Testing microdrops of cyclopentolate for eye exams in children
Efficacy and Safety of Cyclopentolate Microdrops for Cycloplegic Refraction in Children: a Non-inferiority Crossover Randomized Controlled Trial
This study is testing if tiny drops of a medication for eye exams work just as well and are safe for children compared to regular-sized drops.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT06885242 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of microdrop instillation of cyclopentolate 1% compared to the standard drop method for cycloplegic refraction in children. It is a non-inferiority, crossover, randomized controlled trial where participants will receive either microdrops or standard drops in a randomized order. The study will assess the effectiveness of microdrops in achieving adequate cycloplegia and monitor any adverse events associated with both methods. Written informed consent will be obtained from parents or guardians for their children's participation.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-16 years who need cycloplegic refraction measurements during routine ophthalmological examinations.
Not a fit: Patients who cannot cooperate with the autorefractometer or have known allergies to cyclopentolate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less invasive method for conducting eye exams in children.
How similar studies have performed: Other studies have shown promising results with similar microdrop approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Inability for the child to cooperate with autorefractometer 2. Difficulties for the family to attend the follow-up visit 3. Known allergic reaction to cyclopentolate or to any of the other ingredients of this solution 4. Presence of any contraindication for the child to receive cyclopentolate eyedrops (e.g. neurological disease of concern)
Where this trial is running
Thessaloniki
- Papageorgiou General Hospital — Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Asimina Mataftsi, MD, PhD, MRCOphth
- Email: amatafts@auth.gr
- Phone: +30 6985 071555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.