Glaucoma Related Quality of Life (GR-QoL)

April 3, 2026 updated by: Marc Toeteberg-Harms
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa, Dept. of Ophthalmology & Visual Sciences
        • Principal Investigator:
          • Marc Toeteberg-Harms, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion:

  • 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

Exclusion:

  • absence of a diagnosis of glaucoma
  • less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Arm (glaucoma)
subjects with a diagnosis of glaucoma
Other: GQL-15
GQL-15 questionnaire
Other: Glaucoma Symptom Scale
GSS questionnaire
Other: NEI Vision Function Questionnaire
Vision function questionnaire
Other: Ocular Surface Disease Index
OSDI questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.
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.
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)
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.
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)
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).
At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marc Toeteberg-Harms

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202407431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data will be stored anonymously without patient identifier. It can be shared on a case by case decision.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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