the hypothesis that microdrop instillation of cyclopentolate 1% is non-inferior to standard of care, i.e., standard drop instillation of cyclopentolate 1%. Comparison, also, will be made to the subsequent adverse events.
Detailed description
A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops will be instilled using the Nanodropper® device, while standard drops will be instilled directly through the commercially available plastic multidose mydriatic dropper bottle. For all participants, the eyedrop will be firstly instilled in the right eye and this will be the eye that will be used for the analyses. Written informed consent will be obtained from the parents/guardians for the children's enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Microdrop instillation of cyclopentolate 1%Cycloplegia with microdrops |
| Control Group | Active comparator | Device: Standard drop instillation of cyclopentolate 1%Cycloplegia with standard drops |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 4-16 years old, who require cycloplegic refraction measurements in the context of regular ophthalmological examination as outpatients in the 2nd Department of Ophthalmology of AUTh at a tertiary center in Northern Greece.
Key exclusion criteria (4 listed)
- Inability for the child to cooperate with autorefractometer
- Difficulties for the family to attend the follow-up visit
- Known allergic reaction to cyclopentolate or to any of the other ingredients of this solution
- Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)
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 |
|---|---|---|
| Microdrop instillation of cyclopentolate 1%1 drop administered through the Nanodropper device adapted to the commercially available multi-dose dropper bottle | Device | Study Group |
| Standard drop instillation of cyclopentolate 1%1 drop administered directly through the commercially available multi-dose dropper bottle | Device | Control Group |
Primary outcome
Cycloplegic refraction: diopters of spherical equivalent
Time frame: 40 minutes post-instillation
The difference in spherical equivalent (SE) after microdrop and standard drop instillation (cycloplegic efficacy)
4 secondary outcomes
Heart rate: bpm
Time frame: 40 minutes post-instillation
Flushing: absent, minor, major
Time frame: 40 minutes post-instillation
Behavioral changes: yes or no
Time frame: 40 minutes post-instillation
Sleepiness: yes or no
Time frame: 40 minutes post-instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Background: PubMed 40011238Seliniotaki AK, Tziola T, Lithoxopoulou M, Tzamalis A, Ziakas N, Mataftsi A. Optimizing instilled drug delivery: a scoping review of microdrops in ophthalmology. Graefes Arch Clin Exp Ophthalmol. 2025 Jul;263(7):1765-1787. doi: 10.1007/s00417-025-06773-1. Epub 2025 Feb 26.
- Background: PubMed 36280185Hoppe CB, Yonamine S, Kao BW, Turner ML, Ou Y, Han Y, Keenan JD, Oatts JT. Randomized Trial to Evaluate the Efficacy of the Nanodropper Device for Pupillary Dilation and Cycloplegia in Children. Ophthalmology. 2023 Mar;130(3):324-330. doi: 10.1016/j.ophtha.2022.10.016. Epub 2022 Oct 22.
- Background: PubMed 21314515Noske W. Cycloplegic refraction using atropine minidrops. Strabismus. 1993;1(1):17-23. doi: 10.3109/09273979309033849.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microdrop instillation of cyclopentolate 1% and Standard drop instillation of cyclopentolate 1% in people with Cycloplegic Refraction, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Nov 2025. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic refraction: diopters of spherical equivalent (time frame: 40 minutes post-instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885242, which also lists 3 linked publications.
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 4 Nov 2025.