NCT04648943

Brief Summary

This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Status
completed

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

July 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

November 21, 2020

Last Update Submit

November 24, 2020

Conditions

Glaucoma Eye

Keywords

glaucomatrabeculectomyEx-PRESS glaucoma drainage implantcorneal hysteresiscorneal resistance factor

Outcome Measures

Primary Outcomes (1)

  • Change of corneal biomechanical properties

    Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH). These two indicators were measured before surgery and at 1, 6 and 12 months after surgery

    12 months

Secondary Outcomes (1)

  • Change of Intraocular Pressure

    12 months

Study Arms (2)

Patients undergoing Ex-Press mini shunt insertion

ACTIVE COMPARATOR

Patients in this arm had the Ex-Press mini shunt inserted in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer

Procedure: Ex-Press mini shunt insertion

Patients undergoing trabeculectomy

ACTIVE COMPARATOR

Patients in this arm had standard trabeculectomy in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer

Procedure: Trabeculectomy

Interventions

Ex-Press mini shunt insertionPROCEDURE
Patients undergoing Ex-Press mini shunt insertion
TrabeculectomyPROCEDURE
Patients undergoing trabeculectomy

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Average Intraocular pressure \> 24 mmHg on at least 2 occasions 1 month before surgery
  • Congenital glaucoma

You may not qualify if:

  • Previous ocular trauma
  • Previous ocular surgery other than phacoemulsification
  • Previous disease of the ocular surface

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Georgios Labiris, MD, PhD

    Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Associate) of Democritus University of Thrace

Study Record Dates

First Submitted

November 21, 2020

First Posted

December 2, 2020

Study Start

July 1, 2013

Primary Completion

May 31, 2016

Study Completion

November 30, 2016

Last Updated

December 2, 2020

Record last verified: 2020-11