Glaucoma
Conditions
Keywords
open angle glaucoma (POAG), angle closure glaucoma (PACG), pigmentary glaucoma, pseudoexfoliation glaucoma, neovascular glaucoma, traumatic glaucoma
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.
Interventions
DRUGTriesence
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.
DRUGbalanced 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.
Sponsors
Alcon Research
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Inflammation (Flare) | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
February 2009 to July 2011 at the Wills Eye Hospital
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1(Triesence) 0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound | 37 |
| Treatment 2 (Balanced Salt Solution BSS) glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure. | 40 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | never had surgery | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 69 years | 68.5 years |
| Interocular Pressure (mmHg) | 24.5 mmHg | 23.8 mmHg | 24.0 mmHg |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 23 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 17 Participants | 15 Participants | 32 Participants |
| Region of Enrollment United States | 37 participants | 40 participants | 77 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 17 Participants | 23 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 40 |
| other Total, other adverse events | 8 / 37 | 10 / 40 |
| serious Total, serious adverse events | 0 / 37 | 0 / 40 |
Outcome results
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.
Time frame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment 1(Triesence) | Intraocular Pressure (IOP) | Week 1 | 11.7 mm Hg |
| Treatment 1(Triesence) | Intraocular Pressure (IOP) | Month 3 | 15.1 mm Hg |
| Treatment 1(Triesence) | Intraocular Pressure (IOP) | Month 1 | 16.1 mm Hg |
| Treatment 1(Triesence) | Intraocular Pressure (IOP) | Month 6 | 14.6 mm Hg |
| Treatment 1(Triesence) | Intraocular Pressure (IOP) | Day 1 | 16.1 mm Hg |
| Treatment 2 (Balanced Salt Solution BSS) | Intraocular Pressure (IOP) | Month 6 | 13.6 mm Hg |
| Treatment 2 (Balanced Salt Solution BSS) | Intraocular Pressure (IOP) | Day 1 | 12.8 mm Hg |
| Treatment 2 (Balanced Salt Solution BSS) | Intraocular Pressure (IOP) | Week 1 | 11.8 mm Hg |
| Treatment 2 (Balanced Salt Solution BSS) | Intraocular Pressure (IOP) | Month 1 | 14.4 mm Hg |
| Treatment 2 (Balanced Salt Solution BSS) | Intraocular Pressure (IOP) | Month 3 | 12.8 mm Hg |
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).
Time frame: 1 month, 3 month and 6 month post-op visits
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment 1(Triesence) | Anterior Chamber Inflammation (Flare) | Month 1 | 0.4 photon counts per millisecond (p/msec) |
| Treatment 1(Triesence) | Anterior Chamber Inflammation (Flare) | Month 3 | 0.6 photon counts per millisecond (p/msec) |
| Treatment 1(Triesence) | Anterior Chamber Inflammation (Flare) | Month 6 | 0.3 photon counts per millisecond (p/msec) |
| Treatment 2 (Balanced Salt Solution BSS) | Anterior Chamber Inflammation (Flare) | Month 1 | 1.0 photon counts per millisecond (p/msec) |
| Treatment 2 (Balanced Salt Solution BSS) | Anterior Chamber Inflammation (Flare) | Month 3 | 0.4 photon counts per millisecond (p/msec) |
| Treatment 2 (Balanced Salt Solution BSS) | Anterior Chamber Inflammation (Flare) | Month 6 | 0.2 photon counts per millisecond (p/msec) |
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.
Time frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Population: Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment 1(Triesence) | Bleb Appearance | Week 1 | 1.7 units on a scale |
| Treatment 1(Triesence) | Bleb Appearance | Month 3 | 2.0 units on a scale |
| Treatment 1(Triesence) | Bleb Appearance | Month 1 | 2.2 units on a scale |
| Treatment 1(Triesence) | Bleb Appearance | Month 6 | 1.9 units on a scale |
| Treatment 1(Triesence) | Bleb Appearance | Day 1 | 1.7 units on a scale |
| Treatment 2 (Balanced Salt Solution BSS) | Bleb Appearance | Month 6 | 2.1 units on a scale |
| Treatment 2 (Balanced Salt Solution BSS) | Bleb Appearance | Day 1 | 2.1 units on a scale |
| Treatment 2 (Balanced Salt Solution BSS) | Bleb Appearance | Week 1 | 1.9 units on a scale |
| Treatment 2 (Balanced Salt Solution BSS) | Bleb Appearance | Month 1 | 1.9 units on a scale |
| Treatment 2 (Balanced Salt Solution BSS) | Bleb Appearance | Month 3 | 1.8 units on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment 1(Triesence) | Ocular Hypotensive Medications | Week 1 | 0.03 eye drops |
| Treatment 1(Triesence) | Ocular Hypotensive Medications | Month 1 | 0.1 eye drops |
| Treatment 1(Triesence) | Ocular Hypotensive Medications | Month 3 | 0.08 eye drops |
| Treatment 1(Triesence) | Ocular Hypotensive Medications | Month 6 | 0.22 eye drops |
| Treatment 2 (Balanced Salt Solution BSS) | Ocular Hypotensive Medications | Month 6 | 0.22 eye drops |
| Treatment 2 (Balanced Salt Solution BSS) | Ocular Hypotensive Medications | Week 1 | 0.06 eye drops |
| Treatment 2 (Balanced Salt Solution BSS) | Ocular Hypotensive Medications | Month 3 | 0.22 eye drops |
| Treatment 2 (Balanced Salt Solution BSS) | Ocular Hypotensive Medications | Month 1 | 0.03 eye drops |
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.
Time frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment 1(Triesence) | Patient Comfort | Week 1 | 0.6 Patient comfort questionnaire score |
| Treatment 1(Triesence) | Patient Comfort | Month 3 | 0.4 Patient comfort questionnaire score |
| Treatment 1(Triesence) | Patient Comfort | Month 1 | 0.3 Patient comfort questionnaire score |
| Treatment 1(Triesence) | Patient Comfort | Month 6 | 0.7 Patient comfort questionnaire score |
| Treatment 1(Triesence) | Patient Comfort | Day 1 | 0.3 Patient comfort questionnaire score |
| Treatment 2 (Balanced Salt Solution BSS) | Patient Comfort | Month 6 | 0.7 Patient comfort questionnaire score |
| Treatment 2 (Balanced Salt Solution BSS) | Patient Comfort | Day 1 | 0.1 Patient comfort questionnaire score |
| Treatment 2 (Balanced Salt Solution BSS) | Patient Comfort | Week 1 | 0.3 Patient comfort questionnaire score |
| Treatment 2 (Balanced Salt Solution BSS) | Patient Comfort | Month 1 | 0.6 Patient comfort questionnaire score |
| Treatment 2 (Balanced Salt Solution BSS) | Patient Comfort | Month 3 | 0.4 Patient comfort questionnaire score |