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

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Apr 29, 2019

Keywords

ClinConnect Summary

The SIGHT Study is looking at two different surgical options for treating primary open-angle glaucoma (POAG), a condition that can cause vision loss due to increased pressure in the eye. The standard treatment is called trabeculectomy, which is a more traditional surgery. However, this study is comparing it to a newer, less invasive option called the PRESERFLO™ Microshunt. This new device may lower eye pressure effectively while allowing for quicker recovery and fewer complications. The goal of the study is to find out if the Microshunt is not only effective but also cost-effective compared to the traditional surgery.

To participate in this trial, you must be an adult between 18 and 80 years old with uncontrolled glaucoma that has not responded well to medication. You should also have specific eye pressure measurements and need surgery. However, there are certain conditions that might prevent you from being eligible, such as having other types of glaucoma or previous eye surgeries. If you qualify and choose to participate, you can expect regular follow-up visits to monitor your condition and the outcomes of the surgery. This study is currently active but not recruiting new participants at this time.

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Eligibility 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.