Refractive error Eye Diseases Disorder of refraction, unspecified
Conditions
Interventions
This study is a single-blind randomized clinical trial with a parallel design to compare the ocular effects (changes in refractive power and size of pupillary dilatation) and systemic effects (changes
Sponsors
Research Unit of Cicendo National Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children 6-18 years of age who had mild to moderate refractive errors before administration of cycloplegic agents (myopia <6.00 D, hyperopia <3.00 D, and astigmatism <3.00 D)
Exclusion criteria
Exclusion criteria: 1. Visual disturbances unrelated to refractive errors, such as corneal opacities, uveitis, glaucoma, cataracts, posterior segment disorders, and disorders of the optic nerve/visual pathway 2. History of ocular surgery 3. Pupillary abnormalities or other neurological disorders 4. History of cardiovascular disease 5. Receiving systemic or ocular medical therapy that affects pupil function and/or accommodation 6. High anisometropia (difference in eye refractive status =2.00 D) 7. Strabismus, amblyopia 8. Light colored iris (green or blue iris) 9. Albinism 10. History of allergy to the components of the research drug 11. Children who were not cooperative during drug administration, did not complete autorefractometer and pupil diameter measurements, or developed adverse drug reactions after administration of the regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refractive power measured using autorefractometry and IOLMaster®700 examination in both eyes at 60 minutes after administration of the first drops of the combination drug regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure and heart rate measured using Omron Automatic Blood Pressure HEM 7120 at 60 minutes after administration of the first drops of a combination drug regimen | — |
Countries
Indonesia
Outcome results
None listed