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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:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT00853905
First received: February 27, 2009
Last updated: December 21, 2012
Last verified: December 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Wills Eye:

Primary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: Data collected prior to surgery (Baseline visit), 1 day, 1week, 1 month, 3 month and 6 month post-op visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anterior chamber inflammation measurement is taken 10 times using the Kowa FM-500 flare meter per eye [ Time Frame: Data collected 1 month, 3 month and 6 month post-op visits ] [ Designated as safety issue: Yes ]
  • Observation of Triesence Crystals by slit lamp exam combined with gonioscopy [ Time Frame: Data collected 1 day, 1 week, 1 month, 3 month, and 6 month post-op visits ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Lens opacities classification using Lens Opacities Classifications System III (LOCS III) [ Time Frame: Assessesd at baseline, month 3 and month 6 post-operative visit ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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: 1
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: 2
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 27, 2009
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014