Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement

• Sponsor: Prism Eye Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04454138
• Collaborator: Allergan (Industry)
• Enrollment: 142
• Location: 1
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 14.4

Study Details

Study Description

Brief Summary

The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: XEN-45 gelatin microstent

Detailed Description

The Xen-45 gelatin microstent (Allergan, Dublin, Ireland) is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Creation of a filtering bleb through the gel stent and under the conjunctiva lowers intraocular pressure (IOP) by bypassing the natural outflow pathway of aqueous. A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy. Amongst the main advantages of this device is the ability to create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound healing and potentially limiting bleb failure. However, despite demonstrating similar efficacy and safety to trabeculectomy,2 the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. Although antimetabolites, such as mitomycin C, have decreased reactionary wound healing that can result following surgery, fibrosis may still occur, especially when the components of the Xen-45 gelatin microstent are in close proximity to the fibroblastic structures of tenon's fascia.Tenon's capsule resembles a sponge-like layer with multiple adhesions to the overlying conjunctiva and underlying episclera. Implantation of the XEN within this space creates a higher risk of obstruction and subsequent failure. To ensure the lowest potential for occlusion, bleb scarring, and failure, one must ensure careful placement of the device in the subconjunctival space, avoiding intra-tenon's placement. Placement in the supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Study Design

• Study Type: Observational
• Actual Enrollment: 142 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement
• Actual Study Start Date: Jun 25, 2019
• Actual Primary Completion Date: Apr 20, 2020
• Actual Study Completion Date: Apr 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Targeted supratenon's placement of XEN 45 Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.	Device: XEN-45 gelatin microstent; Placement either in the subconjunctival space or supratenon's area
Non-targeted placement of XEN 45 Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.	Device: XEN-45 gelatin microstent; Placement either in the subconjunctival space or supratenon's area

Outcome Measures

Primary Outcome Measures

1. Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement. [Post op year 1]

   Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications

2. Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2. [Post op Year 1]

   Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications

3. Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3. [Post op year 1]

   Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications

4. Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4. [Post op Year 1]

   Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication

5. Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5. [Post op Year 1]

   Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications

6. Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6. [Post op year 1]

   Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications

Secondary Outcome Measures

1. Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. [Post op year 1]

   Presence or absence of the following complications: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis

2. Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. [Post op year 1]

   Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

Exclusion Criteria:

• Other forms of glaucoma

• Prior incisional glaucoma surgery

• CPC

• Prior corneal graft (PKP, DALK, DSAEK, DMEK).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prism Eye Institute	Oakville	Ontario	Canada	L6H 0J8

Sponsors and Collaborators

• Prism Eye Institute
• Allergan

Investigators

• Principal Investigator: Iqbal Ike Ahmed, MD, Prism Eye Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 14, 2018

More Information

Publications

• Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17. Review.
• Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20.
• Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7. Erratum in: Ophthalmology. 2018 Mar;125(3):463.
• Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29.

• Responsible Party: Iqbal Ahmed, Principal Investigator, Prism Eye Institute
• ClinicalTrials.gov Identifier: NCT04454138
• Other Study ID Numbers: 955
• First Posted: Jul 1, 2020
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glaucoma

Study Results

Participant Flow

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Period Title: Overall Study
STARTED	65	77
COMPLETED	65	77
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45	Total
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Total of all reporting groups
Overall Participants	65	77	142
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	65.4	78	70.9
Sex: Female, Male (Count of Participants)
Female	27 41.5%	36 46.8%	63 44.4%
Male	38 58.5%	41 53.2%	79 55.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	12 18.5%	11 14.3%	23 16.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 12.3%	2 2.6%	10 7%
White	41 63.1%	59 76.6%	100 70.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 6.2%	5 6.5%	9 6.3%
Region of Enrollment (participants) [Number]
Canada	65 100%	77 100%	142 100%
Diabetic (Count of Participants)
Count of Participants [Participants]	22 33.8%	11 14.3%	33 23.2%
Preoperative Best Corrected Visual Acuity (BCVA) (logMAR) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [logMAR]	0.2	0.3	0.2
Number of Patients who received XEN 45 in Left Eye (Count of Participants)
Count of Participants [Participants]	32 49.2%	36 46.8%	68 47.9%
IOP > 21 mmHg (Count of Participants)
Count of Participants [Participants]	32 49.2%	42 54.5%	74 52.1%
IOP median (mmHg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mmHg]	21	22	21
Medication Classes (Medication Classes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Medication Classes]	4	4	4
Primary Open Angle Glaucoma (Count of Participants)
Count of Participants [Participants]	48 73.8%	42 54.5%	90 63.4%
Pseudoexfoliation (Count of Participants)
Count of Participants [Participants]	7 10.8%	21 27.3%	28 19.7%
Pigment Dispersion Glaucoma (Count of Participants)
Count of Participants [Participants]	3 4.6%	0 0%	3 2.1%
Primary Angle Closure Glaucoma (Count of Participants)
Count of Participants [Participants]	1 1.5%	7 9.1%	8 5.6%
Combined Mechanism Glaucoma (Count of Participants)
Count of Participants [Participants]	6 9.2%	7 9.1%	13 9.2%
Cup to Disk Ratio (Ratio) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Ratio]	0.9	0.8	0.8
Preoperative Mean Deviation on Visual Field to Normal Population (decibel) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [decibel]	-8.4	-1.7	-4
Mild Disease (Count of Participants)
Count of Participants [Participants]	22 33.8%	52 67.5%	74 52.1%
Moderate to Severe Disease (Count of Participants)
Count of Participants [Participants]	42 64.6%	25 32.5%	67 47.2%
Laser Peripheral Iridotomy (Count of Participants)
Count of Participants [Participants]	8 12.3%	16 20.8%	24 16.9%
Laser Trabeculoplasty (Count of Participants)
Count of Participants [Participants]	47 72.3%	41 53.2%	88 62%
Concomitant Cataract Surgery (Count of Participants)
Count of Participants [Participants]	24 36.9%	38 49.4%	62 43.7%

Outcome Measures

1. Primary Outcome

Title	Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.
Description	Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications
Time Frame	Post op year 1

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	20 30.8%	15 19.5%

2. Primary Outcome

Title	Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.
Description	Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications
Time Frame	Post op Year 1

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	33 50.8%	22 28.6%

3. Primary Outcome

Title	Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.
Description	Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications
Time Frame	Post op year 1

Outcome Measure Data

Analysis Population Description

Per protocol polulation

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	28 43.1%	18 23.4%

4. Primary Outcome

Title	Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.
Description	Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication
Time Frame	Post op Year 1

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	41 63.1%	26 33.8%

5. Primary Outcome

Title	Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.
Description	Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications
Time Frame	Post op Year 1

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	31 47.7%	19 24.7%

6. Primary Outcome

Title	Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.
Description	Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications
Time Frame	Post op year 1

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	47 72.3%	28 36.4%

7. Secondary Outcome

Title	Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
Description	Presence or absence of the following complications: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis
Time Frame	Post op year 1

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	35 53.8%	48 62.3%

8. Secondary Outcome

Title	Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
Description	Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.
Time Frame	Post op year 1

Outcome Measure Data

Analysis Population Description

per protocol population

Arm/Group Title	Non-targeted Placement of XEN 45	Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area	Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
Measure Participants	65	77
Count of Participants [Participants]	32 49.2%	40 51.9%

Adverse Events

Time Frame	1 year
Arm/Group Title	Non-targeted Placement of XEN 45		Targeted Supratenon's Placement of XEN 45
Arm/Group Description	Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area		Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
All Cause Mortality
	Non-targeted Placement of XEN 45		Targeted Supratenon's Placement of XEN 45
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/77 (0%)
Serious Adverse Events
	Non-targeted Placement of XEN 45		Targeted Supratenon's Placement of XEN 45
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Non-targeted Placement of XEN 45		Targeted Supratenon's Placement of XEN 45
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/77 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.