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

NCT03931564 | Unknown

• 1 other identifier: NL68964.068.19
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Open-angle Glaucoma

Keywords

Glaucoma, Open-Angle; Trabeculectomy; Intraocular Pressure; Minimally invasive glaucoma surgery; InnFocus Microshunt; PRESERFLO Microshunt

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  The intraocular pressure is measured using a Goldmann applanation tonometer

  12 months postoperatively

Secondary Outcomes (18)

• Visual acuity

  baseline, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively

• Glaucoma medical therapy

  at baseline and 1 day, 1 week, 4 weeks, 3, 6, 9 and 12 months postoperatively

• Failure rate

  3, 6, 9 and 12 months postoperatively

• Complications

  Intraoperatively and up to 12 months after the surgery.

• Reinterventions

  Measured up to 12 months after the surgery.

Study Arms (2)

PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))

ACTIVE COMPARATOR

The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS).

Procedure: PRESERFLO Microshunt implantation

Trabeculectomy

ACTIVE COMPARATOR

The usual care/control group will undergo a standard trabeculectomy.

Procedure: Trabeculectomy

Interventions

PRESERFLO Microshunt implantation PROCEDURE

The intervention consists of the microshunt implantation augmented with mitomycin C application.

Also known as: InnFocus Microshunt implantation

PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))

Trabeculectomy PROCEDURE

The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.

Trabeculectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht University Medical Center+ (MUMC+)

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36721130 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Henny Beckers, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 30, 2019
• Study Start: February 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2023-10

Locations

NL (1)