Drug effects on blood pressure, heart rate, and eyes in children with refractive error
- Conditions
- Refractive errorEye DiseasesDisorder of refraction, unspecified
- Registration Number
- ISRCTN17363525
- Lead Sponsor
- Research Unit of Cicendo National Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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