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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment 1(Triesence)

glaucoma surgery with 0.2cc Triesence adjunct.

Group Type EXPERIMENTAL

Triesence

Intervention Type DRUG

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.

Treatment 2 (balanced salt solution BSS)

glaucoma surgery with balanced salt solution, the standard technique.

Group Type ACTIVE_COMPARATOR

balanced salt solution BSS

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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triamcinolone acetonide injectable balanced salt solution

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No