The Quality of Reporting on Glaucoma Surgical Innovations during Early Development Stages Using Idea, Development,...

Area of Science:

• Ophthalmology
• Surgical Innovation
• Medical Device Development

Background:

• Glaucoma surgical practices have evolved significantly over the past two decades.
• Novel surgical techniques and devices are crucial for advancing patient care in glaucoma management.
• Evaluating and reporting on surgical innovations presents unique challenges.

Purpose of the Study:

• To investigate the conduct and reporting of early-stage glaucoma surgical innovations.
• To assess the quality of reporting for new glaucoma surgical techniques and devices using the IDEAL framework.

Main Methods:

• A comprehensive search was conducted for glaucoma surgical innovations introduced in the last 20 years.
• Initial reports, including "first-in-human" studies and first case series, were identified across multiple databases and grey literature.
• The IDEAL collaboration stages 1 (idea) and 2a (development) checklists were used to evaluate reporting quality, focusing on study design, consent, protocols, and ethical/regulatory approvals.

Main Results:

• Twenty-one distinct techniques and devices were identified across 53 studies.
• In IDEAL stage 1 (earliest reports), 81.8% identified the innovation, and 77.3% provided structured summaries, but only 9% detailed informed consent, and 59% lacked ethical approval references.
• In IDEAL stage 2a (development assessment), 77% included structured summaries, and 70% discussed future evaluation needs, yet only 13% detailed informed consent, and 80% omitted regulatory approval details. A pre-study protocol was available in only one study.

Conclusions:

• Early-phase glaucoma surgical studies frequently omit critical elements of study design and reporting.
• The IDEAL framework provides a structured approach to address these reporting deficiencies.
• Implementing the IDEAL framework can enhance the quality of reporting for glaucoma surgical innovations, ultimately improving patient care.