Retinal DetachmentNCT02715388
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
A study testing GlasScope Surgical Microscope in people with Retinal Detachment, run by Elbit Systems LTD at 1 site in Israel.
Trial summary
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- GlasScope Surgical Microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Mar 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18.
- Pseudophakia patients with silicone oil in the vitreous cavity.
- Silicone oil density of 1500 centistoke or 5500 CS.
- Good corrected visual acuity (> 6/10) in the second eye.
- Lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
Who cannot join
- Additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
- The presence of heavy silicone oil (OXANE) in the vitreous cavity.
- Posterior segment pathology in the second eye.
- Special populations (children under the age of 18, pregnant women)
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.
- Conditions
- Retinal Detachment
- Being tested
- GlasScope Surgical Microscope
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlasScope Surgical MicroscopeDevice
3D visualization of the poterior chamber for silicon oil removal
| Study group | Role | What they receive |
|---|---|---|
| Silicon oil removal 3D visualization | Experimental | Not described Receives: Device: GlasScope Surgical Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Field of view of GlasScope surgical microscope
Measured: Up to 3 days after surgery
Depth of field of GlasScope surgical microscope
Measured: Up to 3 days after surgery
3D perception of GlasScope surgical microscope
3D perception of GlasScope surgical microscope is assessed by the surgeon ability to perform surgical gentle procedures using the surgical tools on the eye tissues - both inner and posterior parts of the eye.
Measured: Up to 3 days after surgery
Secondary outcomes (1)
Surgeon fatigue and neck strain (questionnaire)
Questioning the surgeons after surgery on the pain and stress during the use of Glasscope causing decreased performance/lack of concentration/fatigue, the complexity on keeping the eye-piece image in the surgeon sight, how the instrument prevents the surgeon situation awareness in the operating room, the stress and fatigue on the surgeon eyes for long duration of observation in the image
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elbit Systems LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adiel Barak, Prof, Principal investigator, Head of Retina Department, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715388
- Sponsor's protocol ID
- 0389-15-TLV
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2016
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
- ClinicalTrials.gov ID
- NCT02715388
- Acronym / sponsor ID
- 0389-15-TLV
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Elbit Systems LTDIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jan 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 22 Mar 2016 (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.
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silicon oil removal 3D visualization | Experimental | Device: GlasScope Surgical Microscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18.
- Pseudophakia patients with silicone oil in the vitreous cavity.
- Silicone oil density of 1500 centistoke or 5500 CS.
- Good corrected visual acuity (> 6/10) in the second eye.
- Lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
Key exclusion criteria (4 listed)
- Additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
- The presence of heavy silicone oil (OXANE) in the vitreous cavity.
- Posterior segment pathology in the second eye.
- Special populations (children under the age of 18, pregnant women)
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 |
|---|---|---|
| GlasScope Surgical Microscope3D visualization of the poterior chamber for silicon oil removal | Device | Silicon oil removal 3D visualization |
Primary outcome
Field of view of GlasScope surgical microscope
Time frame: Up to 3 days after surgery
Depth of field of GlasScope surgical microscope
Time frame: Up to 3 days after surgery
3D perception of GlasScope surgical microscope
Time frame: Up to 3 days after surgery
3D perception of GlasScope surgical microscope is assessed by the surgeon ability to perform surgical gentle procedures using the surgical tools on the eye tissues - both inner and posterior parts of the eye.
1 secondary outcome
Surgeon fatigue and neck strain (questionnaire)
Time frame: Up to 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Adiel Barak, Prof principal investigator
Head of Retina Department, Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlasScope Surgical Microscope in people with Retinal Detachment, run by Elbit Systems LTD 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 28 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Field of view of GlasScope surgical microscope (time frame: Up to 3 days after surgery). The study lists 3 primary outcomes in all. 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 28 Apr 2022.