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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye

NCT02622191

Glaucoma

COMPLETED NA

EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA

NCT01384149

Primary Open Angle Glaucoma

COMPLETED PHASE1

Diagnostic Innovations in Glaucoma Study

NCT00221897

Primary Open Angle Glaucoma Myopia

RECRUITING

Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma

NCT05892185

Glaucoma

UNKNOWN NA

Advanced Glaucoma Progression Study

NCT01742819

Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma Chronic Angle Closure Glaucoma

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Optical coherence tomography imaging

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optical coherence tomography imaging

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes