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

Primary Open-angle Glaucoma Clinical Trial

— SIGHT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03931564
• Other study ID #: NL68964.068.19
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Procedure:
• PRESERFLO Microshunt implantation
The intervention consists of the microshunt implantation augmented with mitomycin C application.
• Trabeculectomy
The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+ (MUMC+)	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	The intraocular pressure is measured using a Goldmann applanation tonometer	12 months postoperatively
Secondary	Visual acuity	Measured with ETDRS letter charts	baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Secondary	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
Secondary	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
Secondary	Complications	The incidence of intraoperative and postoperative complications.	Intraoperatively and up to 12 months after the surgery.
Secondary	Reinterventions	The number of reinterventions after the surgery.	Measured up to 12 months after the surgery.
Secondary	Visual field progression	The progression seen on the visual field.	measured twice at baseline and twice after 12 months of follow-up.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incremental cost-effectiveness ratios (ICERs): GQL-15	Calculated costs per clinically improved patient on the GQL-15 questionnaire	Baseline until 12 months postoperatively
Secondary	Incremental cost-effectiveness ratios (ICERs): IOP	Calculated costs per patient with clinically lowered IOP	Baseline until 12 months postoperatively
Secondary	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