SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy. (SIGHT)

SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Open-angle Glaucoma
• Intervention / Treatment: Procedure: PRESERFLO Microshunt implantation; Procedure: Trabeculectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lotte Scheres, MD; Phone Number: 0031 433877343; Email: lotte.scheres@mumc.nl
• Study Contact Backup: Name: Frank van den Biggelaar, PhD; Phone Number: 0031 43877344

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Maastricht University Medical Center+ (MUMC+)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

1. 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
2. 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).
3. Previous incisional surgery of the subject eye. Previous uncomplicated clear corneal cataract surgery is allowed >6 months prior to the surgery.
4. 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).
5. Any ocular comorbidities that could affect the visual field. (e.g. diabetic retinopathy, proliferative retinopathy, aphakia, degenerative visual disorder not associated with glaucoma)
6. Chronic or recurrent uveitis.
7. Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery.
8. Anatomical factors that increase the risk of complicated surgery (due to previous trauma, anatomical abnormalities, anterior synechiae or previous cyclodestructive procedure).

9. 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
10. Contraindication or allergy to mitomycin C.
11. Any contraindication to tube placement (e.g. shallow anterior chamber, insufficient endothelial cell density).
12. Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
13. Prior ocular laser treatment within 3 months of the surgery, increasing the risk of in-flammation in the eye.
14. Corneal thickness <450um or >620microns.
15. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy.
16. Among patients in whom both eyes are eligible only the first eye is undergoing surgical treatment is enrolled in the study.
17. Participation in another clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS)); The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS).	Procedure: PRESERFLO Microshunt implantation; The intervention consists of the microshunt implantation augmented with mitomycin C application.; Other Names: InnFocus Microshunt implantation
Active Comparator: Trabeculectomy; The usual care/control group will undergo a standard trabeculectomy.	Procedure: Trabeculectomy; The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	The intraocular pressure is measured using a Goldmann applanation tonometer	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Measured with ETDRS letter charts	baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Glaucoma medical therapy	number of glaucoma drugs (active substances)	at baseline and 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
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.	3, 6, 9 and 12 months postoperatively
Complications	The incidence of intraoperative and postoperative complications.	Intraoperatively and up to 12 months after the surgery.
Reinterventions	The number of reinterventions after the surgery.	Measured up to 12 months after the surgery.
Visual field progression	The progression seen on the visual field.	measured twice at baseline and twice after 12 months of follow-up.
Mean endothelial cell loss	The endothelial cell density will be measured using specular microscopy photography.	measured at baseline and after 12 months of follow-up.
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).	measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
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).	measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Patient- reported outcome measures (PROMs): EuroQol's EQ-5D-5L	Health-related quality of life as measured by EuroQol's EQ-5D-5L questionnaire.	measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Patient- reported outcome measures (PROMs): HUI3	Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.	measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Quality Adjusted Life Years (QALYs)	Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires	Baseline until 12 months postoperatively
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.	Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY	Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)	Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25	Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire	Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): GQL-15	Calculated costs per clinically improved patient on the GQL-15 questionnaire	Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): IOP	Calculated costs per patient with clinically lowered IOP	Baseline until 12 months postoperatively
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).	Baseline until 12 months postoperatively

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Henny Beckers, MD, PhD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Glaucoma, Open-Angle; Trabeculectomy; Minimally invasive glaucoma surgery; InnFocus Microshunt; PRESERFLO Microshunt
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: NL68964.068.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No