Electroretinography: Investigation of a Protocol Change

NCT03275441 | Unknown

• 1 other identifier: GN17OP146
• Study Type: observational
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened and still produce the same diagnostic results. The results of this study may allow test times to be reduced which will have benefits such as improved patient compliance during shorter testing and increased clinic efficiency.

Conditions

Dark-adapted ERG

Keywords

electroretinogram; ERG; dark-adaptation; ophthalmology; electrophysiology; ISCEV; electroretinography; scotopic

Outcome Measures

Primary Outcomes (2)

• Rate of classification for ERG following 10 minute dark adaptation

  The rate of classification (normal vs abnormal) for testing conducted after 10 minutes of dark adaptation.

  (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation

• Rate of classification (normal vs abnormal) for ERG following 20 minute dark adaptation

  The rate of classification (normal vs abnormal) for testing conducted after 20 minutes of dark adaptation.

  (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation

Secondary Outcomes (6)

• Response amplitude after 10 minutes

  (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation

• Response amplitude after 20 minutes

  (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation

• Response timing

  (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation

• Response timing

  (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation

• Response variability

  (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation

Study Arms (1)

Adult patients

Adult patients attending hospital for clinical visual electrophysiology.

Diagnostic Test: Electroretinography

Interventions

Electroretinography DIAGNOSTIC_TEST

An additional electroretinogram performed after 10 minutes of dark adaptation.

Adult patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient population attending hospital for routine clinical electroretinography.

You may qualify if:

• Patients referred to the adult visual electrophysiology service regardless of clinical condition, and who require dark-adapted electroretinography as part of their appointment
• Male or female
• All ethnicities

You may not qualify if:

• Patients less than 18 years old
• Patients who might have difficulties understanding the participant information provided (for example, those patients requiring a translator, or who have learning difficulties)
• Patients with photosensitive epilepsy
• Patients appointed for clinical testing urgently, or via telephone, who will not have had an opportunity to receive and review the participant information sheet ahead of the clinical appointment.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

MeSH Terms

Interventions

Electroretinography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Ruth Hamilton, PhD

  NHS Greater Glasgow & Clyde

  STUDY DIRECTOR

• Kirsten Graham, MSc

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

• Richard Hagan, PhD

  NHS Royal Liverpool University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Hamilton, PhD

CONTACT

01414524217; ruth.hamilton@glasgow.ac.uk

Kirsten Graham, MSc

CONTACT

01412112758; kirsten.graham@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: September 7, 2017
• Study Start: October 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share