GlaucomaGR-QoLNCT07510087
Glaucoma Related Quality of Life
An observational study of Glaucoma, run by Marc Toeteberg-Harms at 1 site in United States.
Trial summary
Subjects with a diagnosis of glaucoma will be handed out different quality of life related questionnaires and their score will be evaluated at baseline and 3-6 months after treatment or surgery was initiated/performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- GQL-15, Glaucoma Symptom Scale and NEI Vision Function Questionnaire
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to 30 May 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: any patient with a diagnosis of glaucoma treated or evaluated for glaucoma at the Dept. of Ophthalmology \& Visual Sciences, University of Iowa, Iowa City, IA, USA
Who may be able to join
- diagnosis of glaucoma (open- as well as closed-angle glaucoma, primary and secondary glaucomas)
- 18 years of age or older with no upper limit
- male and female subjects
Who cannot join
- absence of a diagnosis of glaucoma
- less than 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa, Dept. of Ophthalmology & Visual Sciences
Iowa City, Iowa, 52242
Marc Toeteberg-Harms, MD, +1 319 356 3938, marc-toeteberg-harms@uiowa.edu
Helen Gomez, +1 319 356 3938, helen-gomez@uiowa.edu
About this study
Subjects with a diagnosis of glaucoma will be handed out different quality of life related questionnaires and their score will be evaluated at baseline and 3-6 months after treatment or surgery was initiated/performed.
- Conditions
- Glaucoma
- Being tested
- GQL-15, Glaucoma Symptom Scale, NEI Vision Function Questionnaire, Ocular Surface Disease Index
- Keywords
- glaucoma, quality of life
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GQL-15Other
GQL-15 questionnaire
Glaucoma Symptom ScaleOther
GSS questionnaire
NEI Vision Function QuestionnaireOther
Vision function questionnaire
Ocular Surface Disease IndexOther
OSDI questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Study Arm (glaucoma) | subjects with a diagnosis of glaucoma Receives: Other: GQL-15; Other: Glaucoma Symptom Scale; Other: NEI Vision Function Questionnaire; Other: Ocular Surface Disease Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
The OSDI© is assessed on a scale of 0 to 4, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Measured: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
Glaucoma Symptom Scale (GSS)
The Glaucoma Symptom Scale (GSS; Lee et al., 1998) was developed as a brief symptom survey specific for persons with glaucoma. The GSS consists of a 10-item scale developed from a modified version of a symptom checklist that address ocular complaints, some of a nonvisual nature and some of a visual nature, common to patients with glaucoma. Items are scored from 0 to 100, where 100 represents the absence of symptoms and 0 represents severe, bothersome symptoms.
Measured: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
National Eye Institute Visual Function Questionaire (NEI VFQ)
Vision-specific instrument designed to measure vision-related quality of life (VRQoL) in adults, incorporating body, activity, and participation content according to the WHO ICF Framework in order to measure the effects of a variety of ocular conditions on daily functioning and QOL. It was originally designed as a 51-point questionnaire and is currently available in both self-administered and interview-based formats. The raw scores are converted to a 0-100 scale; after reverse scoring, a high score (100) indicates better vision-specific quality of life, while a low score (0) indicates poor function.
Measured: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
Glaucoma Quality of Life-15 (GQL-15)
The Glaucoma Quality of Life-15 (GQL-15) is a validated 15-item, self-report questionnaire used to measure visual disability and quality of life (QoL) in glaucoma patients. It covers four key areas-peripheral vision, central/near vision, glare/dark adaptation, and outdoor mobility-using a 5-point scale (1=no difficulty to 5=severe difficulty).
Measured: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start30 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc Toeteberg-Harms
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Toeteberg-Harms, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510087
- Sponsor's protocol ID
- 202407431
- Acronym
- GR-QoL
- Status last verified
- Apr 2026
- First submitted
- 30 Dec 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be stored anonymously without patient identifier. It can be shared on a case by case decision.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Related Quality of Life
- ClinicalTrials.gov ID
- NCT07510087
- Acronym / sponsor ID
- GR-QoL / 202407431
- Conditions
- Glaucoma
- Keywords
- glaucoma, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Marc Toeteberg-HarmsUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 3 Apr 2026 (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.
Subjects with a diagnosis of glaucoma will be handed out different quality of life related questionnaires and their score will be evaluated at baseline and 3-6 months after treatment or surgery was initiated/performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm (glaucoma) | – | Other: GQL-15, Other: Glaucoma Symptom Scale, Other: NEI Vision Function Questionnaire, Other: Ocular Surface Disease Indexsubjects with a diagnosis of glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient with a diagnosis of glaucoma treated or evaluated for glaucoma at the Dept. of Ophthalmology \& Visual Sciences, University of Iowa, Iowa City, IA, USA
Key inclusion criteria (3 listed)
- diagnosis of glaucoma (open- as well as closed-angle glaucoma, primary and secondary glaucomas)
- 18 years of age or older with no upper limit
- male and female subjects
Key exclusion criteria (2 listed)
- absence of a diagnosis of glaucoma
- less than 18 years of age
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 |
|---|---|---|
| GQL-15GQL-15 questionnaire | Other | Study Arm (glaucoma) |
| Glaucoma Symptom ScaleGSS questionnaire | Other | Study Arm (glaucoma) |
| NEI Vision Function QuestionnaireVision function questionnaire | Other | Study Arm (glaucoma) |
| Ocular Surface Disease IndexOSDI questionnaire | Other | Study Arm (glaucoma) |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
The OSDI© is assessed on a scale of 0 to 4, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Glaucoma Symptom Scale (GSS)
Time frame: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
The Glaucoma Symptom Scale (GSS; Lee et al., 1998) was developed as a brief symptom survey specific for persons with glaucoma. The GSS consists of a 10-item scale developed from a modified version of a symptom checklist that address ocular complaints, some of a nonvisual nature and some of a visual nature, common to patients with glaucoma. Items are scored from 0 to 100, where 100 represents the absence of symptoms and 0 represents severe, bothersome symptoms.
National Eye Institute Visual Function Questionaire (NEI VFQ)
Time frame: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
Vision-specific instrument designed to measure vision-related quality of life (VRQoL) in adults, incorporating body, activity, and participation content according to the WHO ICF Framework in order to measure the effects of a variety of ocular conditions on daily functioning and QOL. It was originally designed as a 51-point questionnaire and is currently available in both self-administered and interview-based formats. The raw scores are converted to a 0-100 scale; after reverse scoring, a high score (100) indicates better vision-specific quality of life, while a low score (0) indicates poor function.
Glaucoma Quality of Life-15 (GQL-15)
Time frame: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
The Glaucoma Quality of Life-15 (GQL-15) is a validated 15-item, self-report questionnaire used to measure visual disability and quality of life (QoL) in glaucoma patients. It covers four key areas-peripheral vision, central/near vision, glare/dark adaptation, and outdoor mobility-using a 5-point scale (1=no difficulty to 5=severe difficulty).
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided. data will be stored anonymously without patient identifier. It can be shared on a case by case decision.
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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, run by Marc Toeteberg-Harms at 1 site in United States.
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 3 inclusion and 2 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 6 Apr 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 United States. 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 Marc Toeteberg-Harms, MD (+1 319 356 3938, marc-toeteberg-harms@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.). The study lists 4 primary outcomes in all. 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 6 Apr 2026.