Adaptation Time Required for the Optimisation of Maia Microperimetry Visual Field Testing

Retina; Change Clinical Trial

Official title:

Adaptation Time Required for the Optimisation of Maia Microperimetry Visual Field Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729818
• Other study ID #: DarkAdapt
• Status: Completed
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Microperimetry is a relatively new and extremely sensitive method of assessing visual function. It projects light stimuli onto a defined area of the retina to map retinal perceptual thresholds. Participants look at a focal point and press a button to indicate when they have seen a light stimulus. The stimuli vary in intensity to find the participant's visual sensitivity.

Microperimetry is carried out in low light conditions. Before testing, participants must adapt to the low light conditions in a process called 'dark adaptation.' Currently there is no consensus on the optimal time needed for dark adaptation. Investigators know that visual sensitivity differs in differing light conditions. Failing to sufficiently dark-adapt may therefore adversely affect test results.

The aim of this study is to establish the optimal length of dark adaptation for microperimetry performance in healthy volunteers. On day 1, participants will undergo training field tests to reduce a learning effect affecting the results. Tests will then be performed following 5 mins adaptation, 10 mins adaptation and 30mins adaptation, On day 2, participants will perform testing following no adaptation time, 15 mins adaptation, and 20 mins adaptation. Statistics will be used to determine the effect of adaptation time on average threshold measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Male or female.

• Age 18 - 60 years.

• Best corrected visual acuity of at least Logmar 0.1 in right eye.

• Able to tolerate physical requirements of microperimetry testing i.e. able to sit still at the microperimeter in dark environment and indicate when a light stimulus has been seen using the provided button.

Exclusion Criteria:

• Any co-existing ocular pathology, either pre-existing or identified on initial ocular examination, not including refractive error or previous cataract surgery

Related Conditions & MeSH terms

• Retina; Change

Locations

Country	Name	City	State
United Kingdom	Nuffield Laboratory of Ophthalmology	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Han RC, Gray JM, Han J, Maclaren RE, Jolly JK. Optimisation of dark adaptation time required for mesopic microperimetry. Br J Ophthalmol. 2018 Sep 29. pii: bjophthalmol-2018-312253. doi: 10.1136/bjophthalmol-2018-312253. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average threshold of tests following different dark adaptation periods will be compared.	The average threshold for each test is detailed on the microperimetry printout and is measured in dB. This will be measured by testing following each time interval specified.	Different time intervals for adaptation prior to testing; 0 minutes, 5, 10, 15, 20 and 30 minutes on day 1 and day 2.
Secondary	Change in fixation stability, as defined by the area in which 95% of the fixation points for any specific test fall, following different dark adaptation periods will be compared.	The fixation stability for each test is detailed on the microperimetry printout and is measured in degrees for the area covering 95% of the fixation points. This will be measured by testing following each time interval specified.	Different time intervals for adaptation prior to testing; 0 minutes, 5, 10, 15, 20 and 30 minutes on day 1 and day 2

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