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

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ClinicalTrials.gov Identifier: NCT03931564
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

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).

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Procedure: PRESERFLO Microshunt implantation Procedure: Trabeculectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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 Name: 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.




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 12 months postoperatively ]
    The intraocular pressure is measured using a Goldmann applanation tonometer


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively ]
    Measured with ETDRS letter charts

  2. Glaucoma medical therapy [ Time Frame: at baseline and 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively ]
    number of glaucoma drugs (active substances)

  3. Failure rate [ Time Frame: 3, 6, 9 and 12 months postoperatively ]
    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.

  4. Complications [ Time Frame: Intraoperatively and up to 12 months after the surgery. ]
    The incidence of intraoperative and postoperative complications.

  5. Reinterventions [ Time Frame: Measured up to 12 months after the surgery. ]
    The number of reinterventions after the surgery.

  6. Visual field progression [ Time Frame: measured twice at baseline and twice after 12 months of follow-up. ]
    The progression seen on the visual field.

  7. Mean endothelial cell loss [ Time Frame: measured at baseline and after 12 months of follow-up. ]
    The endothelial cell density will be measured using specular microscopy photography.

  8. Patient- reported outcome measures (PROMs): NEI-VFQ-25 [ Time Frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively ]
    Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

  9. Patient- reported outcome measures (PROMs): GQL-15 [ Time Frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively ]
    Patient satisfaction and vision-specific quality of life as measured by Glaucoma Quality of Life-15 (GQL-15).

  10. Patient- reported outcome measures (PROMs): EuroQol's EQ-5D-5L [ Time Frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively ]
    Health-related quality of life as measured by EuroQol's EQ-5D-5L questionnaire.

  11. Patient- reported outcome measures (PROMs): HUI3 [ Time Frame: measured at baseline, 4 weeks, 3, 6, and 12 months postoperatively ]
    Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.

  12. Quality Adjusted Life Years (QALYs) [ Time Frame: Baseline until 12 months postoperatively ]
    Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires

  13. Costs per patient [ Time Frame: Baseline until 12 months postoperatively ]
    Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.

  14. Incremental cost-effectiveness ratios (ICERs): QALY [ Time Frame: Baseline until 12 months postoperatively ]
    Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)

  15. Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25 [ Time Frame: Baseline until 12 months postoperatively ]
    Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire

  16. Incremental cost-effectiveness ratios (ICERs): GQL-15 [ Time Frame: Baseline until 12 months postoperatively ]
    Calculated costs per clinically improved patient on the GQL-15 questionnaire

  17. Incremental cost-effectiveness ratios (ICERs): IOP [ Time Frame: Baseline until 12 months postoperatively ]
    Calculated costs per patient with clinically lowered IOP

  18. Budget impact [ Time Frame: Baseline until 12 months postoperatively ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931564


Contacts
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Contact: Lotte Scheres, MD 433877343 ext 0031 lotte.scheres@mumc.nl
Contact: Frank van den Biggelaar, PhD 43877344 ext 0031

Locations
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Netherlands
Maastricht University Medical Center+ (MUMC+) Recruiting
Maastricht, Limburg, Netherlands, 6229HX
Contact: L. Scheres, MD         
Principal Investigator: H.J.M. Beckers, MD, PhD         
Sub-Investigator: F.J.H.M. van den Biggelaar, PhD         
Sub-Investigator: L.M.J. Scheres, MD         
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Henny Beckers, MD, PhD Maastricht University Medical Center
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03931564    
Other Study ID Numbers: NL68964.068.19
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Glaucoma, Open-Angle
Trabeculectomy
Intraocular Pressure
Minimally invasive glaucoma surgery
InnFocus Microshunt
PRESERFLO Microshunt
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases