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

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ClinicalTrials.gov Identifier: NCT00853905
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : March 21, 2016
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Triesence Drug: balanced salt solution BSS Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Sodium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment 1(Triesence)
glaucoma surgery with 0.2cc Triesence adjunct.
 Drug: Triesence
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.
Other Name: triamcinolone acetonide injectable
Active Comparator: Treatment 2 (balanced salt solution BSS)
glaucoma surgery with balanced salt solution, the standard technique.
 Drug: balanced salt solution BSS
At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
Other Name: balanced salt solution


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits ]
    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.


Secondary Outcome Measures :
  1. Anterior Chamber Inflammation (Flare) [ Time Frame: 1 month, 3 month and 6 month post-op visits ]
    Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).

  2. Bleb Appearance [ Time Frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits ]
    A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.

  3. Patient Comfort [ Time Frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits ]
    Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.

  4. Ocular Hypotensive Medications [ Time Frame: 1 week, 1 month, 3 month, and or 6 month post-op visits ]
    Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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
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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
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United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Alcon Research
Investigators
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Principal Investigator: Marlene R Moster, MD Wills Eye Institute
More Information
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Publications of Results:

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Responsible Party: Marlene Moster, MD, Attending Surgeon Wills Eye Institute; Professor Jefferson Medical College, Wills Eye
ClinicalTrials.gov Identifier: NCT00853905    
Other Study ID Numbers: 07-827
First Posted: March 2, 2009    Key Record Dates
Results First Posted: March 21, 2016
Last Update Posted: July 10, 2018
Last Verified: June 2018
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:
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Glaucoma
Ocular Hypertension
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Pharmaceutical Solutions
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