Optometry & Contact Lenses (OCL) Article series on biostatistics in ophthalmology and optometry
The current issue (Vol. 6, No. 2) of Optometry & Contact Lenses (OCL) features the third instalment in a series on biostatistics in ophthalmology and optometry. The article “Design and Analysis of Clinical Research in Ophthalmology and Optometry” by Dr. Daniela Oehring, Professor in Eye and Vision Science an der University of Plymouth, addresses modern clinical study designs and their statistical analysis.
The focus is on the fundamental principles of study planning and the use of appropriate statistical methods to ensure valid and reproducible research results in ophthalmology and optometry. Building on the fundamentals of statistical methods and inferential statistical procedures covered in the first two parts, the third article is dedicated to the practical planning of clinical studies. In this article, Dr. Daniela Oehring describes how clinical research, study design, and statistical analysis are interrelated and which methodological requirements must be met to achieve valid and clinically relevant results.
A central theme of the article is the careful formulation of the research question, as this forms the basis for selecting an appropriate study design. Various scientific frameworks for developing clinical research questions are presented, including the PICO, PEO, and CoCoPop models, as well as the FINER criteria for assessing scientific relevance and feasibility. The author demonstrates how these concepts can help develop clinically meaningful and methodologically sound studies.
In addition, the article provides an overview of classic and modern study designs in ophthalmological and optometric research. Alongside randomised controlled trials, innovative approaches such as adaptive or decentralized study designs are also presented. These methods enable more flexible study procedures, the parallel investigation of multiple treatment options, and individually tailored treatment strategies. At the same time, they help make clinical research more efficient, practice- oriented, and patient-centred. The respective strengths and limitations of the various study designs are explained, and guidelines are provided for their appropriate selection.
Another focus is on the specific requirements of ophthalmological research. Since both of a patient’s eyes are typically examined, statistical methods must account for what is known as inter-eye correlation. In addition, the article discusses challenges related to the blinding of surgical proceduresas well as modern methods for controlling for bias and confounding factors. These include propensity score methods and target trial emulation, which enable a more realistic and scientifically robust analysis of observational data.
The article also devotes special attention to the new estimand framework in accordance with ICHE9(R1). This international concept precisely defines which treatment effects clinical trials should capture and how to handle treatment discontinuations, rescue medication, or treatment changes. The goal is to make study results easier to interpret and more relevant to clinical practice. In conclusion, the article emphasises that methodological weaknesses remain among the key challenges facing clinical research. Inadequate planning of sample size, inappropriate statistical methods or flaws in study design can significantly limit the validity of scientific findings. Furthermore, new studies are often conducted without sufficient consideration of existing evidence. The article therefore underscores the importance of systematic reviews and careful study planning as essential prerequisites for robust and clinically relevant research findings.
Together, the first three articles in the series form the basis for the subsequent discussions on statistical analyses and their application in ophthalmology and optometry. The next article will focus on data visualisation techniques for the effective presentation of research findings, followed by Part 5, which will examine advanced statistical methods and their practical application.
Every article in the OCL undergoes a peer-review process prior to publication: submitted manuscripts are reviewed by independent experts in the same field before publication. The VDCO’s journal thus ensures the quality of the published articles, which are evidence-based, methodologically rigorous, trustworthy, promote innovation, and are professionally relevant.