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Completed

NCT Number: NCT00853905

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

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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Key information

Conditions

Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma, Angle-Closure Glaucoma, Neovascular Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Uveal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triesence

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.

Other names: triamcinolone acetonide injectable

balanced salt solution BSS

Drug

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

Other names: balanced salt solution

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Alcon Research

Registry information

Official study title

The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Mar 2, 2009
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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