NCT03605823

Brief Summary

Implantation of Ex-Press Minishunt via the pars plana in treatment of secondary glaucoma in vitrectomized eyes achieves promising results avoiding complications of other surgical modalities.

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2017

Typical duration for phase_1

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

Study Start

First participant enrolled

November 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

July 23, 2018

Last Update Submit

April 18, 2019

Conditions

Glaucoma Secondary

Keywords

Express Mini shunt; Pars plana; Vitrectomized eye

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure control (IOP)

    IOP less than 18 mmHg

    6 month

Interventions

Express Mini shuntDEVICE

Implantation of Express Mini shunt through pars plana in vitrectomized eyes

Eligibility Criteria

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

You may qualify if:

  • Secondary Glaucoma after vitrectomy not responding to maximum medical treatment

You may not qualify if:

  • Phakic eyes
  • Siliconized eyes
  • History of Uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11956, Egypt

RECRUITING

Central Study Contacts

Abdussalam M Abdullatif, MD

CONTACT

201117039868abdussalamabdullatif@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 30, 2018

Study Start

November 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)