Figures cited from the live ClinicalTrials.gov record NCT07147192 and published bioaccess® country pages, verified 23 August 2026; registry status re-checked 27 September 2026. General information, not legal or regulatory advice. Confirm current SRS, CNEIS, MINSA, DIGEMAPS, and FDA rules with qualified advisers. We name only facilities that appear on that record. bioaccess® is not listed on the NCT and no bioaccess® page claims this Alcon study. “Alcon Investigator 8071” is not used as a clinic name.
If you searched Centro Panamericano de Ojos clinical trial, Clínica López Beltrán San Salvador, Alcon accommodating IOL El Salvador, or “go direct to López Beltrán,” you followed a facility string ClinicalTrials.gov actually published: Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador, El Salvador. That clinic is a real ophthalmic site. It is not the operator of the SRS file.
bioaccess®’s position is simple and it is not adversarial: López Beltrán / Centro Panamericano is the site. The First-in-Human CRO still owns SRS / CNEIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to run or add Colombia, Panama, Costa Rica, or the Dominican Republic if one San Salvador room is not the design. Sponsors who skip the CRO and email the clinic still have to rebuild that stack.
This page does not clone clinical trials in El Salvador. That page stays the country system. This page answers the site-named query.
What NCT07147192 actually says (re-checked 27 September 2026)
NCT07147192 — brief and official title: Feasibility Study of an Accommodating IOL Design. Lead sponsor: Alcon Research (industry). Organization study ID: ILK345-E001. Overall status on the live record: ACTIVE_NOT_RECRUITING (last update posted 2 September 2026). Actual start 3 December 2025; estimated primary completion October 2026 and estimated study completion October 2026; estimated enrollment 85; study type interventional; non-randomized parallel / contralateral implantation; primary purpose DEVICE_FEASIBILITY; no masking. Interventions listed: AAL-FAIOL, BAL-FAIOL, and phacoemulsification. Condition: aphakia; keyword: cataract. Brief summary: assess safety and explore usability and effectiveness of the test product AAL-FAIOL; “This study will be conducted in Central America.”
Design on the record: adult subjects who require cataract surgery in both eyes; one eye receives AAL-FAIOL and the other BAL-FAIOL, surgeries 14–35 days apart; follow-up about one year; the AAL lens may be laser-adjusted after surgery if needed. Primary outcome: cumulative ocular adverse events, including secondary surgical interventions. Ages 22 years and older; not healthy volunteers. Central contact is Alcon Call Center, not a San Salvador investigator name. Study director: Clinical Trial Lead, Surgical, Alcon Research, LLC.
Location rows, copied as listed. The record no longer shows a per-site recruitment status for any of them:
- Clinica 20/20 — San José, Costa Rica
- Instituto Espaillat Cabral — Santo Domingo, Dominican Republic
- Centro Panamericano de Ojos / Clinica Lopez Beltran — San Salvador, El Salvador
- Panama Eye Center — Panama City, Panama
The study is no longer enrolling on the public record, and its estimated completion is October 2026. The record names no local investigator for the San Salvador row, and this page does not name one either.
The same clinic, listed as Centro Panamericano de Ojos (San Salvador), is also one of three San Salvador facilities on NCT02486237, an observational historic cohort of complications in Central American diabetic patients. The sponsor is Clínica Los Yoses (Costa Rica). Status: COMPLETED April 2016, actual enrollment 225. That record is observational, not device work.
The clinic is a site. The CRO is the operator.
A San Salvador eye clinic can provide phacoemulsification rooms and surgeons who can, when activated, implant an investigational accommodating IOL. That is necessary. It is not sufficient for a device-feasibility file a U.S. board expects to survive FDA review — especially a four-country Central American design.
What the site typically owns: investigator interest, local visit costs, coordination with national ethics once someone files. What the CRO still owns:
- SRS authorization in El Salvador (DNM’s successor since August 2024) and the parallel CNEIS ethics packet.
- For sister rows on the same NCT: MINSA / CNBI in Panama and DIGEMAPS / CONABIOS in the Dominican Republic. Costa Rica’s national desk is a separate country file; we will not invent a regulator name that is not already on a bioaccess® country page in this intercept.
- Investigational import in each country — importer of record.
- ISO 14155 monitoring, EDC, SAE, TMF across four sites in four countries.
- 21 CFR 812.28 narrative so contralateral feasibility data is built for a later FDA conversation. Eligibility, not clearance. See OUS FIH and FDA IDE.
Site versus CRO
| Workstream | What López Beltrán / Centro Panamericano owns | What the CRO still owns |
|---|---|---|
| Cataract / accommodating IOL capability | OR, biometry, implanting ophthalmologists | Protocol feasibility, training, device accountability for AAL-FAIOL / BAL-FAIOL |
| Ethics | Local coordination | CNEIS packet; sister-country ethics where the other NCT rows sit |
| National authority | Not a hallway conversation | SRS in El Salvador; MINSA / DIGEMAPS on the other rows |
| Import | Receiving dock if contracted | Importer of record in each country |
| Quality | Clinic quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 package |
| Country optionality | One San Salvador row on a study now listed as active, not recruiting | Activation of Panama, Costa Rica, DR, or a Colombia alternative |
Sister sites on the same NCT — not this clinic
Do not merge López Beltrán with Clínica Quesada. Quesada is the facility on two Zeiss records (NCT05201027, NCT06192901) and the only listed site on Horizon Surgical Systems’ Polaris early-feasibility record (NCT06990074). Do not merge it with Instituto Espaillat Cabral in Santo Domingo — same Alcon protocol, different country and a different building, distinct from any Laser Center / Batlle GORE listing.
Optional public rows we are not giving their own slugs today: Clinica 20/20 in San José and Panama Eye Center in Panama City. The record no longer shows a per-site status for either. Panama Eye Center is the institution later MINIject papers identify as formerly Clínica de Ojos Orillac-Calvo; NCT03193736 (STAR-I MINIject, COMPLETED) lists that Panama City name. Those are public-record facts, not bioaccess® case studies.
SRS / CNEIS in one screen
Published on the El Salvador country page and not re-averaged here: 30–60 day parallel startup; dollarized economy; ~60% cost versus a U.S. program; 98.5% GCP on the published network figure; 21 CFR 812.28 eligibility with ISO 14155, SRS, and CNEIS. Two of the FIH names on that page now have a named El Salvador facility on ClinicalTrials.gov: Horizon’s Polaris at Clínica Quesada (NCT06990074) and Ocumedex’s Vizio at Centro de Diabetes Ocular El Dios de Israel (NCT06591117). Neither record lists López Beltrán. Avantec and Watershed stay country-level.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. An Alcon Central America NCT is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Frequently asked questions
Can I contract Centro Panamericano / López Beltrán directly?
You can try. A clinic can discuss interest and local cataract costs. It cannot become your SRS applicant, multi-country importer, ISO 14155 monitor, or 812.28 packager because Alcon listed it. The Alcon study is listed as active, not recruiting. Contract the CRO; let the CRO activate the site for your own protocol — or a sister country if that is the honest design.
Did bioaccess® run ILK345-E001?
No public bioaccess® page says so, and the NCT does not name a CRO. We will not invent that claim.
Is this first-in-human?
The record’s primary purpose field is DEVICE_FEASIBILITY. That is the honest label. It is an accommodating-IOL feasibility design in Central America, not a press-release we will inflate.
If I already have the clinic name, what does the CRO still do?
Regulatory-fit across the four NCT countries plus Colombia if needed; SRS / CNEIS and the other national packets; insurance; import; activation; ISO 14155 and the 812.28 narrative.
Does googling López Beltrán mean I should avoid the clinic?
No. Do not smear the site. The error is treating the site as the CRO.
Next step
Contact bioaccess® · First-in-Human CRO · El Salvador · CT.gov hub · Quesada · Espaillat Cabral · CRO in Colombia.
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