- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03358550
Night Myopia and Dark Focus of Accommodation
November 29, 2017 updated by: Philipp Hessler, University of Applied Sciences Jena
Influence of an Imaginary Target on the State of Accommodation Under Scotopic Conditions
Shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia.
Previous studies with laser optometers quantified the dark focus of accommodation up to 3 D.
In addition to the measurement of dark focus, the aim of this study was to investigate the influence of an imaginary target at finite distances on the state of accommodation at scotopic luminance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Accommodation was measured by using an open-field autorefractor (WAM 5500, GRAND SEIKO).
Full corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this randomized, cross-sectional study.
Accommodation measurements in photopic luminance were taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m.
At scotopic luminance, dark focus of accommodation was examined directly after darkening and after 10 min of dark adaptation.
After adaptation, subjects had to visualize imaginary targets in the four distances while accommodation was measured.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
TH
-
Jena, TH, Germany, 07745
- University of applied sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 39 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18 - 44
- visual acuity at least 0.8 (5/6)
Exclusion Criteria:
- medication with an impact on the visual system
- visual disease or disease with an impact on the visual system
- pregnancy or other hormonal variances
- drug usage
- overfatigue at the period of investigation
- mental handicap
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Accommodation in scotopic luminance
|
Accommodation was measured for different distances and light conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shift of accommodation in scotopic luminance (Dark focus)
Time Frame: Baseline only
|
Accommodative shift in scotopic luminance compared to photopic luminance for empty field (dark focus of accommodation)
|
Baseline only
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of accommodation for 2 m target
Time Frame: Baseline only
|
Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 2 m
|
Baseline only
|
Difference of accommodation for 1 m target
Time Frame: Baseline only
|
Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 1 m
|
Baseline only
|
Difference of accommodation for 0.5 m target
Time Frame: Baseline only
|
Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 0.5 m
|
Baseline only
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Philipp Hessler, M.Sc., University of Applied Sciences Jena
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 2, 2017
Primary Completion (ACTUAL)
March 23, 2017
Study Completion (ACTUAL)
March 23, 2017
Study Registration Dates
First Submitted
November 26, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (ACTUAL)
November 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2017
Last Update Submitted That Met QC Criteria
November 29, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UASJena
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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