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NCT02459600 Clinical Trial

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

General Anesthesia Clinical Trial

Official title:
Methodes of Meausring Refraction in Children Under General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02459600
Other study ID # SOR026014CTIL
Secondary ID
Status Recruiting
Phase Phase 0
First received May 5, 2015
Last updated June 1, 2015
Start date May 2015
Est. completion date May 2016

Study information
Verified date May 2015
Source Soroka University Medical Center
Contact Zvi Gur, MD
Phone 972-54-9496356
Email ZVIGUR@HOTMAIL.COM
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria:

1. 1 - 12 years old

2. Eyes that didn't underwent surgical procedure

Exclusion Criteria:

1. eye operation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• instulling cyclopentolate drops in the eye
measuring refraction with and wirthout cyclopentolate drops under general anesthesia

Locations
Country Name City State
Israel Soroka Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary difference in refraction results with and without cyclopentolate drops under general anesthesia 12 months No
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