Ocular Clinical Trial Variability: An AACT Landscape Analysis (1999-2025) and Cross-Sectional Study
Abstract/Description/Artist Statement
Background
Ophthalmic research is pivoting toward durable pharmacotherapy, gene therapy, and digital modalities, yet standard surveillance often fails to capture the field's scale. This study systematically mapped the landscape to identify therapeutic concentrations, regulatory shifts, and funding gaps.
Methods
A retrospective, cross-sectional landscape analysis of ClinicalTrials.gov records (1999-2025) was performed. To address delayed MeSH indexing, we employed a hybrid inclusion strategy combining the "Eye Diseases" Medical Subject Heading (MeSH) ancestor term(s) with ophthalmology-specific text searches regex text-mining across five descriptive fields. Trials were classified by subspecialty and intervention modality using a deterministic priority hierarchy. AI and digital technology integration was identified via non-exclusive tags, and lead sponsors were categorized by agency type.
Results
Of 18,675 trials identified, 5,409 (29%) escaped standard MeSH indexing. While Retina (n=4,971) and Cornea (n=3,885) dominated, pediatric and strabismus trials had low industry sponsorship (5.7% vs. 55.8% in refractive surgery). The "other" retina category (non-pharmacologic and non-surgical) expanded to 44.6% of retinal research by 2025, signaling a post-pandemic shift toward contact-less methodologies. Separately, 93.4% of growing AI/digital technology trials lack standard pharmaceutical phases, reflecting the Software as a Medical Device regulatory pathway.
Conclusion
Current surveillance underrepresents the ophthalmic research ecosystem by nearly 30%. The field is characterized by a significant misalignment between commercial incentive and clinical necessity, with pediatric and rare disease research facing "commercial neglect." Findings call for modernized registry taxonomies and targeted non-industry funding to ensure innovation scales with the global burden of vision loss.
Faculty Advisor/Mentor
Dr. Giovanni DiSandro, MD
Faculty Advisor/Mentor Email
disandg@odu.edu
Faculty Advisor/Mentor Department
Ophthalmology
College/School Affiliation
Eastern Virginia School of Medicine
Student Level Group
Medical
Presentation Type
Poster
Ocular Clinical Trial Variability: An AACT Landscape Analysis (1999-2025) and Cross-Sectional Study
Background
Ophthalmic research is pivoting toward durable pharmacotherapy, gene therapy, and digital modalities, yet standard surveillance often fails to capture the field's scale. This study systematically mapped the landscape to identify therapeutic concentrations, regulatory shifts, and funding gaps.
Methods
A retrospective, cross-sectional landscape analysis of ClinicalTrials.gov records (1999-2025) was performed. To address delayed MeSH indexing, we employed a hybrid inclusion strategy combining the "Eye Diseases" Medical Subject Heading (MeSH) ancestor term(s) with ophthalmology-specific text searches regex text-mining across five descriptive fields. Trials were classified by subspecialty and intervention modality using a deterministic priority hierarchy. AI and digital technology integration was identified via non-exclusive tags, and lead sponsors were categorized by agency type.
Results
Of 18,675 trials identified, 5,409 (29%) escaped standard MeSH indexing. While Retina (n=4,971) and Cornea (n=3,885) dominated, pediatric and strabismus trials had low industry sponsorship (5.7% vs. 55.8% in refractive surgery). The "other" retina category (non-pharmacologic and non-surgical) expanded to 44.6% of retinal research by 2025, signaling a post-pandemic shift toward contact-less methodologies. Separately, 93.4% of growing AI/digital technology trials lack standard pharmaceutical phases, reflecting the Software as a Medical Device regulatory pathway.
Conclusion
Current surveillance underrepresents the ophthalmic research ecosystem by nearly 30%. The field is characterized by a significant misalignment between commercial incentive and clinical necessity, with pediatric and rare disease research facing "commercial neglect." Findings call for modernized registry taxonomies and targeted non-industry funding to ensure innovation scales with the global burden of vision loss.