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

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Triesence

balanced salt solution BSS

Sponsored by

Wills Eye

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring open angle glaucoma (POAG), angle closure glaucoma (PACG), pigmentary glaucoma, pseudoexfoliation glaucoma, neovascular glaucoma, traumatic glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wills Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment 1(Triesence)

Treatment 2 (balanced salt solution BSS)

Arm Description

glaucoma surgery with 0.2cc Triesence adjunct.

glaucoma surgery with balanced salt solution, the standard technique.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

Ocular Hypotensive Medications

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

Full Information

NCT ID

First Posted

February 27, 2009

Last Updated

June 11, 2018

Sponsor

Wills Eye

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00853905

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wills Eye

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

open angle glaucoma (POAG), angle closure glaucoma (PACG), pigmentary glaucoma, pseudoexfoliation glaucoma, neovascular glaucoma, traumatic glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment 1(Triesence)

Arm Type

Experimental

Arm Description

glaucoma surgery with 0.2cc Triesence adjunct.

Arm Title

Treatment 2 (balanced salt solution BSS)

Arm Type

Active Comparator

Arm Description

glaucoma surgery with balanced salt solution, the standard technique.

Intervention Type

Drug

Intervention Name(s)

Triesence

Other Intervention Name(s)

triamcinolone acetonide injectable

Intervention Description

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

Intervention Name(s)

balanced salt solution BSS

Other Intervention Name(s)

balanced salt solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular Pressure (IOP)

Description

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 Outcome Measure Information:

Title

Anterior Chamber Inflammation (Flare)

Description

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

Title

Bleb Appearance

Description

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

Title

Patient Comfort

Description

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

Title

Ocular Hypotensive Medications

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marlene R Moster, MD

Organizational Affiliation

Wills Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wills Eye Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

24794283

Citation

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.

Results Reference

result

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

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