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

Last updated: March 18, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

PRESERFLO Microshunt implantation

Trabeculectomy

Clinical Study ID

NCT03931564
NL68964.068.19
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult Caucasian patients aged between 18 and 80 years old with uncontrolled primaryopen angle glaucoma on (maximum tolerated) medical therapy and/or progression ofvisual field loss, an IOP ≥18 and ≤40 mmHg, and an indication for primary glaucomasurgery (trabeculectomy) are suitable for inclusion.

Exclusion

Exclusion Criteria:

  1. Patient unwilling or unable to give informed consent, unwilling to acceptrandomization or inability to complete follow-up (e.g. hospital visits) or comply withstudy 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 cornealcataract 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 correctedvis-ual acuity <0.6 and/or a visual field loss within the central 10 degrees (withexception of a superior altitudinal defect).
  5. Any ocular comorbidities that could affect the visual field. (e.g. diabeticretinopathy, proliferative retinopathy, aphakia, degenerative visual disorder notassociated with glaucoma)
  6. Chronic or recurrent uveitis.
  7. Need for glaucoma surgery combined with other ocular procedures or anticipated needfor additional ocular surgery.
  8. Anatomical factors that increase the risk of complicated surgery (due to previoustrauma, anatomical abnormalities, anterior synechiae or previous cyclodestructiveprocedure).
  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 foran indication other than the surgery within 3 months of the procedure (this wouldnot include the use of inhaled or dermatologic steroids), chemotherapy within 6months of the procedure.
  • Iodine allergy
  • Unwilling to discontinue contact lens after surgery
  1. Contraindication or allergy to mitomycin C.
  2. Any contraindication to tube placement (e.g. shallow anterior chamber, insufficientendothelial cell density).
  3. Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
  4. Prior ocular laser treatment within 3 months of the surgery, increasing the risk ofin-flammation in the eye.
  5. Corneal thickness <450um or >620microns.
  6. Conditions associated with elevated episcleral venous pressure such as active thyroidorbitopathy.
  7. Among patients in whom both eyes are eligible only the first eye is undergoingsurgical treatment is enrolled in the study.
  8. Participation in another clinical study.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: PRESERFLO Microshunt implantation
Phase:
Study Start date:
February 01, 2020
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Maastricht University Medical Center+ (MUMC+)

    Maastricht, Limburg 6229HX
    Netherlands

    Site Not Available

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