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Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853905
First Posted: March 2, 2009
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye
  Purpose
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.

Condition Intervention Phase
Glaucoma Drug: Triesence Drug: balanced salt solution BSS Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Marlene Moster, MD, Wills Eye:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: Data collected Baseline (before Surgery), 1 day, 1week, 1 month, 3 month and 6 month post-op visits ]
    patient failed the study if IOP was less than 5mmhg for starting IOP or less than a 20% decrease in IOP


Secondary Outcome Measures:
  • A Kowa FM-500 Flare Meter is Used to Measure Inflammation in the Anterior Chamber [ Time Frame: Data collected 1 month, 3 month and 6 month post-op visits ]
    Anterior chamber inflammation measurement is taken 10 times using the Kowa FM-500 flare meter per eye

  • Bleb Morphology Graded by Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS) [ Time Frame: IBAGS assessed at 1 day, 1 week, 1 month, 3 month and 6 month post-op visits; Moorfields Bleb Grading will be done at 1 month, 3 month, and 6 month post-op visits ]
    Bleb appearance is grading using the Moorfields bleb grading system IBAGS; anterior segment slit lamp photos were also done

  • A Patient Comfort Questionnaire [ Time Frame: Patients will be quiered at 1 day, 1 week, 1 month, 3 month and 6 month post-op visit ]
    Dry Eye Scores were lower in the treatment group at 1 month

  • Ocular Hypotensive Medications [ Time Frame: Ocular medications will be documented during the 1 day, 1 week, 1 month, 3 month, and or 6 month post-operative period ]

Enrollment: 77
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1(Triesence)
0.2cc Triesence
Drug: Triesence
At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound
Other Name: triamcinolone acetonide injectable
Active Comparator: Treatment 2 (balanced salt solution BSS)
glaucoma surgery with balanced salt solution, the standard technique used.
Drug: balanced salt solution BSS
standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure.
Other Name: balanced salt solution

Detailed Description:
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.
  Eligibility

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853905


Locations
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Alcon Research
Investigators
Principal Investigator: Marlene R Moster, MD Wills Eye Institute
  More Information

Responsible Party: Marlene Moster, MD, Attending Surgeon Wills Eye Institute; Professor Jefferson Medical College, Wills Eye
ClinicalTrials.gov Identifier: NCT00853905     History of Changes
Other Study ID Numbers: 07-827
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: February 12, 2015
Results First Posted: March 21, 2016
Last Update Posted: January 10, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marlene Moster, MD, Wills Eye:
open angle glaucoma (POAG)
angle closure glaucoma (PACG)
pigmentary glaucoma
pseudoexfoliation glaucoma
neovascular glaucoma
traumatic glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action