General AnesthesiaEarly Phase 1NCT02459600
Comparison of Refraction Measurments in Children Under General Anesthesia, With and Without Cycloplegic Drops
A Early Phase 1 study testing instulling cyclopentolate drops in the eye in people with General Anesthesia, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Assessment of refraction measurements in children under general anesthesia, with or without cyclopelgic eye-drops Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- instulling cyclopentolate drops in the eye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to May 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 - 12 years old
- Eyes that didn't underwent surgical procedure
Who cannot join
- 1. eye operation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka
Beersheba
Zvi Gur, MD, 972549496356, ZVIGUR@HOTMAIL.COM
About this study
Official title: Methodes of Meausring Refraction in Children Under General Anesthesia
Assessment of refraction measurements in children under general anesthesia, with or without cyclopelgic eye-drops
Read the 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.
- Conditions
- General Anesthesia
- Being tested
- instulling cyclopentolate drops in the eye
- Keywords
- Eye surgery, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instulling cyclopentolate drops in the eyeOther
measuring refraction with and wirthout cyclopentolate drops under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: instulling cyclopentolate drops in the eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in refraction results with and without cyclopentolate drops under general anesthesia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zvi Gur MD, Soroka University Medical Center
- Investigators
- Zvi Gur, MD, Principal investigator, Soroka University Medial Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459600
- Sponsor's protocol ID
- SOR026014CTIL
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodes of Meausring Refraction in Children Under General Anesthesia
- ClinicalTrials.gov ID
- NCT02459600
- Acronym / sponsor ID
- SOR026014CTIL
- Conditions
- General Anesthesia
- Keywords
- Eye surgery, Children
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: instulling cyclopentolate drops in the eyeThe 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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1 - 12 years old
- Eyes that didn't underwent surgical procedure
Key exclusion criteria (1 listed)
- 1. eye operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instulling cyclopentolate drops in the eyemeasuring refraction with and wirthout cyclopentolate drops under general anesthesia | Other | All participants |
Primary outcome
difference in refraction results with and without cyclopentolate drops under general anesthesia
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zvi Gur, MD principal investigator
Soroka University Medial Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing instulling cyclopentolate drops in the eye in people with General Anesthesia, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Gur, MD (972-54-9496356, ZVIGUR@HOTMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in refraction results with and without cyclopentolate drops under general anesthesia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.