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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
The intervention consists of the microshunt implantation augmented with mitomycin C application.
The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.
Maastricht University Medical Center+ (MUMC+)
Maastricht, Limburg, Netherlands
Intraocular pressure
The intraocular pressure is measured using a Goldmann applanation tonometer
Time frame: 12 months postoperatively
Visual acuity
Measured with ETDRS letter charts
Time frame: baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Glaucoma medical therapy
number of glaucoma drugs (active substances)
Time frame: 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.
Time frame: 3, 6, 9 and 12 months postoperatively
Complications
The incidence of intraoperative and postoperative complications.
Time frame: Intraoperatively and up to 12 months after the surgery.
Reinterventions
The number of reinterventions after the surgery.
Time frame: Measured up to 12 months after the surgery.
Visual field progression
The progression seen on the visual field.
Time frame: 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.
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Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): GQL-15
Calculated costs per clinically improved patient on the GQL-15 questionnaire
Time frame: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): IOP
Calculated costs per patient with clinically lowered IOP
Time frame: 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).
Time frame: Baseline until 12 months postoperatively