Glaucoma Related Quality of Life (GR-QoL)

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: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Other: GQL-15; Other: Glaucoma Symptom Scale; Other: NEI Vision Function Questionnaire; Other: Ocular Surface Disease Index

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Marc Toeteberg-Harms, MD; Phone Number: +1 319 356 3938; Email: marc-toeteberg-harms@uiowa.edu
• Study Contact Backup: Name: Helen Gomez Study Coordinator; Phone Number: +1 319 356 3938; Email: helen-gomez@uiowa.edu

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: Marc Toeteberg-Harms, MD; Phone Number: +1 319 356 3938; Email: marc-toeteberg-harms@uiowa.edu
      • Contact: Helen Gomez; Phone Number: +1 319 356 3938; Email: helen-gomez@uiowa.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	At baseline and 3-6 months after glaucoma treatment (i.e. drops, SLT, or surgery) was initiated/performed.

Collaborators and Investigators

• Sponsor: Marc Toeteberg-Harms

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID 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