Figures cited from the live ClinicalTrials.gov record NCT05317728 (last update posted 1 September 2026; first posted 8 April 2022) and the published bioaccess® Mexico country page, verified 3 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. No principal investigator is named on this NCT location row; we will not invent one. Alcon is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.
If you searched Salauno clinical trial, Salauno Salud SAPI de CV Mexico City, Alcon fluid accommodating IOL Mexico, BAL-FAIOL site, or “go direct to the Mexico City site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Salauno Salud SAPI de CV is a real named ophthalmology facility on that record. It is not the operator of the COFEPRIS file.
bioaccess®’s position is simple and it is not adversarial: Salauno Salud SAPI de CV is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, 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 Mexico City is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row does not become a CRO.
This page is the intercept for the Mexico City query. It does not clone clinical trials in Mexico. That page stays the country operating system. The two other Mexican rows on this same NCT get their own slugs: Asociación Para Evitar la Ceguera en México and Centro de Retina Médica y Quirúrgica Zapopan. This slug is the Salauno legal-entity string only. Salauno is a separate organisation from APEC and from Conde de Valenciana. Do not merge them.
Why the facility name wins the search — and why that is not a CRO
NCT05317728 is an industry device feasibility listing. Brief title: Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design. Official title: Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control. Organization study ID: ILR286-E002. Lead sponsor: Alcon Research, class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed. The only overall official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. There is no central contact and no principal investigator is named on any location row — we will not invent one.
Design on the 3 September 2026 snapshot: interventional; primary purpose DEVICE_FEASIBILITY; phase N/A; Cohort 1 randomized parallel-group with participant and outcomes-assessor masking, Cohort 2 single-group unmasked; actual enrollment 175; status ACTIVE_NOT_RECRUITING. Actual start 31 March 2023; estimated primary completion and completion November 2026. Study first posted 8 April 2022; last update posted 1 September 2026. Condition: cataract.
Interventions, in the registry’s words: the BAL-FAIOL IOL, an investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; a commercially available monofocal IOL control (other name AcrySof IQ monofocal IOL, SN60WF); and cataract surgery by phacoemulsification with a clear corneal incision. The oversight module records the study as an FDA-regulated device study of an unapproved device that is a U.S. export. That combination — unapproved investigational IOL, exported from the United States, run in Latin America under a feasibility purpose — is exactly the file a CRO carries.
The six location rows currently published:
- Clinica 20/20, San José, Costa Rica — already intercepted at clinica-20-20-san-jose-fih.
- Laser Center SA, Santo Domingo, Dominican Republic — already intercepted at laser-center-santo-domingo-fih.
- Centro de Retina Medica y Quirurgica SC, Zapopan, Jalisco, Mexico.
- Asociación Para Evitar la Ceguera en México, Mexico City.
- Salauno Salud SAPI de CV, Mexico City.
- Panama Eye Center, Panama City — already intercepted at panama-eye-centre-orillac-calvo-miniject.
Read the record as it is. Primary purpose is DEVICE_FEASIBILITY. The device is unapproved. Three of the six buildings are in Mexico, and until this batch none of the three had a dedicated public intercept. That is the site-direct leak: a sponsor searching a fluid-accommodating IOL, Alcon feasibility, or a Mexican ophthalmology campus lands on a named facility with no operator between them and the file.
Mexico City is a site. The CRO is the operator.
Salauno Salud SAPI de CV can provide cataract surgical volume, biometry and refractive outcome measurement, and surgeons who implant IOLs every week. That is necessary. It is not sufficient for an unapproved, U.S.-exported investigational lens a sponsor expects to defend later.
What a site can typically do when a sponsor “goes direct”:
- Discuss surgeon interest and surgical feasibility for an investigational IOL — when that service is available and appropriate for your lens, which is not automatic.
- Share institutional ethics-committee calendars and clinic research rules.
- Quote surgery, visit, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Monterrey dermatologist is not that dossier.
- Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
- Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a site-only premium here.
- ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
- Multi-country optionality. If one Mexican room is not enough, a single-clinic MSA will not stretch to Colombia, Panama, or Costa Rica.
Going direct to Salauno Salud SAPI de CV is how you confirm an operating list. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Salauno (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | OR list, phacoemulsification, biometry, refractive follow-up, local staff | Protocol fit, surgeon training, investigational IOL accountability |
| Ethics | Institutional committee calendar and local rules | Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012) |
| National authority | Not the permit holder by being listed on an NCT | COFEPRIS clinical-investigation file, in Spanish |
| Import | Receiving and storage if contracted | Importer of record for an unapproved, U.S.-exported lens |
| Quality | Clinic quality and the case | ISO 14155 monitoring, EDC, AE reporting, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One building on a six-site record | Colombia (INVIMA) and the rest of the bioaccess® platform |
How COFEPRIS and ethics sit next to the clinic
Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:
- Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
- Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
- The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
- All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
- Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
- bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.
We will not invent a facility-only day count. Ask for a protocol-specific calendar. A clinic email is not a COFEPRIS authorization.
What the Alcon public file actually supports — and what it does not
- Device: BAL-FAIOL fluid-accommodating intraocular lens, investigational and implantable, versus an AcrySof IQ SN60WF monofocal control, as described on NCT05317728.
- Sponsor: Alcon Research (industry). No collaborator. No CRO named.
- Site: Salauno Salud SAPI de CV — one of six published location rows.
- Design: DEVICE_FEASIBILITY, phase N/A, actual n=175, ACTIVE_NOT_RECRUITING, actual start 31 March 2023, estimated completion November 2026.
- Regulatory flags on the record: FDA-regulated device; unapproved device; U.S. export.
- Not claimed here: that the NCT named bioaccess®; that Alcon is a bioaccess® client; that we have BAL-FAIOL outcomes; that a named investigator exists on this row when the registry prints none; that this facility is the same building as any sibling intercept.
What the CRO still does after you have a clinic name
- Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
- Importer of record and device accountability across every activated row.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
- Optionality across Costa Rica, the Dominican Republic, Panama, Colombia, and the rest of the platform when one campus is not enough.
The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO and LATAM FIH hospitals vs the CRO.
Frequently asked questions
Can I contract Salauno Salud SAPI de CV directly?
You can try. The facility can discuss surgeon interest, local case costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Alcon listed it on a registry row. Contract the CRO; let the CRO activate the site.
Did bioaccess® run the Alcon fluid-accommodating IOL study?
No public bioaccess® page says so. We will not invent that claim. This page intercepts the search; it does not claim the study.
Who is the principal investigator at this site?
The registry does not name one on this location row, and neither will we. The only official on the record is an unnamed “Clinical Trial Lead, Surgical” at Alcon Research, LLC. A page that invents a surgeon name to look authoritative is a page a sponsor should not trust.
The study is ACTIVE_NOT_RECRUITING. Why does this page exist?
Because the row is still published and still ranks. Sponsors planning the next feasibility IOL study search the campus strings on the last one. Enrollment status changes; the search behaviour does not.
Is Colombia still an option?
Yes. bioaccess® still runs trials in Colombia. A Mexican ophthalmology search is not an instruction to abandon INVIMA. See CRO in Colombia.
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