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Design and Conduct of Randomized Clinical Trials Evaluating Surgical Innovations in Ophthalmology: A Systematic

Augusto Azuara-Blanco1, Aaron Carlisle2, Matthew O'Donnell1

  • 1From the Centre for Public Health (A.A.-B., A.C., M.O.D.), Belfast, UK.

American Journal of Ophthalmology
|December 24, 2022
PubMed
Abstract

Insights

Key aspects of novel ophthalmic surgical trials, including surgeon experience and trial registration, are frequently missing. The IDEAL framework can enhance the quality of future surgical study designs.

Area of Science:

  • Ophthalmology
  • Surgical Innovation
  • Clinical Trials

Background:

  • Randomized controlled trials (RCTs) are crucial for evaluating novel surgical techniques.
  • Surgical RCTs present unique methodological challenges that can impact patient care.
  • This study investigates the design, conduct, and reporting of RCTs for novel ophthalmic surgeries.

Approach:

  • A systematic review was conducted to analyze RCTs of novel surgeries for cataract, vitreoretinal, glaucoma, and corneal diseases.
  • Studies published between January 1, 2016, and June 16, 2021, were identified through comprehensive database searches.
  • The review focused on key methodological aspects, including surgeon expertise, learning curve, quality assurance, and trial registration.

Key Points:

  • Only 57% of the 52 reviewed ophthalmic surgery RCTs reported surgeon experience, with only 21% specifying it for both intervention and control groups.
  • Details on the number of prior cases for a surgical innovation were reported in only 19% of studies.
  • Trial registration was inconsistently reported, with 53% of studies lacking any registration record.

Conclusions:

  • Significant gaps exist in reporting crucial design elements for novel ophthalmic surgical RCTs, such as surgeon experience and quality assurance.
  • The findings highlight the need for standardized reporting guidelines to improve the rigor of surgical trials.
  • Adoption of frameworks like the IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) framework is recommended to enhance the quality and reliability of surgical innovation research.

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