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

NCT ID: NCT02459600

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

instulling cyclopentolate drops in the eye

Intervention Type OTHER

measuring refraction with and wirthout cyclopentolate drops under general anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

instulling cyclopentolate drops in the eye

measuring refraction with and wirthout cyclopentolate drops under general anesthesia

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1\. eye operation
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zvi Gur MD

Zvi Gur, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zvi Gur, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medial Center, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Soroka

Beersheba, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zvi Gur, MD

Role: CONTACT

972-54-9496356

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zvi Gur, MD

Role: primary

972549496356

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOR026014CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IOP Changes Associated With SICS and Phako
NCT02642211 COMPLETED EARLY_PHASE1