An observational study in Glaucoma Eye, Open-angle Glaucoma and Closed-Angle Glaucoma, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Hospices Civils de Lyon · Observational
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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 132 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patient with different stage of glaucoma and a surgical indication for sclerectomy + Mitomycin, PRESERFLO + Mitomycin, or trabeculectomy + Mitomycin. .
Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
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.
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.
Time frame: Pre-operative period and 6 months after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Prospective collection of postoperative follow-up data through Month 6 (M6)
Plan to share: No
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