Determination of Physical Parameters Relevant to Ophthalm... | NCT02023073

Studies
Determination of Physical Parameters Relevant to Ophthalmic Lasers

NCT02023073

Sponsor

Sheba Medical Center

Status

Recruiting

Last Update Posted

Oct 6, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Healthy Volunteers

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Dec 22, 2013

First Posted Date

Dec 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Ygal Rotenstreich, Director, Electrophysiology Clinic, Goldschleger Eye Research Institute, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	1 day

Secondary Outcomes

Measure	Description	Time Frame
Reflection of laser radiation from the cornea (Watt/cm2)		1 day
Reflection of laser radiation from the retina (Watt/cm 2)		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-40 years
Refraction up to ±0.25D,
General good health
Written informed consent to participate in the study.

Exclusion Criteria:

known current ophthalmic pathology
known past ophthalmic pathology (including LASIK surgery)
eye glasses or contact lenses

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ygal Rotenstreich, MD	Contact	972-3-5302880		ygal.rotenstreich@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Ygal Rotenstreich, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goldschleger Eye Research Institute, Sheba Medical Center,	Recruiting	Tel Litwinsky		52621	Israel