Primary Open-angle GlaucomaSIGHTNCT03931564
SIGHT Study: Cost-effectiveness of InnFocus Microshunt Implantation vs. Trabeculectomy.
A study testing PRESERFLO Microshunt implantation and Trabeculectomy in people with Primary Open-angle Glaucoma, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- PRESERFLO Microshunt implantation and Trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+ (MUMC+)
Maastricht, Limburg, 6229HX
About this study
Official title: 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).
Read the 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.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- PRESERFLO Microshunt implantation, Trabeculectomy
- Keywords
- Glaucoma, Open-Angle, Trabeculectomy, Intraocular Pressure, Minimally invasive glaucoma surgery, InnFocus Microshunt, PRESERFLO Microshunt
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESERFLO Microshunt implantationProcedure or surgery
Also called InnFocus Microshunt implantation
The intervention consists of the microshunt implantation augmented with mitomycin C application.
TrabeculectomyProcedure or surgery
The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.
| Study group | Role | What they receive |
|---|---|---|
| PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS)) | Active comparator | The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS). Receives: Procedure: PRESERFLO Microshunt implantation |
| Trabeculectomy | Active comparator | The usual care/control group will undergo a standard trabeculectomy. Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
The intraocular pressure is measured using a Goldmann applanation tonometer
Measured: 12 months postoperatively
Secondary outcomes (18)
Visual acuity
Measured with ETDRS letter charts
Measured: baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Glaucoma medical therapy
number of glaucoma drugs (active substances)
Measured: 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.
Measured: 3, 6, 9 and 12 months postoperatively
Complications
The incidence of intraoperative and postoperative complications.
Measured: Intraoperatively and up to 12 months after the surgery.
Reinterventions
The number of reinterventions after the surgery.
Measured: Measured up to 12 months after the surgery.
Visual field progression
The progression seen on the visual field.
Measured: 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: 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: 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: 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: 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: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): GQL-15
Calculated costs per clinically improved patient on the GQL-15 questionnaire
Measured: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): IOP
Calculated costs per patient with clinically lowered IOP
Measured: 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).
Measured: Baseline until 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Feb 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Henny Beckers, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931564
- Sponsor's protocol ID
- NL68964.068.19
- Acronym
- SIGHT
- Status last verified
- Oct 2023
- First submitted
- 23 Apr 2019
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scheres LMJ, van den Biggelaar FJHM, Winkens B, Kujovic-Aleksov S, Muskens RPHM, de Waard PWT, de Crom RMPC, Ernest PJG, Pijl BJ, Ramdas WD, van Rijn LJ, Tan A, Dirksen CD, Beckers HJM. Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial. BMC Ophthalmol. 2023 Jan 31;23(1):43. doi: 10.1186/s12886-022-02734-y.
PubMed 36721130
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)
- ClinicalTrials.gov ID
- NCT03931564
- Acronym / sponsor ID
- SIGHT / NL68964.068.19
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Glaucoma, Open-Angle, Trabeculectomy, Intraocular Pressure, Minimally invasive glaucoma surgery, InnFocus Microshunt, PRESERFLO Microshunt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS)) | Active comparator | Procedure: PRESERFLO Microshunt implantationThe intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS). |
| Trabeculectomy | Active comparator | Procedure: TrabeculectomyThe usual care/control group will undergo a standard trabeculectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESERFLO Microshunt implantationAlso: InnFocus Microshunt implantationThe intervention consists of the microshunt implantation augmented with mitomycin C application. | Procedure or surgery | PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS)) |
| TrabeculectomyThe usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application. | Procedure or surgery | Trabeculectomy |
Primary outcome
Intraocular pressure
Time frame: 12 months postoperatively
The intraocular pressure is measured using a Goldmann applanation tonometer
18 secondary outcomes
Visual acuity
Time frame: baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Glaucoma medical therapy
Time frame: at baseline and 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively
Failure rate
Time frame: 3, 6, 9 and 12 months postoperatively
Complications
Time frame: Intraoperatively and up to 12 months after the surgery.
Reinterventions
Time frame: Measured up to 12 months after the surgery.
Visual field progression
Time frame: measured twice at baseline and twice after 12 months of follow-up.
Mean endothelial cell loss
Time frame: measured at baseline and after 12 months of follow-up.
Patient- reported outcome measures (PROMs): NEI-VFQ-25
Time frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Patient- reported outcome measures (PROMs): 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
Time frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Patient- reported outcome measures (PROMs): HUI3
Time frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively
Quality Adjusted Life Years (QALYs)
Time frame: Baseline until 12 months postoperatively
Costs per patient
Time frame: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Time frame: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Time frame: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): GQL-15
Time frame: Baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): IOP
Time frame: Baseline until 12 months postoperatively
Budget impact
Time frame: Baseline until 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 36721130Scheres LMJ, van den Biggelaar FJHM, Winkens B, Kujovic-Aleksov S, Muskens RPHM, de Waard PWT, de Crom RMPC, Ernest PJG, Pijl BJ, Ramdas WD, van Rijn LJ, Tan A, Dirksen CD, Beckers HJM. Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial. BMC Ophthalmol. 2023 Jan 31;23(1):43. doi: 10.1186/s12886-022-02734-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henny Beckers, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRESERFLO Microshunt implantation and Trabeculectomy in people with Primary Open-angle Glaucoma, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.