Quality of Life Measures in Patients With Retinal Degeneration

Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of life. This study will involve collecting data from patients with IRD, but also collecting data from normal controls.

Study Overview

• Status: Completed
• Conditions: Retinal Degeneration
• Intervention / Treatment: Other: Questionnaire; Other: Computerised contrast sensitivity function test

Detailed Description

IRD presents a significant burden on the NHS as well as on the individual and families. IRDs are particularly difficult in a family situation due to guilt and other complex emotions related to inheritance patterns. Poorer mental health has been reported in patients with retinitis pigmentosa, manifesting in a range of ways including stress, depression and anxiety, particularly as the disease progresses. This is most probably caused by the uncertainty of the disease process and the progressive nature of the degeneration.

Recent work has reported that quality of life significantly deteriorates with a drop in visual field diameter of 20 degrees or a drop in visual acuity lower then LogMAR 0.3 (equivalent to 6/12). Contrast sensitivity is often used in conjunction with VA to assess visual capabilities. It is a measure of the ability to see reduced contrast and has a major impact on utility of vision. Relating contrast sensitivity function to quality of life will provide valuable information about whether this aspect of vision is a critical measure for patient health. This is especially important as novel treatments are being developed for the treatment of IRDs.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Oxford Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 patients with inherited retinal degeneration will be recruited from the outpatient clinic in the Oxford Eye Hospital. 30 healthy controls will be recruited from advertising around the OUH hospitals and the University of Oxford.

Description

Inclusion Criteria:

• Participant is willing & able to give informed consent for participation in the study.
• Male or female, aged 18 - 85.
• A clinical or genetic diagnosis of retinal degeneration or normal age and sex-matched controls without known retinal disease.
• Able to participate in visual function testing.

Exclusion Criteria:

• The participant may not enter the study if any of the following apply:

  • 1) they have a pre-existing amblyopia or squint;
  • 2) they have any other retinal problems that may confound the measures assessed.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with inherited retinal degeneration will answer two questionnaires and undergo a computerised contrast sensitivity function test.	Other: Questionnaire; The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).; Other: Computerised contrast sensitivity function test; This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.
Normal controls; Normal controls recruited by advertising will answer two questionnaires and undergo a computerised test that assess contrast sensitivity function.	Other: Questionnaire; The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).; Other: Computerised contrast sensitivity function test; This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of inherited retinal degeneration on quality of life measures.	This will be assessed by comparing questionnaire results between different inherited retinal degeneration types.This will be determined by using ANOVA testing to compare scores caused by different genetic mutations, allowing us to relate mutations causing central versus peripheral visual loss to the quality of life measures.	May 2016 to May 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of contrast sensitivity function on quality of life.	Contrast sensitivity function will be related to the questionnaire results using ANOVA testing & correlation analysis.	May 2016 to May 2017

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Jasleen K Jolly, MSc, University of Oxford

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Retina; Quality of Life Measures; Retinal Degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Eye Diseases, Hereditary; Retinal Degeneration
• Other Study ID Numbers: QoLMeasuresIRD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED