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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Treatment 1(Triesence)
    • glaucoma surgery with 0.2cc Triesence adjunct.
  • Active Comparator: Treatment 2 (balanced salt solution BSS)
    • glaucoma surgery with balanced salt solution, the standard technique.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wills Eye
  • Collaborator
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marlene Moster, MD, Attending Surgeon Wills Eye Institute; Professor Jefferson Medical College – Wills Eye
  • Overall Official(s)
    • Marlene R Moster, MD, Principal Investigator, Wills Eye Institute

Citations Reporting on Results

Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.