NCT02209961

Brief Summary

A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

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

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

March 19, 2014

Last Update Submit

August 5, 2014

Conditions

Glaucoma and Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .

    to check the change in intraocular pressure after EX-PRESS shunt implantation

    within one to two years post surgery

Study Arms (1)

glaucoma and ocular hypertension

glaucoma and ocular hypertension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with uncontrolled glaucoma

You may qualify if:

  • \- age above 18

You may not qualify if:

  • \- congenital glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Rana N Hanna, M.D

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

August 6, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

August 6, 2014

Record last verified: 2014-08