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

Not Applicable

• Conditions: Cataract; Glaucoma
• Interventions: Device: Optical coherence tomography imaging

• Registration Number: NCT02807935
• Lead Sponsor: Sheba Medical Center

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-

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23
• Study Start: 2016-07
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 440

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT imaging of surgical/pharmacological/laser branch	Optical coherence tomography imaging	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

Primary Outcome Measures

Name	Time	Method
Mean SC (schlemm's canal) cross-sectional area and volume	1 year

Secondary Outcome Measures

Name	Time	Method
Correlation of changes with intraocular pressure (IOP) reduction	1 year

Trial Locations

Locations (1)

SHEBA medical center; 🇮🇱 Ramat-Gan, Israel