The quality of reporting on Glaucoma Surgical Innovations during Early Development Stages using IDEAL Guidelines: a Systematic Review.

TOPIC

Glaucoma surgical practice has changed over the past 2 decades. We investigated how the earliest stages of glaucoma surgical innovations have been conducted and reported.

CLINICAL RELEVANCE

Surgical innovations are crucial to improve patient care. However, developing novel techniques and devices presents unique challenges that make rigorous evaluation and reporting difficult. To support surgeons and researchers, the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) collaboration has issued guidelines aimed at facilitating improvements in the conduct and reporting of surgical innovations at different stages.

METHODS

We have considered all glaucoma surgical innovations introduced in the past 2 decades and searched for the initial reports of each technique, targeting "first-in-human" and first case series. We have searched for human studies in PubMed Central, Scopus, Google Scholar, Clinicaltrials.gov., and grey literature was also included. We used the IDEAL collaboration stages 1 ("idea") and 2a ("development") checklists to assess the quality of reporting. Checklists include items on study design, consenting, protocol availability, ethical and regulatory approvals. The study protocol was prospectively registered at Open Science Framework.

RESULTS

We identified 21 different techniques and devices. Among the 53 included studies, 22 were earliest reports (IDEAL stage 1) and 31 were categorized as development assessment (IDEAL stage 2a). The techniques most represented were trabecular dilatation or disrupting surgeries (25 studies), trabecular stenting (10 studies) and suprachoroidal devices (10 studies). In the IDEAL stage 1, 81.8% of studies identified the device or technique in the title or abstract or referred to the "first-in-human" experience, and 77.3% provided structured summaries, with detailed outcome measures. Technical feasibility was addressed in 63.6% of studies, however only 9% explicitly described an informed consent process, and 59% lacked references to ethical approvals. In the IDEAL stage 2a, 77% of studies included structured summaries, and 70% discussed the need for evaluation in a prospective multicenter study. Clinical outcomes, adverse events and modifications to techniques were reported in equal proportion (61.3%); furthermore, 70% discussed the feasibility of further evaluation. Nevertheless, only 13% detailed the informed consent process, and 80% omitted details of regulatory approvals. A pre-study protocol was available in only 1 study.

CONCLUSION

Critical aspects of study design and reporting were frequently missing in early-phase surgical studies of glaucoma. The IDEAL framework offers a structured approach to bridge these gaps and improve the quality of glaucoma surgical innovation reporting.