NCT07303257 Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options
| NCT ID | NCT07303257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Glaucoma Eye |
| Study Type | OBSERVATIONAL |
| Enrollment | 132 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 132 participants in total. It began in 2026-02-23 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Glaucoma surgery currently relies on a wide therapeutic arsenal, ranging from conventional filtering surgeries to minimally invasive glaucoma surgery (MIGS). These techniques offer distinct efficacy and safety profiles, allowing tailored management across a broad spectrum of patients. Traditionally, surgical success has been evaluated using objective clinical outcomes, such as intraocular pressure (IOP) reduction and decreased reliance on topical treatments. However, the shift toward patient-centered medicine now requires consideration of the patient's perspective, including their subjective experience and the impact of treatment on quality of life. In this context, quality-of-life assessment has become a key component, promoting therapeutic alliance and patient adherence to care pathways. Despite its importance, few studies have evaluated and compared quality of life after glaucoma surgery using comparable surgical techniques. Furthermore, to our knowledge, no study has specifically assessed the independent effect of postoperative follow-up on quality of life after filtering surgery with a bleb. Given that postoperative management can be prolonged and demanding, it may significantly influence patients' perceptions of surgical outcomes and overall well-being. This study aims to address these gaps by providing a more comprehensive evaluation of the impact of glaucoma surgery beyond traditional clinical outcomes. It may represent a first step toward the development of a more appropriate assessment tool that incorporates the realities of postoperative follow-up and the specific experiences of patients undergoing filtering surgery. The study is based on the following hypotheses: filtering glaucoma surgery preserves patients' quality of life, with a stable NEI VFQ-25 score at six months postoperatively; postoperative quality of life may be influenced by the patient's postoperative care pathway; and quality-of-life scores remain correlated with objective clinical parameters, including intraocular pressure, visual acuity, medical treatment burden, and visual field damage.
Eligibility Criteria
Inclusion Criteria: * Patient aged ≥ 18 years with an indication for glaucoma surgical treatment * Eligible surgical procedures: Preserflo™ MicroShunt with mitomycin C, Trabeculectomy with mitomycin C or non-penetrating deep sclerectomy with mitomycin C * Unilateral or bilateral glaucoma, open-angle or angle-closure, at early, moderate, or advanced stages * Pseudoxexfoliative or pigmentary glaucoma * Secondary glaucoma, including: uveitic glaucoma, Steroid-induced glaucoma, traumatic glaucoma * Written informed consent obtained prior to study participation Exclusion Criteria: * Congenital glaucoma * Refractory glaucoma with a history of multiple previous surgeries * Ophthalmologic surgery within 6 months prior to inclusion * Severe visual co-morbidities (age-related macular degeneration, severe diabetic retinopathy, retinal degeneration, or similar conditions) * Expected difficulty with follow-up including poor anticipated compliance, planned travel or prolonged absence during the follow-up period * Illiteracy, inability to speak French or impaired cognitive capacity preventing adequate understanding of the study * Patients with a significant pre-existing impairment in quality of life attributable to a progressive physical illness or a neuropsychiatric disorder. * Patients under curatorship or guardianship * Pregnant women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07303257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07303257 currently recruiting?
Yes, NCT07303257 is actively recruiting participants. Contact the research team at victor.vermot-desroches@chu-lyon.fr for enrollment information.
Where is the NCT07303257 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT07303257 clinical trial?
NCT07303257 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 132 participants.