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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02669-40 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult with open-angle/angle-closure or exfoliative or pigmentary glaucoma and a surgical indication | Adult patient with different stage of glaucoma and a surgical indication for sclerectomy + Mitomycin, PRESERFLO + Mitomycin, or trabeculectomy + Mitomycin. . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25). | Other | The NEI-VFQ-25 questionnaire, translated into French and validated by the French National Authority for Health (HAS), is used to assess quality of life related to visual function. This questionnaire includes 25 items divided into 11 subdomains assessing vision-related functioning and 1 subdomain assessing general health status (see appendix for the detailed list). The composite score ranges from 0 to 100, with lower scores indicating a poorer perceived level of health and visual functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25). | To evaluate, in adult patients undergoing glaucoma surgery, the change in NEI-VFQ 25 quality of life score between the pre-operative period and 6ᵉ months post-operatively, regardless of the surgical technique used. | Pre-operative period and 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of NEI-VFQ-25 scores between surgical techniques | Comparison of postoperative vision-related quality-of-life outcomes across the different glaucoma surgical techniques, assessed using the global NEI-VFQ-25 score at 6 months after surgery. The questionnaire yields a total score ranging from 0 to 100, with higher scores corresponding to a positive outcome. It will be self-completed by the patient, with an estimated completion time of approximately 15 minutes. No changes will be made to the department's standard postoperative follow-up protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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Glaucoma patients aged ≥ 18 years, operated on using one of the following 3 types of surgery: Trabeculectomy , Deep non-perforating sclerectomy or Preserflo
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor VERMOT-DESROCHES, MD | Contact | 426109431 | +33 | victor.vermot-desroches@chu-lyon.fr |
| Christelle SZATANEK | Contact | 426732724 | +33 | christelle.szatanek@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon | Recruiting | Lyon | 69317 | France |
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| 6 months postoperatively (M6) |
| Correlation between NEI-VFQ-25 score and postoperative clinical parameters | To assess the relationship between vision-related quality-of-life outcomes, measured by the NEI-VFQ-25 score, and objective postoperative clinical results. | Postoperative visits at Month 3 (M3) |
| Correlation between NEI-VFQ-25 score and postoperative clinical parameters | To assess the relationship between vision-related quality-of-life outcomes, measured by the NEI-VFQ-25 score, and objective postoperative clinical results. | Postoperative visits at Month 6 (M6) |
| Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 3 months | To evaluate the effect of postoperative management-including adjunctive procedures, number of follow-up visits, and the occurrence of complications-on the NEI-VFQ-25 quality-of-life score in patients undergoing glaucoma surgery with a filtering bleb. | Prospective collection of postoperative follow-up data through Month 3 (M3) |
| Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 6 months | To evaluate the effect of postoperative management-including adjunctive procedures, number of follow-up visits, and the occurrence of complications-on the NEI-VFQ-25 quality-of-life score in patients undergoing glaucoma surgery with a filtering bleb. | Prospective collection of postoperative follow-up data through Month 6 (M6) |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D015812 | Glaucoma, Angle-Closure |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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