GlaucomaNCT02807935
The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure
A study testing Optical coherence tomography imaging in people with Glaucoma and Cataract, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Optical coherence tomography imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to May 2018
- 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
- Male or female of any race, at least 18 years of age.
- Has provided verbal and written informed consent.
- Able and willing to follow instructions, including participation in all study assessments and visits.
- Has been referred to one of the treatments mentioned
Who cannot join
- Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
- Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
- any ocular or systemic conditions that may reduce OCT image quality (e.g., severe dry eye syndrome, visually significant cataract, limbal opacities, nystagmus, Parkinsonism, etc),
- Pregnant women or male or female younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
Israel1 site
SHEBA medical center
Ramat Gan
miri fogel levin, m.d, mirifoglevin@gmail.com
About this study
Official title: The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal
The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images will be taken as part of the patients routine medical follow up (before starting the treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be measured using commercially available 3-dimensional reconstruction.
The series of studies will be divided into 3 branches, each branch contains different treatments.For each treatment different patients will be recruited.
Read more
The branches are as following-
- The surgical branch-
- Before and after trabeculotomy
- Before and after cataract surgery
- Before and after vitrectomy surgery
- Before and after XEN™ Gel Stent implant
- The pharmacological branch-
- Before and during the treatment with prostaglandins analogs
- Before and during the treatment with alpha blockers
- Before and during the treatment with beta blockers
- Before and during the treatment with carbonic anhydrase inhibitor
- The laser branch-
- Before and after trabeculoplasty
- Before and after laser iridotomy
- Before and after yag capsulotomy laser
- Being tested
- Optical coherence tomography imaging
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| OCT imaging of surgical/pharmacological/laser branch | Other | to evaluate the effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy in the surgical branch:
1. Before and after trabeculotomy
2. Before and after cataract surgery
3. Before and after vitrectomy surgery
4. Before and after XEN™ Gel Stent implant
pharmacological branch-
1. Before and during the treatment with prostaglandins analogs
2. Before and during the treatment with alpha blockers
3. Before and during the treatment with beta blockers
4. Before and during the treatment with carbonic anhydrase inhibitor
laser branch-
1. Before and after trabeculoplasty
2. Before and after laser iridotomy
3. Before and after yag capsulotomy laser Receives: Device: Optical coherence tomography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SC (schlemm's canal) cross-sectional area and volume
Measured: 1 year
Secondary outcomes (1)
Correlation of changes with intraocular pressure (IOP) reduction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807935
- Sponsor's protocol ID
- SHEBA-16-2797-OZ-CTIL
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal
- ClinicalTrials.gov ID
- NCT02807935
- Acronym / sponsor ID
- SHEBA-16-2797-OZ-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 21 Jun 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.
The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images will be taken as part of the patients routine medical follow up (before starting the treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be measured using commercially available 3-dimensional reconstruction.
The series of studies will be divided into 3 branches, each branch contains different treatments.For each treatment different patients will be recruited.
The branches are as following-
- The surgical branch-
- Before and after trabeculotomy
- Before and after cataract surgery
- Before and after vitrectomy surgery
- Before and after XEN™ Gel Stent implant
- The pharmacological branch-
- Before and during the treatment with prostaglandins analogs
- Before and during the treatment with alpha blockers
- Before and during the treatment with beta blockers
- Before and during the treatment with carbonic anhydrase inhibitor
- The laser branch-
- Before and after trabeculoplasty
- Before and after laser iridotomy
- Before and after yag capsulotomy laser
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT imaging of surgical/pharmacological/laser branch | Other | Device: Optical coherence tomography imagingto evaluate the effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy in the surgical branch: 1. Before and after trabeculotomy 2. Before and after cataract surgery 3. Before and after vitrectomy surgery 4. Before and after XEN™ Gel Stent implant pharmacological branch- 1. Before and during the treatment with prostaglandins analogs 2. Before and during the treatment with alpha blockers 3. Before and during the treatment with beta blockers 4. Before and during the treatment with carbonic anhydrase inhibitor laser branch- 1. Before and after trabeculoplasty 2. Before and after laser iridotomy 3. Before and after yag capsulotomy laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of any race, at least 18 years of age.
- Has provided verbal and written informed consent.
- Able and willing to follow instructions, including participation in all study assessments and visits.
- Has been referred to one of the treatments mentioned
Key exclusion criteria (4 listed)
- Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
- Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
- any ocular or systemic conditions that may reduce OCT image quality (e.g., severe dry eye syndrome, visually significant cataract, limbal opacities, nystagmus, Parkinsonism, etc),
- Pregnant women or male or female younger than 18 years of age
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 |
|---|---|---|
| Optical coherence tomography imaging | Device | OCT imaging of surgical/pharmacological/laser branch |
Primary outcome
Mean SC (schlemm's canal) cross-sectional area and volume
Time frame: 1 year
1 secondary outcome
Correlation of changes with intraocular pressure (IOP) reduction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography imaging in people with Glaucoma and Cataract, 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 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: status not confirmed, as of the sponsor's last update on 23 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meira Fogel-Levin, M.D (972-523249402, mirifoglevin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean SC (schlemm's canal) cross-sectional area and volume (time frame: 1 year). 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 23 Jun 2016.