Hydrus microstent implantation to improve quality of life in glaucoma patients
Hydrus Microstent as a Quality of Life Consideration
InSight Vision Center Medical Group, Inc · NCT05955118
This study tests if putting in a Hydrus microstent during cataract surgery can help improve the quality of life for people with open angle glaucoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | InSight Vision Center Medical Group, Inc (other) |
| Locations | 1 site (Fresno, California) |
| Trial ID | NCT05955118 on ClinicalTrials.gov |
What this trial studies
This observational study investigates whether the implantation of the Hydrus microstent during cataract surgery can enhance the quality of life for patients with open angle glaucoma. It employs a prospective, interventional single-arm design, focusing on patient-reported outcomes through the Glaucoma Symptom Scale (GSS) and ocular surface disease assessments before and after the procedure. Additionally, the study aims to identify various quality of life factors that influence patients' decisions to undergo Hydrus implantation.
Who should consider this trial
Good fit: Ideal candidates include individuals with mild to moderate open angle glaucoma who are also undergoing cataract surgery and currently using ocular hypotensive medications.
Not a fit: Patients with secondary glaucoma, significant ocular conditions, or those with severe systemic diseases that affect quality of life may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients suffering from open angle glaucoma.
How similar studies have performed: While this approach is relatively novel, previous studies on microstent implantation have shown promising results in improving intraocular pressure and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus Microstent * Current treatment with one or more ocular hypotensive medication * Corneal thickness between 470 to 610µm * Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively Exclusion Criteria: * Clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma) * corneal opacity or angle abnormalities that make visualizing the angle difficult * Past ocular surgery * History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy) * Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts
Where this trial is running
Fresno, California
- Terri Smith — Fresno, California, United States (RECRUITING)
Study contacts
- Study coordinator: Terri Smith
- Email: tsmith@insightvisioncenter.com
- Phone: 5594495050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Open Angle Glaucoma