search
Back to results

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

Primary Purpose

Glaucoma, Cataract

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Optical coherence tomography imaging
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female of any race, at least 18 years of age.
  2. Has provided verbal and written informed consent.
  3. Able and willing to follow instructions, including participation in all study assessments and visits.
  4. Has been referred to one of the treatments mentioned

Exclusion Criteria:

  1. Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
  2. Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
  3. 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),
  4. Pregnant women or male or female younger than 18 years of age

Sites / Locations

  • SHEBA medical center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OCT imaging of surgical/pharmacological/laser branch

Arm Description

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

Outcomes

Primary Outcome Measures

Mean SC (schlemm's canal) cross-sectional area and volume

Secondary Outcome Measures

Correlation of changes with intraocular pressure (IOP) reduction

Full Information

First Posted
June 17, 2016
Last Updated
June 22, 2016
Sponsor
Sheba Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02807935
Brief Title
The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure
Official Title
The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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- 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCT imaging of surgical/pharmacological/laser branch
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optical coherence tomography imaging
Primary Outcome Measure Information:
Title
Mean SC (schlemm's canal) cross-sectional area and volume
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation of changes with intraocular pressure (IOP) reduction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meira Fogel-Levin, M.D
Phone
972-523249402
Email
mirifoglevin@gmail.com
Facility Information:
Facility Name
SHEBA medical center
City
Ramat-Gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
miri fogel levin, m.d
Email
mirifoglevin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs