Healthy VolunteersNCT02023073
Determination of Physical Parameters Relevant to Ophthalmic Lasers
An observational study of Healthy Volunteers, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in particular, increased significantly. Making retinal surgery using lasers have become increasingly common. The goal: to diagnose eye diseases safely Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 31 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Age 18-40 years
- Refraction up to ±0.25D,
- General good health
- Written informed consent to participate in the study.
Who cannot join
- known current ophthalmic pathology
- known past ophthalmic pathology (including LASIK surgery)
- eye glasses or contact lenses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Goldschleger Eye Research Institute, Sheba Medical Center,
Tel HaShomer, 52621
Ygal Rotenstreich, MD, 972-3-530-2880, ygal.rotenstreich@sheba.health.gov.il
About this study
Official title: Study of Physical Parameters Related to Laser Radiation and Its Interaction With Different Parts of the Human Eye
The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in particular, increased significantly. Making retinal surgery using lasers have become increasingly common. The goal: to diagnose eye diseases safely
- Conditions
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflected laser radiation (Watt/cm 2)
The amplitude of laser radiation reflected from the eye at different wavelengths (532nm, 800nm \& 900nm) at 4 angles (-10, 05, 0 and 10 degrees ) will be measured (Watt/cm 2)
Measured: 1 day
Secondary outcomes (2)
Reflection of laser radiation from the cornea (Watt/cm2)
Measured: 1 day
Reflection of laser radiation from the retina (Watt/cm 2)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start1 Jul 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
- Investigators
- Ygal Rotenstreich, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023073
- Sponsor's protocol ID
- SHEBA-13-9977-YR-CTIL
- Status last verified
- Sep 2025
- First submitted
- 17 Dec 2013
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Physical Parameters Related to Laser Radiation and Its Interaction With Different Parts of the Human Eye
- ClinicalTrials.gov ID
- NCT02023073
- Acronym / sponsor ID
- SHEBA-13-9977-YR-CTIL
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Dec 2013 (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.
The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in particular, increased significantly. Making retinal surgery using lasers have become increasingly common. The goal: to diagnose eye diseases safely
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Age 18-40 years
- Refraction up to ±0.25D,
- General good health
- Written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- known current ophthalmic pathology
- known past ophthalmic pathology (including LASIK surgery)
- eye glasses or contact lenses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reflected laser radiation (Watt/cm 2)
Time frame: 1 day
The amplitude of laser radiation reflected from the eye at different wavelengths (532nm, 800nm \& 900nm) at 4 angles (-10, 05, 0 and 10 degrees ) will be measured (Watt/cm 2)
2 secondary outcomes
Reflection of laser radiation from the cornea (Watt/cm2)
Time frame: 1 day
Reflection of laser radiation from the retina (Watt/cm 2)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Screening Protocol
Pain
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.
Ygal Rotenstreich, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Sheba 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ygal Rotenstreich, MD (972-3-5302880, ygal.rotenstreich@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflected laser radiation (Watt/cm 2) (time frame: 1 day). 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 6 Oct 2025.