Clinical Trial: Toric Eye Strain and Stability Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.

Detailed Summary:
Sponsor: Johnson & Johnson Vision Care, Inc.

Current Primary Outcome:

  • Objective Comfort Assessed by Electromyography(EMG) [ Time Frame: 1 week ]
    Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.
  • Visual Comfort [ Time Frame: 1-week follow-up ]
    The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry,

    Original Primary Outcome: Objective Comfort [ Time Frame: 1 week ]

    Measured by electromyography


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Monocular high contrast visual performance on LogMAR scale [ Time Frame: 1 week ]
    • Monocular low contrast visual performance on LogMAR scale [ Time Frame: 1 week ]
    • Monocular over refraction visual performance on LogMAR scale [ Time Frame: 1 Week ]
    • Monocular spherical aberration [ Time Frame: 1 week ]
      Assessed by aberrometry
    • Subjective assessment of visual comfort, eyestrain, fatigue [ Time Frame: 1 week ]
      Participants will respond to a sponsor provided questionnaire
    • Lens Fitting Efficiency and Timing [ Time Frame: 30 minutes ]
      Number of lens trials needed to determine an acceptable fit.


    Information By: Johnson & Johnson Vision Care, Inc.

    Dates:
    Date Received: May 8, 2013
    Date Started: September 2013
    Date Completion:
    Last Updated: May 5, 2017
    Last Verified: May 2017