Wearable Dark-adaptometer in Normal Adult Healthy Volunteers

NCT ID: NCT02674425

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-07-31

Brief Summary

Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high cost, lack of easy portability, need of trained staff and a totally dark room to be operated, arbitrary testing procedures, associated time waste in clinic and patient burden to mention a few. Consequently, dark adaptometers are not routinely used as clinical tools for retinal diagnosis and monitoring despite the inherent benefits over other visual electrophysiology equipment such as the ERG system, whose cost and features may often be surplus to optometrists' requirements.

This trial will assess the dark-adaptometry testing performance of a novel light-emitting system by generating full dark-adaptation threshold functions in normal adult healthy volunteers.

The novel system has been proposed to overcome the issues associated with current instrumentation; it is semi-automatic and easy to use without the need of any skilled operator.

It is envisaged that this system could spread the practice of dark-adaptometry testing and its adoption by high-street optometrists. This will allow diagnosing a number of retinal pathologies more quickly and more reliably that, faced with an ageing population, represents a major asset to the Health Community and the NHS.

This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of 18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry testing 3 times on separate days within 3 weeks.

Testing will clarify whether by using the novel system it is possible to reproduce state-of-the-art threshold measurements as good or better than those produced by commercially-available dark-adaptometers. Threshold measurements in the elderly will be compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis contributions. Data variability and system usability will be also assessed.

Detailed Description

All details elsewhere in the documentation

Conditions

Photoreceptor Sensitivity Thresholds

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Young adults (18-40)

Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.

Dark Adaptometer

Intervention Type: DEVICE

Older adults (50-70)

Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.

Dark Adaptometer

Intervention Type: DEVICE

Interventions

Dark Adaptometer

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Refractive error: ≤ ±5 dioptres spherical (myopia/hyperopia) equivalent; ≤ 3 dioptres cylinder (astigmatism) equivalent.

Exclusion Criteria

• Subjects not in age range and/or unable to fully understand the informed consent and/or unable to comply with study procedures.
• Self-reported history of depression, lack of sleep, psychiatric disorders, or neurological diseases such as Alzheimer's and Parkinson's disease.
• Self-reported history of diabetes, stroke, or multiple sclerosis.
• Self-reported hypovitaminosis A, alcoholism, liver or intestinal disease, malabsorption, protein calorie malnutrition, or sickle cell anaemia.
• Use of psychoactive drugs (including lithium salts for mood stabilisation).
• Use of dietary intake of ascorbic acid, vitamin A, B, E or other antioxidant supplements in the last two weeks.
• Recurrent practice of activities that expose the retina to ultra-violet radiation such as sailing, fishing, sunbathing or tanning saloons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel L Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

University of Liverpool

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UoL001185

Identifier Type: -

Identifier Source: org_study_id