XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

Glaucoma Clinical Trial

— XEN GPS  

Official title:

XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654885
• Other study ID #: CMO-US-EYE-0600
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: May 13, 2021

Study information

• Verified date: June 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.

Description:

This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN-45 to reduce intraocular pressure (IOP) and reduce the amount of topical IOP-lowering medications in participants poorly controlled on topical therapy. The planned study duration is 12 months. Participants were to be screened for enrollment and eligible candidates were to be approached to ascertain interest in study participation. Eligible participants were to be randomized 2:1; resulting in approximately 95 eyes implanted with XEN-45 and 44 eyes received trabeculetomy by study end.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Open-angle glaucoma where the intraocular pressure (IOP) is not controlled when using topical IOP-lowering glaucoma medication

• Best-corrected baseline Snellen visual acuity of 20/100 or better

• Visual field mean deviation no worse than -18.0 decibels (dB)

• Medicated IOP =15 millimeter of mercury (mm Hg) and =44 mm Hg

• Participants not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 3 months from the time of inclusion

• Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar conjunctiva)

• Trabecular meshwork must be visible (with Shaffer angle grade =2 in the target quadrant)

• Failed ab-interno canal or suprachoroidal micro invasive glaucoma surgery (MIGS) procedures (such as i-Stent, gonioscopy-assisted transluminal trabeculotomy [GATT], Ab-interno canaloplasty [ABiC], Kahook dual blade goniotomy, etc.) are allowed =3 months before enrollment. CyPass® Micro-Stents were not allowed.

Exclusion Criteria:

• Participant has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders

• Participant has had prior ab externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, ultrasound circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle)

• Clinically significant inflammation or infection within 30 days before the preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection)

• Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target area

• History of corneal surgery, corneal opacities, or corneal disease

• Central corneal thickness =490 micrometer (µm) or =620µm

• Vitreous present in the anterior chamber

• Aphakic

• Participant has had prior intraocular surgery in either eye within =3 months before the preoperative visit (including phacoemulsification)

• History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous loss, anterior chamber intraocular lens [ACIOL], perhaps sutured intraocular lens [IOL] or scleral fixated IOL, prior cystoid macular edema [CME], etc.)

• Presence of intraocular silicone oil

• Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, iridocorneal endothelial syndrome [ICE], etc.)

• Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcine products, or glutaraldehyde)

• Pregnant or nursing women and those planning a pregnancy during the study period.

• Participation in another drug or device clinical trial concluding within 30 days before the preoperative visit

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• XEN-45 Gel Stent
XEN-45 gel stent device implant

Procedure:
• Trabeculectomy
Trabeculectomy surgery

Locations

Country	Name	City	State
United States	Kellogg Eye Center University of Michigan health system /ID# 233651	Ann Arbor	Michigan
United States	Retina Institute of California /ID# 233692	Arcadia	California
United States	Georgia Eye Partners /ID# 233655	Atlanta	Georgia
United States	Ludwick Eye Center /ID# 233691	Chambersburg	Pennsylvania
United States	Angeles Eye Institute /ID# 233632	Culver City	California
United States	Glaucoma Associates of Texas /ID# 233587	Dallas	Texas
United States	University of Colorado Denver /ID# 233676	Denver	Colorado
United States	El Paso Eye Surgeons, P.A. /ID# 233584	El Paso	Texas
United States	Vold Vision /ID# 233677	Fayetteville	Arkansas
United States	Carolinas Centers for Sight,PC /ID# 233606	Florence	South Carolina
United States	Eye Surgery Associates /ID# 233638	Hollywood	Florida
United States	Tyrie Lee Jenkins MD Inc. /ID# 233674	Honolulu	Hawaii
United States	Baylor College of Medicine - Baylor Medical Center /ID# 233612	Houston	Texas
United States	Houston Eye Associates /ID# 233621	Houston	Texas
United States	Kremer Eye Center /Id# 233642	King Of Prussia	Pennsylvania
United States	Cha Medical Group Pc /Id# 233649	Los Angeles	California
United States	SSM Health Dean Medical Group /ID# 233624	Madison	Wisconsin
United States	Nashville Vision Associates /ID# 233644	Nashville	Tennessee
United States	Dean McGee Eye Institute /ID# 233595	Oklahoma City	Oklahoma
United States	Stiles Eyecare Excellence /ID# 233583	Overland Park	Kansas
United States	Illinois Eye Center /ID# 233631	Peoria	Illinois
United States	Wills Eye Institute /ID# 233645	Philadelphia	Pennsylvania
United States	university of Pittsburgh /ID# 233622	Pittsburgh	Pennsylvania
United States	The Eye Centers of Racine and Kenosha LTD /ID# 233657	Racine	Wisconsin
United States	Advanced Glaucoma Specialists /ID# 233690	Reading	Massachusetts
United States	Vistar Eye Center /ID# 233652	Roanoke	Virginia
United States	Coastal Research Associates /ID# 233575	Roswell	Georgia
United States	Grutzmacher Lewis and Sierra Inc. /ID# 233654	Sacramento	California
United States	Washington University in St. Louis /ID# 233599	Saint Louis	Missouri
United States	Mayo Clinic Jacksonville /ID# 233634	Saint Paul	Minnesota
United States	Glaucoma associates/consultants of the capital region /ID# 233695	Slingerlands	New York
United States	Carolina Eye Associates /ID# 233656	Southern Pines	North Carolina
United States	Howard University Hospital /ID# 233615	Washington	District of Columbia
United States	Specialty Retina Center /ID# 233628	Weston	Florida
United States	Eye Care Associates Inc /ID# 233636	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats	IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.	Baseline (Preoperative) to Month 12
Secondary	Mean IOP Over Time	IOP is a measurement of the fluid pressure inside the eye.	Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Secondary	Change From Baseline in Mean IOP Over Time	IOP is a measurement of the fluid pressure inside the eye.	Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Secondary	Mean Number of Topical IOP-Lowering Medications Over Time	IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.	Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Secondary	Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time	IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.	Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12
Secondary	Change From Baseline in Mean IOP at Month 12	IOP is a measurement of the fluid pressure inside the eye.	Baseline (Preoperative) and Month 12
Secondary	Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12	IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.	Baseline (Preoperative) and Month 12
Secondary	Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP =18 mm Hg	IOP is a measurement of the fluid pressure inside the eye.	Baseline (Preoperative) and Month 12
Secondary	Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP =18 mm Hg	Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.	Baseline (Preoperative) and Month 12
Secondary	Percentage of Participants Achieving Specific IOP Targets at Month 12	IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): =18, =17, =16, =15, =14, =13, =12 mm Hg.	Month 12
Secondary	Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12	IOP is a measurement of fluid pressure inside the eye. Specific percentage IOP lower targets included =25%, =30%, =35%, =40% =45%, and =50% IOP reduction.	Baseline (Preoperative) to Month 12
Secondary	Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12	IOP is a measurement of fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): =18, =17, =16, =15, =14, =13, =12 mm Hg.	Baseline (Preoperative) and Month 12
Secondary	Percentage of Participants With Needlings Performed	Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.	Up to Month 12
Secondary	Mean Number of Needlings Per Eye	Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.	Up to Month 12
Secondary	Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings	IOP is a measurement of fluid pressure inside the eye. Topical IOP-lowering medication classes include: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.	Month 12
Secondary	Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings	Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.	Month 12
Secondary	Percentage of Participants With Antifibrotic Use During Needling	Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice.	Up to Month 12
Secondary	Percentage of Participants Achieving Complete Success at Month 12	Complete success was defined as IOP =18mm Hg, with 20% or greater IOP lowering from medicated Baseline, on no topical medications, and no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.	Month 12
Secondary	Percentage of Participants Achieving Qualified Success at Month 12	Qualified success was defined as IOP =18 mm Hg, with 20% or greater IOP lowering from medicated Baseline, taking topical medications at Baseline Qualifying Visit, no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.	Month12
Secondary	Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye	IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): =18, =17, =16, =15, =14, =13, =12 mm Hg. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.	Month 12
Secondary	Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes	IOP is a measurement of the fluid pressure inside the eye. Specific percentage IOP lower targets included =25%, =30%, =35%, =40% =45%, and =50% IOP reduction. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.	Month 12
Secondary	Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use	Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice.	Month 12
Secondary	Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration	Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The time of administration was classified into two categories as: Before Procedure and After Procedure.	Month 12
Secondary	Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy	Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The mode of administration was classified into two categories as: Injection and Other. Other includes all other modes of administration apart from injection.	Month 12
Secondary	Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy	Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The volume of administration measured in milliliters (mL) was classified into three categories as: 0.1, 0.2, and Other. Other includes all other volumes apart from 0.1 and 0.2.	Month 12
Secondary	Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy	Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The concentration of administration measured in milligram per milliliter (mg/mL) was classified into three categories as: 0.2, 0.4, and Other. Other includes all other concentrations apart from 0.2 and 0.4.	Month 12
Secondary	Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy	Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The absolute dose of administration measured in microgram per milliliter (µg/mL) was classified into two categories as: 40, and Other. Other includes all other concentrations apart from 40.	Month 12
Secondary	Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses	BCVA was performed using a Snellen eye chart with glasses, and the BCVA data collected in the visual acuity electronic case report form (eCRF) page was analyzed. The number of lines read correctly was assessed as the line change from baseline at each follow-up evaluation and were log transformed. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower and negative logMAR value indicating better visual acuity.	Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12
Secondary	Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale	Manifest Refraction - Mean Visual Acuity was performed using a Snellen eye chart with glasses. The line change from baseline at each follow-up evaluation in logarithm of the minimum angle of resolution (logMAR) was calculated. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.	Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12
Secondary	Mean Surgically Induced Astigmatism - Autorefractor Reading		Month 12
Secondary	Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading		Baseline (Preoperative) and Month 12
Secondary	Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites		Baseline (Preoperative), Week 1, and Months 1 and 12
Secondary	Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth		Baseline, Day 1 and Week 2
Secondary	Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D	The keratometric values for keratometry (K) measured in 2 meridians (i.e., flat keratometry [K1] and steep keratometry [K2]) along with Delta (D) were determined.	Baseline, Day 1 and Week 2
Secondary	Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites		Up to Month 12
Secondary	Bleb Morphology - Slit Lamp Photography at Selected Sites		Up to Month 12
Secondary	Percentage of Participants With Clinical Hypotony	Clinical hypotony was defined as vision reduction (2 lines or more) related to macular changes consistent with hypotony maculopathy (macular folds), optic disc edema, and/or serous choroidal detachments because of low IOP.	Month 12
Secondary	Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment	Eyes with IOP 6 mm Hg or less at any time point and relevant clinical assessment (vision reduction [2 lines or more] related to macular changes consistent with hypotony maculopathy [macular folds], optic disc edema, anterior chamber status, and/or serous choroidal detachments because of low IOP) of these eyes at those time points were assessed. Only data from study eyes are included. The worse eye was selected as the study eye if both eyes met the inclusion criteria. The worse eye was defined using the visual field MD at Baseline, with the worse eye having the most negative MD. In cases where the MD was the same in both eyes to two decimal places, the worse eye was defined as the eye with the higher IOP.	Up to Month 12
Secondary	Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs)	An adverse event(AE)is any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. Intraoperative AESIs included- Detached Descemet's membrane,iris damage,lens contact,vitreous bulge or loss,anterior chamber bleeding,retrobulbar hemorrhage,conjunctival perforation,conjunctival or scleral flap tearing,shallow anterior chamber with peripheral iridocorneal touch,flat anterior chamber with iridocorneal touch extending to the pupil,device malfunction identified prior to implantation,and choroidal hemorrhage of effusion. Only categories with at least one participant with event in the study eye are reported. The worse eye was selected as the study eye if both eyes met inclusion criteria. The worse eye was defined using visual field MD at Baseline, with the worse eye having the most negative MD. If MD was same in both eyes to two decimal places, the worse eye=eye with higher IOP.	Median follow-up of 366.0 days
Secondary	Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs)	AE=any untoward medical occurrence in a clinical investigation participant administered drug;it does not necessarily have to have a causal relationship with the treatment. TEAE is an AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Postoperative AEs included but were not limited to: angle recession, anterior chamber changes, BCVA loss,bleb leak, blebitis, cataract, choroidal effusion, chronic pain, corneal edema, cyclodialysis, Dellen, device malfunction, endophthalmitis, fixed dilated pupil, hyphema, hypotony, implant issues, increase in corneal thickness/IOP, explant, iridodialysis, iritis, loss of eye, etc.Worse eye=eye if both eyes met inclusion criteria. Worse eye was defined using visual field MD at Baseline, with worse eye having the most negative MD. In cases where MD was the same in both eyes to two decimal places, worse eye was defined as eye with higher IOP.	Median follow-up of 366.0 days
Secondary	Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up	The categories = Worsening (<-2), No Change (=-2 and =2), Improving (>2) and Missing were used for determining BCVA worst line change from Baseline. Only categories with at least one participant with event are reported.	Baseline up to Month 12
Secondary	Pachymetry Based on Change From Baseline In Average Central Corneal Thickness	Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline.	Baseline (Preoperative) and Month 12
Secondary	Change From Baseline in Visual Field Examinations Analyzed by Machine Type	All visual field examination data were collected and reported as mean deviation by Humphrey machine.	Baseline and Month 12
Secondary	Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs)	AE=any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. An SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. ADEs and SADEs are AEs and SAEs that are caused by the device	Median follow-up of 366.0 days
Secondary	Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores	The SHPC-18 is an 18-item questionnaire that asks participants being treated for glaucoma questions about eye symptoms or problems they may experience. There are two domains: Local Eye Symptoms (7 items) subscale score 0 to 700 divided by 7 and Visual Function Problem (11 items) subscale score 0 to 1100 divided by 11. The scores of each subscale ranges from from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A frequency score was calculated by summing the individual response scores of each item, and ranges from 0 to 7 for Local Eye Symptom and from 0 to 11 for Visual Function. A total bothersome score for the SHPC-18 is calculated by summing all 18 items scores, resulting in a range from 0 to 1800, then dividing the sum by 18, to create a total bothersome score ranging from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A negative change from Baseline for all scales and subscales indicates improvement.	Baseline (Preoperative) to Month 6
Secondary	PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine	Participants answered the question, "Since your glaucoma surgery, would you consider that you have resumed your usual activities and daily routine?" using the following categories: Not at all, Somewhat, Moderately so, Mostly, Completely.	Month 3
Secondary	PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health	WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.	Baseline (Preoperative) and Month 12
Secondary	PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health	WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.	Baseline (Preoperative) and Month 12

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