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

Wills Eye77 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

TriesenceDRUG

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 BSSDRUG

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits

Secondary Outcomes

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).

Time frame: 1 month, 3 month and 6 month post-op visits

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.

Time frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits

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.

Time frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits

Ocular Hypotensive Medications

Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.

Time frame: 1 week, 1 month, 3 month, and or 6 month post-op visits

Data from ClinicalTrials.gov

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