Back to resultsSIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy. (SIGHT)
Primary Purpose
Primary Open-angle Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PRESERFLO Microshunt implantation
Trabeculectomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Glaucoma, Open-Angle, Trabeculectomy, Intraocular Pressure, Minimally invasive glaucoma surgery, InnFocus Microshunt, PRESERFLO Microshunt
Eligibility Criteria
Inclusion Criteria:
- Adult Caucasian patients aged between 18 and 80 years old with uncontrolled primary open angle glaucoma on (maximum tolerated) medical therapy and/or progression of visual field loss, an IOP ≥18 and ≤40 mmHg, and an indication for primary glaucoma surgery (trabeculectomy) are suitable for inclusion.
Exclusion Criteria:
- Patient unwilling or unable to give informed consent, unwilling to accept randomization or inability to complete follow-up (e.g. hospital visits) or comply with study procedures
- Secondary glaucoma (e.g. pigment dispersion syndrome, pseudo exfoliation syn-drome, iris neovascularization, rubeosis iridis, trauma, epithelial or fibrous down growth, iridocorneal endothelial syndrome, etcetera).
- Previous incisional surgery of the subject eye. Previous uncomplicated clear corneal cataract surgery is allowed >6 months prior to the surgery.
- Poor vision in either the study or fellow eye. Poor vision is defined as a corrected vis-ual acuity <0.6 and/or a visual field loss within the central 10 degrees (with exception of a superior altitudinal defect).
- Any ocular comorbidities that could affect the visual field. (e.g. diabetic retinopathy, proliferative retinopathy, aphakia, degenerative visual disorder not associated with glaucoma)
- Chronic or recurrent uveitis.
- Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery.
- Anatomical factors that increase the risk of complicated surgery (due to previous trauma, anatomical abnormalities, anterior synechiae or previous cyclodestructive procedure).
Conditions that increase the risk of endophthalmitis.
- Current ocular, adnexal or periocular infections (e.g., untreated blepharitis)
- Immune compromised patients including the use of topical or systemic steroids for an indication other than the surgery within 3 months of the procedure (this would not include the use of inhaled or dermatologic steroids), chemotherapy within 6 months of the procedure.
- Iodine allergy
- Unwilling to discontinue contact lens after surgery
- Contraindication or allergy to mitomycin C.
- Any contraindication to tube placement (e.g. shallow anterior chamber, insufficient endothelial cell density).
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- Prior ocular laser treatment within 3 months of the surgery, increasing the risk of in-flammation in the eye.
- Corneal thickness <450um or >620microns.
- Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy.
- Among patients in whom both eyes are eligible only the first eye is undergoing surgical treatment is enrolled in the study.
- Participation in another clinical study.
Sites / Locations
- Maastricht University Medical Center+ (MUMC+)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))
Trabeculectomy
Arm Description
The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS).
The usual care/control group will undergo a standard trabeculectomy.
Outcomes
Primary Outcome Measures
Intraocular pressure
The intraocular pressure is measured using a Goldmann applanation tonometer
Secondary Outcome Measures
Visual acuity
Measured with ETDRS letter charts
Glaucoma medical therapy
number of glaucoma drugs (active substances)
Failure rate
Failure is defined as an IOP >21 mmHg and ≤ 5 mmHg or less than 20% reduction relative to baseline IOP at two consecutive follow-up visits after 3 months. Reoperation will also be defined as failure.
Complications
The incidence of intraoperative and postoperative complications.
Reinterventions
The number of reinterventions after the surgery.
Visual field progression
The progression seen on the visual field.
Mean endothelial cell loss
The endothelial cell density will be measured using specular microscopy photography.
Patient- reported outcome measures (PROMs): NEI-VFQ-25
Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
Patient- reported outcome measures (PROMs): GQL-15
Patient satisfaction and vision-specific quality of life as measured by Glaucoma Quality of Life-15 (GQL-15).
Patient- reported outcome measures (PROMs): EuroQol's EQ-5D-5L
Health-related quality of life as measured by EuroQol's EQ-5D-5L questionnaire.
Patient- reported outcome measures (PROMs): HUI3
Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.
Quality Adjusted Life Years (QALYs)
Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires
Costs per patient
Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.
Incremental cost-effectiveness ratios (ICERs): QALY
Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire
Incremental cost-effectiveness ratios (ICERs): GQL-15
Calculated costs per clinically improved patient on the GQL-15 questionnaire
Incremental cost-effectiveness ratios (ICERs): IOP
Calculated costs per patient with clinically lowered IOP
Budget impact
Reported as a difference in costs. Different scenario's will be compared to investigate the impact of various levels of implementation (e.g. 25%, 50%, 75% of eligible patients).
Full Information
NCT ID
NCT03931564
First Posted
April 23, 2019
Last Updated
August 16, 2022
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03931564
Brief Title
SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy.
Acronym
SIGHT
Official Title
SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The standard surgical treatment for glaucoma is trabeculectomy. The PRESERFLO™ (formerly InnFocus) Microshunt (IMS) is a new, minimally invasive drainage device which has been suggested to result in similar IOP lowering, but with faster visual recovery and less complications and postoperative interventions. The objective of this study is to aid in deciding on the use of the IMS in glaucoma surgery by assessing its efficacy and cost-effectiveness in patients with primary open angle glaucoma (POAG) compared to the standard trabeculectomy (TE).
Detailed Description
During the last decade, minimally invasive glaucoma surgery (MIGS) procedures have been introduced to the market. MIGS procedures or devices, often small stents or tubes that can be placed into the eye, are potentially safer than standard trabeculectomy (TE). The surgery is faster and easier to perform. Patient recovery is faster with fewer postoperative visits, suggesting less impact on vision and quality of life. However, MIGS devices are more expensive compared to standard surgery and it is unclear if the higher costs can be compensated with their better safety profile and faster patient recovery (reduced productivity losses).
To establish guidelines for the use of MIGS, the Netherlands Glaucoma Group has recognized the need for a formal investigation of their cost-effectiveness as compared to TE, prior to their implementation on a large scale for regular care. Therefore, a societal cost-effectiveness analysis of MIGS procedures will be undertaken to further elucidate their position in the glaucoma treatment algorithm in the Netherlands.
The objective of this study is to aid in deciding on the use of the IMS in glaucoma surgery by assessing its efficacy and cost-effectiveness in patients with primary open angle glaucoma compared to trabeculectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
Glaucoma, Open-Angle, Trabeculectomy, Intraocular Pressure, Minimally invasive glaucoma surgery, InnFocus Microshunt, PRESERFLO Microshunt
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))
Arm Type
Active Comparator
Arm Description
The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS).
Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
The usual care/control group will undergo a standard trabeculectomy.
Intervention Type
Procedure
Intervention Name(s)
PRESERFLO Microshunt implantation
Other Intervention Name(s)
InnFocus Microshunt implantation
Intervention Description
The intervention consists of the microshunt implantation augmented with mitomycin C application.
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
The intraocular pressure is measured using a Goldmann applanation tonometer
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Measured with ETDRS letter charts
Time Frame
baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Title
Glaucoma medical therapy
Description
number of glaucoma drugs (active substances)
Time Frame
at baseline and 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Title
Failure rate
Description
Failure is defined as an IOP >21 mmHg and ≤ 5 mmHg or less than 20% reduction relative to baseline IOP at two consecutive follow-up visits after 3 months. Reoperation will also be defined as failure.
Time Frame
3, 6, 9 and 12 months postoperatively
Title
Complications
Description
The incidence of intraoperative and postoperative complications.
Time Frame
Intraoperatively and up to 12 months after the surgery.
Title
Reinterventions
Description
The number of reinterventions after the surgery.
Time Frame
Measured up to 12 months after the surgery.
Title
Visual field progression
Description
The progression seen on the visual field.
Time Frame
measured twice at baseline and twice after 12 months of follow-up.
Title
Mean endothelial cell loss
Description
The endothelial cell density will be measured using specular microscopy photography.
Time Frame
measured at baseline and after 12 months of follow-up.
Title
Patient- reported outcome measures (PROMs): NEI-VFQ-25
Description
Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
Time Frame
measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Title
Patient- reported outcome measures (PROMs): GQL-15
Description
Patient satisfaction and vision-specific quality of life as measured by Glaucoma Quality of Life-15 (GQL-15).
Time Frame
measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Title
Patient- reported outcome measures (PROMs): EuroQol's EQ-5D-5L
Description
Health-related quality of life as measured by EuroQol's EQ-5D-5L questionnaire.
Time Frame
measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Title
Patient- reported outcome measures (PROMs): HUI3
Description
Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.
Time Frame
measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Title
Quality Adjusted Life Years (QALYs)
Description
Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires
Time Frame
Baseline until 12 months postoperatively
Title
Costs per patient
Description
Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.
Time Frame
Baseline until 12 months postoperatively
Title
Incremental cost-effectiveness ratios (ICERs): QALY
Description
Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)
Time Frame
Baseline until 12 months postoperatively
Title
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Description
Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire
Time Frame
Baseline until 12 months postoperatively
Title
Incremental cost-effectiveness ratios (ICERs): GQL-15
Description
Calculated costs per clinically improved patient on the GQL-15 questionnaire
Time Frame
Baseline until 12 months postoperatively
Title
Incremental cost-effectiveness ratios (ICERs): IOP
Description
Calculated costs per patient with clinically lowered IOP
Time Frame
Baseline until 12 months postoperatively
Title
Budget impact
Description
Reported as a difference in costs. Different scenario's will be compared to investigate the impact of various levels of implementation (e.g. 25%, 50%, 75% of eligible patients).
Time Frame
Baseline until 12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Caucasian patients aged between 18 and 80 years old with uncontrolled primary open angle glaucoma on (maximum tolerated) medical therapy and/or progression of visual field loss, an IOP ≥18 and ≤40 mmHg, and an indication for primary glaucoma surgery (trabeculectomy) are suitable for inclusion.
Exclusion Criteria:
Patient unwilling or unable to give informed consent, unwilling to accept randomization or inability to complete follow-up (e.g. hospital visits) or comply with study procedures
Secondary glaucoma (e.g. pigment dispersion syndrome, pseudo exfoliation syn-drome, iris neovascularization, rubeosis iridis, trauma, epithelial or fibrous down growth, iridocorneal endothelial syndrome, etcetera).
Previous incisional surgery of the subject eye. Previous uncomplicated clear corneal cataract surgery is allowed >6 months prior to the surgery.
Poor vision in either the study or fellow eye. Poor vision is defined as a corrected vis-ual acuity <0.6 and/or a visual field loss within the central 10 degrees (with exception of a superior altitudinal defect).
Any ocular comorbidities that could affect the visual field. (e.g. diabetic retinopathy, proliferative retinopathy, aphakia, degenerative visual disorder not associated with glaucoma)
Chronic or recurrent uveitis.
Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery.
Anatomical factors that increase the risk of complicated surgery (due to previous trauma, anatomical abnormalities, anterior synechiae or previous cyclodestructive procedure).
Conditions that increase the risk of endophthalmitis.
Current ocular, adnexal or periocular infections (e.g., untreated blepharitis)
Immune compromised patients including the use of topical or systemic steroids for an indication other than the surgery within 3 months of the procedure (this would not include the use of inhaled or dermatologic steroids), chemotherapy within 6 months of the procedure.
Iodine allergy
Unwilling to discontinue contact lens after surgery
Contraindication or allergy to mitomycin C.
Any contraindication to tube placement (e.g. shallow anterior chamber, insufficient endothelial cell density).
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Prior ocular laser treatment within 3 months of the surgery, increasing the risk of in-flammation in the eye.
Corneal thickness <450um or >620microns.
Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy.
Among patients in whom both eyes are eligible only the first eye is undergoing surgical treatment is enrolled in the study.
Participation in another clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lotte Scheres, MD
Phone
433877343
Ext
0031
Email
lotte.scheres@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Frank van den Biggelaar, PhD
Phone
43877344
Ext
0031
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henny Beckers, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center+ (MUMC+)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Scheres, MD
First Name & Middle Initial & Last Name & Degree
H.J.M. Beckers, MD, PhD
First Name & Middle Initial & Last Name & Degree
F.J.H.M. van den Biggelaar, PhD
First Name & Middle Initial & Last Name & Degree
L.M.J. Scheres, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy.
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