OPIA is the eSource platform for ophthalmic clinical trials. Real-time treatment-criteria alerts. Longitudinal endpoint tracking. Visit-type-specific assessment workflows. Designed by someone who has been at the bench, not just at the demo screen.
Most ophthalmic sites still capture source data on paper or on EDC platforms designed for general therapeutic areas. The result is missed criteria, query backlogs, and protocol deviations that a purpose-built tool would have prevented.
Treatment criteria require comparing today's BCVA and CST against the subject's best and lowest values across the entire study. Today, that calculation lives in coordinator memory or a paper chart. Subjects who qualify for supplemental treatment get missed. It is a protocol deviation. It is a patient who didn't get the treatment they qualified for.
Sites operate Heidelberg Spectralis, Optos California, Zeiss Cirrus, and others. Each has its own export format. Coordinators manage the routing to sponsor EDCs and reading centers manually, per camera, per study. Mislinks and missed uploads are common.
Platforms designed for broad therapeutic areas lack ocular-specific fields, leading to free-text workarounds, query backlogs, and inconsistent data. Smaller sites can't build their own. The result is a persistent gap that OPIA closes.
OPIA's core capability is a longitudinal endpoint tracking engine that monitors each subject's BCVA and OCT-derived CST across every visit and applies protocol-specific treatment criteria in real time. When a subject meets criteria, OPIA surfaces a prominent in-platform alert at the point of care — before the visit ends.
OPIA is configured per-study at setup: visit cadence, assessments per visit type, treatment criteria thresholds, and alert logic. AND-gated, OR-gated, fluid-attribution-required — whatever your protocol specifies. Not a generic tool you adapt; a tool configured to your study.
Coordinator-friendly capture forms for BCVA (with ETDRS chart), IOP, SD-OCT, ocular exam, and protocol-specific assessments. Automatic best-BCVA and lowest-CST tracking. Visit-window indicators and assessment checklists that update per visit type.
When protocol criteria fire, OPIA shows a front-and-center alert with the gating logic explained: which thresholds were exceeded, which weren't, and what action the protocol calls for. Not buried in a report. Not flagged on the next monitor visit. At the point of care.
OPIA launches in retina because retina has the most acute longitudinal-tracking pain — the supplemental-injection criteria, the OCT-driven workflows, the multi-camera imaging fragmentation. Every subspecialty extension is customer-pulled, not founder-pushed. The platform's configuration model supports any ophthalmology trial design.
| Subspecialty | Status | Endpoints that drive criteria | Hot trial areas |
|---|---|---|---|
|
Retina
Vitreoretinal medical & surgical
|
Live | BCVA · CST · IRF/SRF GA area |
Anti-VEGF (faricimab, aflibercept HD, sustained-release inserts), geographic atrophy, gene therapy |
|
Glaucoma
Adult open-angle and angle-closure
|
Next | IOP · VF MD/PSD OCT-RNFL thinning rate |
Sustained-release implants, MIGS devices, neuroprotection trials |
|
Cornea
Surface, ectasia, ocular surface disease
|
Roadmap | BCVA · NEI staining K-max · Schirmer · pachymetry |
Corneal cross-linking, neurotrophic keratitis (cenegermin), presbyopia drops, dry eye |
|
Pediatric ophthalmology
Refractive, strabismus, ROP
|
Roadmap | Refractive error · Axial length BCVA · Stereoacuity |
Myopia control (atropine, MiSight, repeated low-level red light), amblyopia, ROP |
|
Oculoplastics
Orbit, lid, lacrimal
|
Roadmap | Proptosis (Hertel) Clinical Activity Score · diplopia |
Thyroid eye disease (post-Tepezza follow-ons), aesthetic indications |
|
Neuro-ophthalmology
Optic nerve, afferent visual pathway
|
Roadmap | BCVA · VF · OCT-RNFL/GCL Color vision · MRI lesion burden |
NMO, LHON gene therapy, optic neuritis recovery agents, IIH |
"Roadmap" status means the platform's configuration model already supports the subspecialty; we build the subspecialty-specific UI, imaging integrations, and reference protocols when a pilot site requests it. Talk to us if you run trials in any of these areas.
Every data point captured in OPIA is timestamped, audit-trailed, and user-attributed at the point of entry. The platform aligns with FDA 21 CFR Part 11, ALCOA+ data integrity, and HIPAA infrastructure standards.
Time-stamped, attributable, and audit-trailed at the point of capture. Electronic signatures with intent attestation. Tamper-evident audit log with full record of who changed what, when, and why.
HIPAA-aligned cloud infrastructure with executed Business Associate Agreement. Encryption at rest and in transit. Role-based access controls and minimum-necessary disclosure principles enforced at the platform level.
Attributable, Legible, Contemporaneous, Original, Accurate — plus complete, consistent, enduring, and available. The data integrity standard FDA expects from electronic source records, designed in from the platform's first commit.
Victor brings direct clinical research and CRO experience to OPIA, with a clinical research background spanning ophthalmology trial operations. OPIA exists because the workflow problems his coordinators described to him — missed supplemental injections, paper source charts, manual image uploads — are the same problems coordinators across the country still face today.
The product is built around what coordinators actually do at the bench, not what an outside software team imagines they do. Every workflow in OPIA traces to a specific pain point identified in customer discovery interviews with retina trial coordinators.
OPIA pilots are configured to your active protocol at no cost during the pilot period. Twelve weeks. One subject. Two hours of coordinator time per week. Either party can end the pilot at any time, in writing.
A few questions so we can tell if it's a fit before scheduling a call.
Thanks — we'll follow up within 1–2 business days to see if it's a fit and find time for a short call.