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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853905
• Other study ID #: 07-827
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Alcon Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	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.	1 day, 1week, 1 month, 3 month and 6 month post-op visits
Secondary	Anterior Chamber Inflammation (Flare)	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).	1 month, 3 month and 6 month post-op visits
Secondary	Bleb Appearance	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.	1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Secondary	Patient Comfort	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.	1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Secondary	Ocular Hypotensive Medications	Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.	1 week, 1 month, 3 month, and or 6 month post-op visits