Figures cited from ClinicalTrials.gov NCT03193736, the British Journal of Ophthalmology STAR-I paper, published bioaccess® Panama pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the clinic and trial those sources support. We do not claim iSTAR Medical or MINIject as a bioaccess® client.
If you searched Panama Eye Centre clinical trial, Orillac-Calvo MINIject, STAR-I Panama, or go direct to the eye clinic in Panama, you are following a clinic name that is genuinely in the public file. Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a real ophthalmic research site in Panama City. It is not the operator of the MINSA / CNBI file.
bioaccess®’s position is simple and it is not adversarial: Panama Eye Centre is the site. The First-in-Human CRO still owns MINSA/CNBI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Panama is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A STAR-I listing does not become a CRO.
This page is the intercept for the ophthalmic-clinic query. It does not clone clinical trials in Panama, the March 2026 Panama essay, or The Panama Clinic first-in-human. Those pages stay the country system and the large-hospital intercept (Axoft, Newrotex). This page answers the Orillac-Calvo / Panama Eye Centre search.
Why the clinic name wins the search — and why that is not a CRO
Device registries and journals write the implant, the city, and the site. They rarely write the CRO. MINIject STAR-I is the clean public example for this Panama City eye clinic.
NCT03193736 (STAR-I), retrieved 23 August 2026: official title is a prospective, open, multicenter clinical trial with one cohort analysing the efficacy and safety of MINIject in patients with open-angle glaucoma uncontrolled by topical hypotensive medications. Lead sponsor: iSTAR Medical. Status: completed. Start 19 June 2017; primary completion 16 April 2018; completion 25 November 2019. Locations listed: Maxivision Eye Hospital, Hyderabad, India, and Clinica de ojos Orillac-Calvo, Panama City, Panama.
The British Journal of Ophthalmology two-year STAR-I paper (trial registration NCT03193736) identifies the Panama site as Panama Eye Centre (previously Clínica de Ojos Orillac-Calvo), Panama City, Panama, and states IRB approval was obtained from that hospital (and from Maxivision). The paper reports a prospective, multicentre, first-in-human, single-arm study of stand-alone MINIject implantation in 25 patients; implants between June and October 2017 by three surgeons in Panama and India; two-year follow-up for 21 patients. We cite the published outcomes as journal facts, not as a bioaccess® result: mean IOP 23.2 to 13.8 mmHg at two years (-40.7 percent) on fewer medications, as the paper states. We will not add a PI name the registry listing we retrieved did not put in the site row.
That file is useful public information about a site-named Panama ophthalmic FIH. It is not a bioaccess® case study. As of this writing, bioaccess® does not list iSTAR Medical as a client on our published pages, and this article will not invent that relationship.
Panama Eye Centre is a site. The CRO is the operator.
A Panama City eye clinic can provide the OR, imaging, and surgeons who have already taken a supraciliary micro-invasive glaucoma device through a published first-in-human cohort. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.
What a site can typically do when a sponsor goes direct:
- Discuss investigator interest and surgical feasibility — when that service is available and appropriate for your device, which is not automatic.
- Share institutional ethics-committee calendars and clinic research rules.
- Quote procedure and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- MINSA and CNBI. Panama’s Ministry of Health, through the Dirección Nacional de Farmacia y Drogas, is the national health authority. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). A hallway conversation with a surgeon is not that file.
- Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a PI email.
- Clinical trial insurance. Required. Our Panama essay publishes a typical premium range of $5,000-$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
- The 21 CFR 812.28 package. Eligibility is not clearance, and a site MSA does not produce it.
- Multi-country optionality. If Panama enrollment or the indication later needs Colombia, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.
Going direct to Panama Eye Centre is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.
How MINSA and CNBI sit next to the clinic
Use the country pages for the full pathway. Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:
- On clinical-trials-panama: ethics typically 3-5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6-8 weeks. Per-patient costs on that page: $12,000-$22,000. A 10-patient FIH is described as typically $200K-$300K. Currency is the U.S. dollar.
- On the March 2026 blog: early-feasibility is ethics-committee-driven; CNBI often 4-8 weeks; conservative submission-to-first-patient envelope 3-5 months including site prep and screening.
Ask for a protocol-specific calendar. Do not treat a clinic hallway estimate as MINSA clearance. All bioaccess® Panama protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.
What the STAR-I public file actually supports — and what it does not
- Device: MINIject (iSTAR Medical), STAR-I, NCT03193736.
- Panama site: Clinica de ojos Orillac-Calvo on ClinicalTrials.gov; Panama Eye Centre, formerly Clinica de Ojos Orillac-Calvo, in the BJO paper.
- Design: prospective, multicentre, first-in-human, single-arm; 25 implanted; Panama and India; completed 2019 on the registry.
- Not claimed here: that iSTAR retained bioaccess®; that this clinic is The Panama Clinic; that Axoft or Newrotex ran here; that we have a named PI on this intercept beyond the three-surgeon statement in the journal (PD, CH, IKA) — we will not guess local identities those initials do not prove.
What the CRO still does after you have a clinic name
- Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
- Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
- A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.
bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates FIH device studies as a multi-country platform. That is the operator layer around a named Panama City eye clinic.
Do not smear the clinic
Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a serious ophthalmic resource. This page is not a critique of the site. A published STAR-I cohort is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator. If the hospital you actually typed was The Panama Clinic, use that intercept instead of stretching this one.
Colombia is still on the map
A Panama clinic search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Site versus CRO
| Workstream | Panama Eye Centre / the site | bioaccess® / the CRO |
|---|---|---|
| Procedure | OR, imaging, glaucoma service | Protocol fit, training, device accountability |
| Ethics | Institutional committee calendar | Packet, ICF, IB, CNBI-registered process |
| National authority | Not the permit holder by appearing on STAR-I | MINSA / CNBI |
| Import | Receiving and storage if contracted | Importer of record |
| Quality / FDA | Source documents from the cases | ISO 14155 + 21 CFR 812.28 narrative |
| Next country | One building in Panama City | Colombia (INVIMA) still on the platform |
Frequently asked questions
Can I contract Panama Eye Centre or Orillac-Calvo directly?
You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT03193736, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the clinic as the site if it is the right site for your protocol.
Is this the same as The Panama Clinic?
No. The Panama Clinic intercept covers Axoft and Newrotex via bioaccess® and Nanochon in independent press. This page is the sourced ophthalmic clinic for MINIject STAR-I. Do not merge the buildings.
What does the CRO still do if the clinic is already identified?
Regulatory-fit and country choice; the MINSA and CNBI packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia if Panama is not enough. The clinic still does the procedure.
Did bioaccess® run STAR-I?
We do not claim that. iSTAR Medical is the sponsor on the registry. This intercept exists because sponsors search the site name. It is not a STAR-I case study.
Next step
If the search that brought you here was Orillac-Calvo, Panama Eye Centre, or MINIject Panama, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Hospital: The Panama Clinic. Country: Panama, Colombia. Other clinics: CODET, Laser Center, Adrian Ebner.