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

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Dietary Sodium Glaucoma

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Sodium chloride

U.S. FDA Resources

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

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
Ocular Hypertension
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013