NCT01476644

Brief Summary

Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment worsens in subjects with glaucoma. Hypothesis 2: Changes in health-related quality of life are associated with changes in clinical measures of vision and performance-based measures of visual function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 30, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

4.8 years

First QC Date

October 31, 2011

Results QC Date

September 29, 2016

Last Update Submit

November 1, 2019

Conditions

GlaucomaQuality of Life

Keywords

Health related quality of lifeClinical measures of vision

Outcome Measures

Primary Outcomes (1)

  • Quality of Life With NEI VFQ-25

    National Eye Institute Visual Function-25 questionnaire (NEI VFQ-25) is a measurement of patients perception of their visually related quality of life. Patients select answers from multiple choice lists of responses. Values are re-coded and converted to a scale of 0 to 100 where 0 is extreme difficulty and 100 is no difficulty at all (or best quality of life). Data from visits 2 through 5.

    2 hours at each annual visit, visits 2 through 5

Secondary Outcomes (1)

  • Eye Comfort With MGSS

    2 hours at each annual visit, visits 2 through 5

Study Arms (1)

Glaucoma Patients

OTHER

Moderate glaucoma patients with a minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or pseudoexfoliation glaucoma were included to complete annual visits over a 4 year period. Each visit included (1) Clinical evaluation: a slit lamp examination, fundoscopy, intraocular pressure measurement, visual field examination, spectral domain optical coherence tomography, Pelli-Robson Contrast Sensitivity test and the Spaeth-Richman Contrast Sensitivity test; (2) a performance based measures: the Compressed Assessment of Ability Related to Vision; and (3) Subjective measures of vision-related quality of life (VRQoL) (the National Eye Institute Visual Functioning Questionnaire 25 and the Modified Glaucoma Symptom Scale).

Other: Clinical evaluationOther: Performance based measuresOther: Subjective measures of vision-related quality of life

Interventions

Clinical evaluationOTHER

Biomicroscopy (look at front of eye), ophthalmoscopy (look at back of eye), visual acuity, visual fields, intraocular pressure, spectral domain optical coherence tomography, Pelli-Robson and the Spaeth-Richman Contrast Sensitivity tests

Also known as: Ophthalmic examination
Glaucoma Patients
Performance based measuresOTHER

Compressed Assessment of Ability Related to Vision (CAARV) items include: 1) computerized motion detection; 2) recognizing facial expressions; 3) reading street signs; and 4) finding objects in a room

Also known as: Compressed Assessment of Ability Related to Vision
Glaucoma Patients
Subjective measures of vision-related quality of lifeOTHER

National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) includes a series of questions pertaining to vision or feelings about a vision condition and the Modified Glaucoma Symptom Scale (MGSS) includes a series of questions pertaining to eye comfort.

Also known as: Visual Functioning Questionnaire; Modified Glaucoma Symptom Scale
Glaucoma Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or exfoliation glaucoma
  • Disk Damage Likelihood Scale stages 5 through 8 with visual field loss
  • Age between 21 and 80 years
  • Able to understand and speak English

You may not qualify if:

  • Unlikely to be available for annual ocular examination and reassessment across a 4-year period
  • Neurological or musculoskeletal problems that would influence performance on activities of daily living
  • Cognitively impaired, as assessed by a face-to-face Mini-Mental State Examination
  • Incisional eye surgery within the past three months
  • Laser therapy within the previous month
  • Any cause for visual reduction other than glaucoma
  • Any medical condition which in the investigator's opinion would preclude the subject from providing reliable and valid data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (7)

  • Sun Y, Erdem E, Wizov S, Kayak N, Wei H, Spaeth GL. Quality of life measures in moderate glaucoma: study design and methodology. Abstract submitted, Association for Research in Vision and Ophthalmology, Dec 2012.

    BACKGROUND

  • Ekici F, Sun Y, Taranum S, Martinez P, Erdem E, Nayak N, Wizov SS, Waisbourd M, Spaeth GL. Relationship between baseline clinical characteristics and vision-related quality of life in patients with glaucoma. ARVO Poster 176-A0363 May 2014.

    BACKGROUND

  • Gogte P., Hark LA., Spaeth E., Richman J., Wizov SS., Waisbourd M., Spaeth GL. Contrast Sensitivity - A Meaningful Way to Assess Health Related Quality of Life and Ability to Perform Daily Activities in Glaucoma Patients. ARVO Poster 2097-A0004 May 2015.

    BACKGROUND

  • Waisbourd M., Gogte P., Richman J., Spaeth E., Dai Y., Wizov SS., Hark LA., Spaeth GL. Comparative Results with Regards to Humphrey Visual Fields and the SPARCS Contrast Sensitivity Test in Patients with Glaucoma. AOS meeting April 2015.

    BACKGROUND

  • Waisbourd M, Parker S, Ekici F, Martinez P, Murphy R, Scully K, Wizov SS, Hark LA, Spaeth GL. A prospective, longitudinal, observational cohort study examining how glaucoma affects quality of life and visually-related function over 4 years: design and methodology. BMC Ophthalmol. 2015 Aug 1;15:91. doi: 10.1186/s12886-015-0088-x.

    PMID: 26231376RESULT

  • Ekici F, Loh R, Waisbourd M, Sun Y, Martinez P, Nayak N, Wizov SS, Hegarty S, Hark LA, Spaeth GL. Relationships Between Measures of the Ability to Perform Vision-Related Activities, Vision-Related Quality of Life, and Clinical Findings in Patients With Glaucoma. JAMA Ophthalmol. 2015 Dec;133(12):1377-85. doi: 10.1001/jamaophthalmol.2015.3426.

    PMID: 26425961RESULT

  • Sun Y, Lin C, Waisbourd M, Ekici F, Erdem E, Wizov SS, Hark LA, Spaeth GL. The Impact of Visual Field Clusters on Performance-based Measures and Vision-Related Quality of Life in Patients With Glaucoma. Am J Ophthalmol. 2016 Mar;163:45-52. doi: 10.1016/j.ajo.2015.12.006. Epub 2015 Dec 14.

    PMID: 26701273RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
George L. Spaeth, MD
Organization
Wills Eye Hospital, Glaucoma Research Center
gspaeth@willseye.org
215-928-3123

Study Officials

  • George L Spaeth, MD

    Glaucoma Service, Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A prospective, longitudinal,observational cohort study to investigate how glaucoma affects patients' quality of life and visually-related function. Annual visits included (1) Clinical evaluation: a slit lamp examination, fundoscopy, intraocular pressure measurement, visual field examination, spectral domain optical coherence tomography, Pelli-Robson Contrast Sensitivity test and the Spaeth-Richman Contrast Sensitivity test; (2) a performance based measure: the Compressed Assessment of Ability Related to Vision; and (3) Subjective measures of vision-related quality of life (the National Eye Institute Visual Functioning Questionnaire 25 and the Modified Glaucoma Symptom Scale).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 22, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2016

Study Completion

June 1, 2017

Last Updated

November 15, 2019

Results First Posted

October 30, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)