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

June 22, 2016 updated by: Sheba Medical Center

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.

The branches are as following-

  1. 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

  2. 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

  3. The laser branch-

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: OCT imaging of surgical/pharmacological/laser branch

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
Device: Optical coherence tomography imaging

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-16-2797-OZ-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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