NCT02459600

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

May 5, 2015

Last Update Submit

June 1, 2015

Conditions

General Anesthesia

Keywords

Eye surgeryChildren

Outcome Measures

Primary Outcomes (1)

  • difference in refraction results with and without cyclopentolate drops under general anesthesia

    12 months

Study Arms (1)

All participants

EXPERIMENTAL

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

Interventions

instulling cyclopentolate drops in the eyeOTHER

measuring refraction with and wirthout cyclopentolate drops under general anesthesia

All participants

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • Eyes that didn't underwent surgical procedure

You may not qualify if:

  • \. eye operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka

Beersheba, Israel

RECRUITING

Study Officials

  • Zvi Gur, MD

    Soroka University Medial Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zvi Gur, MD

CONTACT

972-54-9496356ZVIGUR@HOTMAIL.COM

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zvi Gur, MD

Study Record Dates

First Submitted

May 5, 2015

First Posted

June 2, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations

IL(1)