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Sample size calculations for ophthalmologic studies.

W J Gauderman1, W E Barlow

  • 1Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles 90033.

Archives of Ophthalmology (Chicago, Ill. : 1960)
|May 1, 1992
PubMed
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This study provides sample size calculations for ophthalmologic trials comparing two treatments. It covers single-eye, paired-eye, and mixed designs, accounting for eye correlation to ensure accurate statistical power for research.

Area of Science:

  • Ophthalmology
  • Biostatistics
  • Clinical Trials

Background:

  • Determining appropriate sample size is crucial for the statistical validity of clinical trials.
  • Ophthalmologic studies often involve complex designs due to the use of one or both eyes.

Purpose of the Study:

  • To present sample size calculation methods for common ophthalmologic study designs.
  • To address designs involving single-eye, paired-eye, and mixed-eye subject eligibility.
  • To provide tools for accurate statistical power determination in ophthalmic research.

Main Methods:

  • Formulas for sample size calculations were developed for three distinct study designs.
  • Consideration was given to both continuous and binary outcome measures.
  • A correction factor was incorporated to account for the correlation between eyes in paired designs.

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  • Formulas for design 3 accommodate a mix of single-eye and double-eye eligible subjects.

    • Main Results:

    • The study provides specific methodologies for sample size determination across various ophthalmologic study configurations.
    • The methods account for inter-eye correlation, enhancing the precision of sample size estimates.
    • The presented formulas are applicable to both continuous and binary data.

    Conclusions:

    • The developed methods offer a robust framework for sample size calculations in ophthalmologic research.
    • Accurate sample size determination is facilitated for common study designs, improving trial efficiency.
    • A computer program is available to assist researchers in performing these essential calculations.