NCT02807935

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. 1.The surgical branch-
  2. 2.Before and after trabeculotomy
  3. 3.Before and after cataract surgery
  4. 4.Before and after vitrectomy surgery
  5. 5.Before and after XEN™ Gel Stent implant
  6. 6.The pharmacological branch-
  7. 7.Before and during the treatment with prostaglandins analogs
  8. 8.Before and during the treatment with alpha blockers
  9. 9.Before and during the treatment with beta blockers
  10. 10.Before and during the treatment with carbonic anhydrase inhibitor
  11. 11.The laser branch-
  12. 12.Before and after trabeculoplasty
  13. 13.Before and after laser iridotomy
  14. 14.Before and after yag capsulotomy laser

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

June 17, 2016

Last Update Submit

June 22, 2016

Conditions

GlaucomaCataract

Outcome Measures

Primary Outcomes (1)

  • Mean SC (schlemm's canal) cross-sectional area and volume

    1 year

Secondary Outcomes (1)

  • Correlation of changes with intraocular pressure (IOP) reduction

    1 year

Study Arms (1)

OCT imaging of surgical/pharmacological/laser branch

OTHER

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

Interventions

Optical coherence tomography imagingDEVICE
OCT imaging of surgical/pharmacological/laser branch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female of any race, at least 18 years of age.
  • Has provided verbal and written informed consent.
  • Able and willing to follow instructions, including participation in all study assessments and visits.
  • Has been referred to one of the treatments mentioned

You may not qualify if:

  • Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
  • Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
  • 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),
  • Pregnant women or male or female younger than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SHEBA medical center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

GlaucomaCataract

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Central Study Contacts

Meira Fogel-Levin, M.D

CONTACT

972-523249402mirifoglevin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

IL(1)