Built for ophthalmology · Proven in retina · Configured for every subspecialty

Ophthalmology eSource, purpose-built per protocol.

OPIA is the eSource platform for ophthalmic clinical trials. Real-time treatment-criteria alerts. Longitudinal tracking of your protocol's endpoints, whatever the subspecialty. Visit-type-specific assessment workflows. Designed by someone who has been at the bench, not just at the demo screen.

Request a pilot → See the product
Designed around 21 CFR Part 11 Role-based access, scoped per study Built on ALCOA+ principles
The problem

Ophthalmic trials are uniquely complex. Their tools are not.

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.

1

Missed treatment criteria

Treatment criteria require comparing today's measurements against the subject's history across the entire study: best BCVA and lowest CST in a retina trial, IOP against target in a glaucoma trial. Today, that calculation lives in coordinator memory or a paper chart. Subjects who qualify for treatment get missed. It is a protocol deviation. It is a patient who didn't get the treatment they qualified for.

2

Device reports live outside the source record

OCT, visual field and optic nerve reports come off a different device for each test, each with its own printout. Coordinators re-type the numbers by hand, file the printouts in a binder, and monitors check one against the other page by page. Transcription errors and missing printouts are common, and they surface weeks later as queries.

3

Generic eSource does not fit

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.

The product

Track your protocol's endpoints, whatever the subspecialty.

OPIA's core capability is a longitudinal endpoint engine. It follows each subject's protocol-defined measures across every visit and applies your treatment criteria in real time. The measures differ by trial: BCVA and CST in retina; IOP, visual field and RNFL in glaucoma; corneal staining, Schirmer, pachymetry and Kmax in cornea. The workflow doesn't. When a subject meets criteria, OPIA surfaces a prominent in-platform alert at the point of care — before the visit ends.

1

Configure to your protocol

Each study is set up to its protocol by the OPIA team: visit cadence, assessments per visit type, the endpoints that matter for your trial, and the treatment criteria your protocol specifies. Not a generic tool you adapt; a tool configured to your study.

2

Capture visits in real time

Coordinator-friendly capture forms for the assessments your protocol specifies: visual acuity (with ETDRS chart), IOP, OCT, visual field, optic nerve imaging, ocular exam, and protocol-specific forms. Each endpoint is tracked over time — best BCVA and lowest CST in retina, IOP against target and RNFL change in glaucoma. Visit-window indicators and assessment checklists update per visit type.

3

See alerts before the subject leaves

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.

One engine, every subspecialty
Retina Live
BCVA · CST · IRF/SRF
Supplemental-treatment criteria
Glaucoma Preview
IOP vs target · VF MD/PSD/VFI
RNFL and cup-to-disc tracking
Cornea Preview
BCVA · IOP · NEI corneal staining
Schirmer · pachymetry · Kmax

Retina is in pilot today. Glaucoma and cornea configurations are built and available to validate with a pilot site; other subspecialties are configured when a site requests them.

Subspecialty roadmap

Starting with retina by design.

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 is built to extend beyond retina.

Subspecialty Status Endpoints that drive criteria Hot trial areas
Retina
Vitreoretinal medical & surgical
 Live BCVA · CST · IRF/SRF
Geographic atrophy		 Anti-VEGF (faricimab, aflibercept HD, sustained-release inserts), geographic atrophy, gene therapy
Glaucoma
Adult open-angle and angle-closure
 Preview IOP · VF MD/PSD
RNFL change from baseline		 Sustained-release implants, MIGS devices, neuroprotection trials
Cornea
Surface, ectasia, ocular surface disease
 Preview 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

"Preview" means a working configuration has been built and tested with synthetic data, and is ready to validate with a pilot site. "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.

Platform capability

Beyond eSource: the site's regulatory binder, done right.

Not a subspecialty extension — built into every OPIA site alongside eSource, not a bolt-on integration.

Capability Status What it adds
Site regulatory documents (eISF)
Essential-document management
 Live A structured regulatory binder built into OPIA — pre-built essential-document categories instead of a blank folder, expiration alerts on CVs/licenses/IRB approvals, full version history on every document (who changed what, when, with the prior file still retrievable), and the same remote CRA review your monitoring visits already rely on. An automated quality-check layer flags likely ALCOA+ issues — missing, unsigned, expired, or illegible filings — before a monitor or auditor finds them.
Compliance

Built for the regulatory bar that ophthalmic trials require.

Every data point captured in OPIA is timestamped, audit-trailed, and user-attributed at the point of entry. OPIA is designed around FDA 21 CFR Part 11 and built on ALCOA+ data-integrity principles. It has not yet had a formal compliance review, so pilots run on synthetic or de-identified data.

21 CFR Part 11

Electronic records and signatures

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.

Privacy

Protected health information

Role-based, study-scoped access: each person sees only the studies they are assigned. Data is encrypted in transit and at rest by the cloud database provider. A Business Associate Agreement and a formal HIPAA review come before any real patient data; until then pilots use synthetic or de-identified data.

ALCOA+

Data integrity

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.

About

Built by a clinical research professional, for the people who run ophthalmology trials.

Victor Munoz, Founder and CEO of OPIA

Victor Munoz

Founder & CEO · OPIA Clinical LLC
Certified Clinical Research Associate (CCRA) · 13 years combined in ophthalmology and clinical research

Victor founded OPIA after 13 combined years in ophthalmology and clinical research. The workflow problems coordinators described to him — treatment criteria that get missed, paper source charts, images routed by hand — are the same problems sites across the country still face today.

OPIA is built around what coordinators and monitors actually do. It began in retina and now covers the whole site workflow in one place: visit data capture, treatment-criteria alerts, source verification for CRAs, the regulatory binder, and an audit trail built on ALCOA+ data-integrity principles. Each study is configured to its protocol, and glaucoma and cornea configurations are already in preview.

support@opiaclinical.com

Run a pilot at your site.

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.

Currently piloting in retina · Glaucoma and cornea configurations in preview · Other subspecialties are built when a site asks.
Prefer email? support@opiaclinical.com

Request a pilot

A few questions so we can tell if it's a fit before scheduling a call.

✓

Request received.

Thanks — we'll follow up within 1–2 business days to see if it's a fit and find time for a short call.