Glaucoma EyeG-SCOPENCT07303257
Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options
An observational study of Glaucoma Eye and Open-angle Glaucoma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma Eye, Open-angle Glaucoma, Closed-Angle Glaucoma
- What is being tested?
- NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma patients aged ≥ 18 years, operated on using one of the following 3 types of surgery: Trabeculectomy , Deep non-perforating sclerectomy or Preserflo
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon
Lyon, 69317
Victor VERMOT-DESROCHES, MD, 426109431 ext. +33, victor.vermot-desroches@chu-lyon.fr
Victor VERMOT-DESROCHES, MD
About this study
Official title: Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options - G-SCOPE (Glaucoma Surgery - Comparative Patient Evaluation)
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.
Read more
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.
- Conditions
- Glaucoma Eye, Open-angle Glaucoma, Closed-Angle Glaucoma, Pseudo Exfoliative Syndrome, Pigmentary Glaucoma
- Being tested
- NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
- Keywords
- Glaucoma, Trabeculectomy, Sclerectomy, PreserFlo® Micro Shunt, Quality of life, Glaucome Surgery, MIGS, NEI-VFQ 25 (National Eye Institute- Visual Function Questionnaire 25)
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
. Receives: Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative period and 6 months after intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Prospective collection of postoperative follow-up data through Month 6 (M6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start23 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma EyeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303257
- Sponsor's protocol ID
- 69HCL25_0896
- Other IDs
- 2025-A02669-40
- Acronym
- G-SCOPE
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options - G-SCOPE (Glaucoma Surgery - Comparative Patient Evaluation)
- ClinicalTrials.gov ID
- NCT07303257
- Acronym / sponsor ID
- G-SCOPE / 69HCL25_0896
- Conditions
- Glaucoma Eye, Open-angle Glaucoma, Closed-Angle Glaucoma, Pseudo Exfoliative Syndrome, Pigmentary Glaucoma
- Keywords
- Glaucoma, Trabeculectomy, Sclerectomy, PreserFlo® Micro Shunt, Quality of life, Glaucome Surgery, MIGS, NEI-VFQ 25 (National Eye Institute- Visual Function Questionnaire 25)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult with open-angle/angle-closure or exfoliative or pigmentary glaucoma and a surgical indication | – | Other: NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).Adult patient with different stage of glaucoma and a surgical indication for sclerectomy + Mitomycin, PRESERFLO + Mitomycin, or trabeculectomy + Mitomycin. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients aged ≥ 18 years, operated on using one of the following 3 types of surgery: Trabeculectomy , Deep non-perforating sclerectomy or Preserflo
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Adult with open-angle/angle-closure or exfoliative or pigmentary glaucoma and a surgical indication |
Primary outcome
Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
Time frame: Pre-operative period and 6 months after intervention
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.
5 secondary outcomes
Comparison of NEI-VFQ-25 scores between surgical techniques
Time frame: 6 months postoperatively (M6)
Correlation between NEI-VFQ-25 score and postoperative clinical parameters
Time frame: Postoperative visits at Month 3 (M3)
Correlation between NEI-VFQ-25 score and postoperative clinical parameters
Time frame: Postoperative visits at Month 6 (M6)
Impact of postoperative follow-up on NEI-VFQ-25 quality-of-life scores at 3 months
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
Time frame: Prospective collection of postoperative follow-up data through Month 6 (M6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Eye and Open-angle Glaucoma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor VERMOT-DESROCHES, MD (426109431 ext. +33, victor.vermot-desroches@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25). (time frame: Pre-operative period and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.