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Concept Clearance – NEI Collaborative Clinical Vision Research

Author: Collaborative Clinical Research Program: Don Everett, MA (Presenter); Jimmy Le, ScD, MA; Merideth Brown Shifflett, MS; Azadeh Shoaibi, PhD; Negin Atri, DrPH and Maryann Redford, DDS, MPH

Council Date: December 9, 2025

Goal: 

The purpose of this concept clearance is re-issuance of a program announcement to promote Collaborative Clinical Vision Research that advances NEI’s mission to eliminate vision loss and improve quality of life through vision research. The goal is to support complex, multi-center clinical trials that involve high safety or resource risk and complex, multi-center epidemiologic studies.

Rationale: 

This NEI initiative addresses chronic diseases across the lifespan through research on the burden of eye and vision conditions, their causes, diagnoses, prevention, treatment, and rehabilitation. The NEI uses UG1 cooperative agreement awards to support investigator-initiated Collaborative Clinical Vision Research. These UG1 studies are multifaceted and of high public health significance requiring specialized coordination of multiple interacting components that maximize study resources and expertise. The scale and complexity of these projects necessitate clear delineation of overall project structure and study responsibilities and require careful safety and performance oversight and resource monitoring by National Institutes of Health (NIH) staff. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study rationale, design, analytic techniques, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements. 

Objectives and Scope: 

This NEI initiative has far-reaching and lasting impacts. NEI Collaborative Clinical Vision Research projects address eye care needs, inform clinical practice, optimize health care delivery, and improve the well-being of Americans. Examples include, but are not limited to, the following: 

  • Determining the burden (prevalence and incidence) of eye diseases and conditions, and their visual outcomes in a changing population.
  • Improving diagnosis of ocular diseases and their underlying processes through new screening and detection strategies.
  • Developing and testing interventions that prevent or treat eye diseases and resulting visual impairment and identify predictors of response to treatment.
  • Identifying and assessing strategies that will overcome barriers to eye care and convert evidence-based findings into improved patient and population outcomes.
  • Investigating gene-transfer, stem-cell therapy, and other novel interventions to manage eye conditions and ocular manifestations of chronic diseases. 

The use of innovative and efficient study designs is encouraged, such as adaptive dose-finding designs, designs incorporating plans for sample size recalculation, and futility designs. Investigators are also encouraged to consider utilizing digital, mobile, and sensor technologies or web-based systems to facilitate data collection and harmonization.

Last updated: December 19, 2025

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