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

June 1, 2015 updated by: Zvi Gur MD, Soroka University Medical Center

Methodes of Meausring Refraction in Children Under General Anesthesia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. eye operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in refraction results with and without cyclopentolate drops under general anesthesia
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Zvi Gur, MD, Soroka University Medial Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR026014CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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