NCT00853905

Brief Summary

The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

February 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 21, 2016

Completed
Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

February 27, 2009

Results QC Date

February 12, 2015

Last Update Submit

June 11, 2018

Conditions

Glaucoma

Keywords

open angle glaucoma (POAG)angle closure glaucoma (PACG)pigmentary glaucomapseudoexfoliation glaucomaneovascular glaucomatraumatic glaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.

    1 day, 1week, 1 month, 3 month and 6 month post-op visits

Secondary Outcomes (4)

  • Anterior Chamber Inflammation (Flare)

    1 month, 3 month and 6 month post-op visits

  • Bleb Appearance

    1 day, 1 week, 1 month, 3 month and 6 month post-op visits

  • Patient Comfort

    1 day, 1 week, 1 month, 3 month and 6 month post-op visits

  • Ocular Hypotensive Medications

    1 week, 1 month, 3 month, and or 6 month post-op visits

Study Arms (2)

Treatment 1(Triesence)

EXPERIMENTAL

glaucoma surgery with 0.2cc Triesence adjunct.

Drug: Triesence

Treatment 2 (balanced salt solution BSS)

ACTIVE COMPARATOR

glaucoma surgery with balanced salt solution, the standard technique.

Drug: balanced salt solution BSS

Interventions

TriesenceDRUG

At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.

Also known as: triamcinolone acetonide injectable
Treatment 1(Triesence)
balanced salt solution BSSDRUG

At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.

Also known as: balanced salt solution
Treatment 2 (balanced salt solution BSS)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
  • primary open angle glaucoma
  • primary angle-closure glaucoma
  • pseudoexfoliation glaucoma
  • pigmentary glaucoma
  • traumatic glaucoma
  • neovascular glaucoma

You may not qualify if:

  • patients that are pregnant, nursing, or not using adequate contraception
  • any other eye surgery except cataract surgery
  • an infection, inflammation, or any abnormality preventing measurement of eye pressure
  • enrolled in another investigational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2.

    PMID: 24794283RESULT

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Angle-ClosureExfoliation SyndromeGlaucoma, Neovascular

Interventions

TriamcinoloneHanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesIris DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Marlene Moster MD
Organization
Wills Eye Hospital Glaucoma Research Center
jmolineaux@willseye.org
215-825-4713

Study Officials

  • Marlene R Moster, MD

    Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon Wills Eye Institute; Professor Jefferson Medical College

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

July 10, 2018

Results First Posted

March 21, 2016

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)