Clinical trial NCT03931564: SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy.
Official title: SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Open-angle Glaucoma
Keywords: Glaucoma, Open-Angle
Trabeculectomy
Intraocular Pressure
Minimally invasive glaucoma surgery
InnFocus Microshunt
PRESERFLO Microshunt
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2019-04-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Intraocular pressure
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Visual acuity
timeFrame: baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
measure: Glaucoma medical therapy
timeFrame: at baseline and 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
measure: Failure rate
timeFrame: 3, 6, 9 and 12 months postoperatively
measure: Complications
timeFrame: Intraoperatively and up to 12 months after the surgery.
measure: Reinterventions
timeFrame: Measured up to 12 months after the surgery.
measure: Visual field progression
timeFrame: measured twice at baseline and twice after 12 months of follow-up.
measure: Mean endothelial cell loss
timeFrame: measured at baseline and after 12 months of follow-up.
measure: Patient- reported outcome measures (PROMs): NEI-VFQ-25
timeFrame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
measure: Patient- reported outcome measures (PROMs): GQL-15
timeFrame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
measure: Patient- reported outcome measures (PROMs): EuroQol's EQ-5D-5L
timeFrame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
measure: Patient- reported outcome measures (PROMs): HUI3
timeFrame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
measure: Quality Adjusted Life Years (QALYs)
timeFrame: Baseline until 12 months postoperatively
measure: Costs per patient
timeFrame: Baseline until 12 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): QALY
timeFrame: Baseline until 12 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
timeFrame: Baseline until 12 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): GQL-15
timeFrame: Baseline until 12 months postoperatively
measure: Incremental cost-effectiveness ratios (ICERs): IOP
timeFrame: Baseline until 12 months postoperatively
measure: Budget impact
timeFrame: Baseline until 12 months postoperatively
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+ (MUMC+)
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Henny Beckers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: