Clinical trial NCT02814435: Quality of Life Measures in Patients With Retinal Degeneration
Official title: Quality of Life Measures in Patients With Retinal Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Degeneration
Keywords: Retina
Retinal Degeneration
Quality of Life Measures
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of inherited retinal degeneration on quality of life measures.
timeFrame: May 2016 to May 2017
Secondary outcomes:
measure: Effect of contrast sensitivity function on quality of life.
timeFrame: May 2016 to May 2017
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital
Study officials:
affiliation: University of Oxford
name: Jasleen K Jolly, MSc
role: PRINCIPAL_INVESTIGATOR
References: