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Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Brown Irides: A Randomized
Wejdan Al-Thawabieh1, Rami Al-Omari2, Diala Walid Abu-Hassan3
1From the Department of Ophthalmology, Dr. Sulaiman Al-Habib Hospital (W.A.-T.), Riyadh, Saudi Arabia.
Insights
Tropicamide 1% and cyclopentolate 1% showed statistically significant differences in cycloplegic refraction for children, but the changes were clinically insignificant. Tropicamide may be a safe alternative for pediatric eye exams.
Area of Science:
- Ophthalmology
- Pediatric Optometry
- Clinical Trial Research
Background:
- Accurate refractive error assessment is crucial for pediatric eye care.
- Cycloplegic refraction is essential for determining true refractive error in children.
- Tropicamide and cyclopentolate are commonly used cycloplegic agents.
Purpose of the Study:
- To compare the efficacy of tropicamide 1% versus cyclopentolate 1% for cycloplegic refraction in children aged 3-16 years.
- To evaluate the clinical significance of refractive changes induced by these agents in pediatric patients.
Main Methods:
- A randomized, controlled, multicenter prospective clinical trial was conducted.
- Children aged 3-16 years with brown irides received either tropicamide 1% or cyclopentolate 1% in one visit.
- A second cycloplegic refraction was performed using the alternative agent after a minimum 1-week interval.
Main Results:
- A total of 185 eyes from 94 children were analyzed.
- Both tropicamide and cyclopentolate induced statistically significant changes in spherical equivalent (SE) (P < .001).
- The difference in mean change in SE (ΔSE) between cyclopentolate (1.15±1.2) and tropicamide (1.04±1.2) was statistically significant (P < .001) but clinically insignificant.
Conclusions:
- Tropicamide 1% demonstrated comparable cycloplegic efficacy to cyclopentolate 1% in children aged 3-16 years.
- Tropicamide may serve as an effective and safe alternative to cyclopentolate for routine cycloplegic refraction in nonstrabismic pediatric populations.
- Refractive changes were clinically insignificant across all refractive error groups.
Purpose:
To compare the final cycloplegic refraction of tropicamide 1% and cyclopentolate 1% in children 3-16 years of age with brown irides.
Design:
Randomized, controlled, multicenter prospective clinical trial.
Methods:
Included patients were randomized to either cyclopentolate 1% or tropicamide 1% in the first visit with autorefraction measurements. Each subject underwent a second cycloplegic refraction using the other agent on a separate visit with a minimum of 1-week interval and a maximum of 12 weeks. We measured the change in SE (ΔSE) for each eye by deducting the SE before cycloplegia from the SE after cycloplegia.
Results:
A total of 185 eyes from 94 children aged 3-16 years (average= 8.79 ±3.11 years) were included. The average SE of both eyes before cycloplegia was -0.082 ± 4.8 diopters. The SE after instillation of cyclopentolate and tropicamide in both eyes was 1.07±5.2 and 0.96±5.1, respectively (P value < .001). The average ΔSE after cycloplegia was 1.15±1.2 for cyclopentolate and 1.04±1.2 for tropicamide (P value < .001). The difference between ΔSE of cyclopentolate and tropicamide was found statistically significant at 0.11±1.2 (P < .001), although clinically insignificant. The ΔSE between the 2 drops before and after cycloplegia in both eyes for all refractive error groups was clinically insignificant. The greatest effect of cyclopentolate and tropicamide was in hyperopic eyes with ΔSE of 1.54±1.4 and 1.39±1.4, respectively.
Conclusions:
Tropicamide might be an effective and safe replacement for cyclopentolate in the refracting nonstrabismic pediatric population 3-16 years of age regardless of their refractive error status.
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