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Night Myopia and Dark Focus of Accommodation

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ClinicalTrials.gov Identifier: NCT03358550
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Philipp Hessler, University of Applied Sciences Jena

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dark Focus of Accommodation Diagnostic Test: Accommodation Measurement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Sequence of tests was randomized. It is no multi-arm study.
Primary Purpose: Basic Science
Official Title: Influence of an Imaginary Target on the State of Accommodation Under Scotopic Conditions
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Accommodation in scotopic luminance Diagnostic Test: Accommodation Measurement
Accommodation was measured for different distances and light conditions.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358550


Locations
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Germany
University of Applied Sciences
Jena, TH, Germany, 07745
Sponsors and Collaborators
University of Applied Sciences Jena
Investigators
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Principal Investigator: Philipp Hessler, M.Sc. University of Applied Sciences Jena
More Information
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Responsible Party: Philipp Hessler, Principal Investigator, University of Applied Sciences Jena
ClinicalTrials.gov Identifier: NCT03358550    
Other Study ID Numbers: UASJena
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipp Hessler, University of Applied Sciences Jena:
accommodation
dark focus
night myopia