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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02807935
• Other study ID #: SHEBA-16-2797-OZ-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 22, 2016
• Start date: July 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2016
• Source: Sheba Medical Center
• Contact: Meira Fogel-Levin, M.D
• Phone: 972-523249402
• Email: mirifoglevin[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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) . 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Device:
• Optical coherence tomography imaging

Locations

Country	Name	City	State
Israel	SHEBA medical center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean SC (schlemm's canal) cross-sectional area and volume		1 year	No
Secondary	Correlation of changes with intraocular pressure (IOP) reduction		1 year	No