The in Vivo Effect of Medical and Surgical Glaucoma Treat... | NCT02807935

Studies
The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure

NCT02807935

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 23, 2016Estimated

Enrollment

440Estimated

Phase

Not Applicable

Conditions

Glaucoma
Cataract

Interventions

Optical coherence tomography imaging

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Jun 17, 2016

First Submission Date that Met QC Criteria

Jun 20, 2016

First Posted Date

Jun 21, 2016Estimated

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

Jun 22, 2016

Last Update Posted Date

Jun 23, 2016Estimated

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 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-
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
The 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
The laser branch-
1. Before and after trabeculoplasty
2. Before and after laser iridotomy
3. Before and after yag capsulotomy laser

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

440Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Before and after trabeculotomy Before and after cataract surgery Before and after vitrectomy surgery Before and after XEN™ Gel Stent implant 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 laser branch- Before and after trabeculoplasty Before and after laser iridotomy Before and after yag capsulotomy laser	Device: Optical coherence tomography imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical coherence tomography imaging	Device		OCT imaging of surgical/pharmacological/laser branch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean SC (schlemm's canal) cross-sectional area and volume		1 year

Secondary Outcomes

Measure	Description	Time Frame
Correlation of changes with intraocular pressure (IOP) reduction		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meira Fogel-Levin, M.D	Contact	972-523249402		mirifoglevin@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SHEBA medical center		Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D002386	Cataract

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D007905	Lens Diseases

Browse Leaves

Not provided

Browse Branches

Not provided