Comparison of Refraction Measurments in Children Under General Anesthesia, With and Without Cycloplegic Drops

Early Phase 1

• Conditions: General Anesthesia
• Interventions: Other: instulling cyclopentolate drops in the eye

• Registration Number: NCT02459600
• Lead Sponsor: Soroka University Medical Center

Brief Summary

Assessment of refraction measurements in children under general anesthesia, with or without cyclopelgic eye-drops

Detailed Description

Comparing to adults, children have high ability to preform accommodation of the intraocular lens, that is due to the Ciliary muscle. In order to measure children's refraction in an accurate way the Ciliary muscle must be paralyzed and that is usually done be cycloplegic eye-drops .In case a child is undergoing a medical procedure under general anesthesia the assumption that the Ciliary muscle is paralyzed (complete or partially) due to anesthetic medications. In this study we would like to compare the refraction measurements in children under who undergo general anesthesia before and after applying cycloplegic eye-drops. In this way we can learn about the effect of anesthetic medication on the Ciliary muscle.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-06-01
• Last Update Submitted: 2015-06-01
• Study First Posted: 2015-06-02
• Last Update Posted: 2015-06-02
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 1 - 12 years old
2. Eyes that didn't underwent surgical procedure

Exclusion Criteria

1. eye operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	instulling cyclopentolate drops in the eye	The measurement will be done at all the participants. the results will the divides in the following way: 1. Refraction measurements under general anesthesia without cycloplegic eye drops. 2. Refraction measurements under general anesthesia with cycloplegic eye drops.

Primary Outcome Measures

Name	Time	Method
difference in refraction results with and without cyclopentolate drops under general anesthesia	12 months

Trial Locations

Locations (1)

Soroka; 🇮🇱 Beer Sheva, Israel