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Related Experiment Videos

The Berkeley Contact Lens Extended Wear Study. Part I : Study design and conduct.

R E Fusaro1, K A Polse, A D Graham

  • 1Division of Public Health Biology and Epidemiology, School of Public Health, University of California, Berkeley, California 94720-2020, USA.

Ophthalmology
|July 27, 2001
PubMed
Summary

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This study investigated if higher oxygen permeability rigid gas-permeable (RGP) contact lenses reduce eye damage during extended wear (EW). The trial design and subject data were established for future analysis of RGP EW safety and efficacy.

Area of Science:

  • Ophthalmology
  • Corneal Physiology
  • Contact Lens Technology

Background:

  • Extended wear (EW) of rigid gas-permeable (RGP) contact lenses is associated with risks like contact lens-associated keratopathy (CLAK).
  • Higher oxygen permeability (Dk) lenses are hypothesized to mitigate these risks.
  • Understanding the impact of Dk on CLAK incidence and lens survival is crucial for patient safety.

Purpose of the Study:

  • To test if higher Dk RGP lenses reduce CLAK incidence during EW.
  • To determine if higher Dk RGP lenses improve survival rates in EW.
  • To detail the clinical trial design, recruitment, retention, and baseline characteristics of the Berkeley Contact Lens Extended Wear Study (CLEWS).

Main Methods:

  • A randomized, concurrently controlled clinical trial.

Related Experiment Videos

  • Subjects adapted to day wear (DW) high-Dk RGP lenses before transitioning to EW.
  • Adapted EW subjects were randomized to 12 months of 6-nights/week EW with either high- or medium-Dk RGP lenses.

    • Main Results:

    • 201 of 545 subjects successfully adapted to EW and were randomized.
    • Baseline characteristics were similar between the medium- and high-Dk groups.
    • Distinct oxygen transmissibility levels were confirmed between the study groups, ensuring different hypoxia exposures.

    Conclusions:

    • The CLEWS trial was appropriately designed to test hypotheses regarding RGP EW.
    • The study adhered to rigorous protocols ensuring subject safety and data integrity.
    • The established internal validity and characterized population allow for informed interpretation of results for general contact lens wearers.