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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02807935

Enrollment

440

Registered

2016-06-21

Start date

2016-07-31

Completion date

2018-05-31

Last updated

2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Cataract

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

Interventions

DEVICEOptical coherence tomography imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactMeira Fogel-Levin, M.D

mirifoglevin@gmail.com972-523249402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026