Figures cited from the live ClinicalTrials.gov record NCT07147192 and the published bioaccess® Dominican Republic and El Salvador country pages, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. Instituto Espaillat Cabral is distinct from Laser Center / Batlle GORE listings. 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 Instituto Espaillat Cabral clinical trial, Espaillat Cabral IOL, Alcon accommodating IOL Santo Domingo, or “go direct to Espaillat,” you followed a facility name ClinicalTrials.gov published. Instituto Espaillat Cabral in Santo Domingo is a real ophthalmic site. It is not the operator of the DIGEMAPS file.
bioaccess®’s position is simple and it is not adversarial: Espaillat Cabral is the site. The First-in-Human CRO still owns DIGEMAPS / CONABIOS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus El Salvador, Panama, Costa Rica, or Colombia if one Santo Domingo room is not the design. Sponsors who skip the CRO and email the institute still have to rebuild that stack.
This page does not clone clinical trials in the Dominican Republic. That page stays the country system. This page answers the site-named query. It is not a Laser Center intercept.
What NCT07147192 actually says for Santo Domingo
NCT07147192 — Feasibility Study of an Accommodating IOL Design. Sponsor: Alcon Research. Organization study ID: ILK345-E001. Overall status: RECRUITING. The Espaillat row is NOT_YET_RECRUITING. Actual start 3 December 2025; estimated completion January 2028; estimated enrollment 85; device-feasibility, contralateral AAL-FAIOL vs BAL-FAIOL after phacoemulsification, 14–35 days between eyes, ~1 year follow-up, optional laser adjustment of the AAL lens. Conducted in Central America per the brief summary (the location table also includes the Dominican Republic). Primary outcome: cumulative ocular adverse events including secondary surgical interventions. Ages 22+. Central contact: Alcon Call Center. Study director: Clinical Trial Lead, Surgical, Alcon Research, LLC. No local PI is named on the Espaillat row.
Sister rows on the same live record: Clinica 20/20, San José, Costa Rica (RECRUITING); Centro Panamericano de Ojos / Clinica Lopez Beltran, San Salvador (NOT_YET_RECRUITING); Panama Eye Center, Panama City (RECRUITING). See the López Beltrán intercept for the San Salvador twin. Panama Eye Center is publicly identified in MINIject literature as formerly Clínica de Ojos Orillac-Calvo; NCT03193736 lists that Panama City name for STAR-I (COMPLETED). Those are public-record facts, not bioaccess® case studies.
Distinct from Laser Center
Santo Domingo has more than one ophthalmic brand in device-trial search results. This intercept is only Instituto Espaillat Cabral as written on NCT07147192. We searched CMS for a Laser Center slug before writing; it was not occupied as a dedicated intercept. We will not merge Espaillat Cabral with Laser Center, CODET, or a Batlle GORE study. If a later wave publishes those buildings, they will get their own pages.
The institute is a site. The CRO is the operator.
Espaillat Cabral can provide cataract rooms and surgeons who can, when activated, implant an investigational accommodating IOL. That is necessary. It is not sufficient for a four-country feasibility file a U.S. board expects to survive FDA review.
- DIGEMAPS. The Ministry of Public Health’s Directorate General of Medicines, Food and Health Products is the national authority on the published DR country page. A clinic letter is not that dossier.
- CONABIOS / REC. Published clocks: institutional REC ~30 days; CONABIOS-level ~45 days, up to 120 depending on complexity. Someone still has to write the packet.
- Investigational import into the Dominican Republic — importer of record.
- ISO 14155 monitoring that also covers sister rows in El Salvador, Panama, and Costa Rica.
- 21 CFR 812.28 — eligibility, not clearance. OUS FIH and FDA IDE.
Site versus CRO
| Workstream | What Espaillat Cabral typically owns | What the CRO still owns |
|---|---|---|
| Cataract / accommodating IOL capability | OR, biometry, implanting ophthalmologists | Protocol feasibility, training, AAL-FAIOL / BAL-FAIOL accountability |
| Ethics | Institutional REC coordination | CONABIOS-overseen packet, ICF, IB alignment |
| National authority | Not a hallway conversation | DIGEMAPS |
| Import | Receiving dock if contracted | Importer of record |
| Quality | Clinic quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative |
| Country optionality | One Santo Domingo row, currently not yet recruiting | Panama, El Salvador, Costa Rica, Colombia if the design needs them |
DIGEMAPS in one screen
Published on clinical-trials-dominican-republic: DIGEMAPS as national authority; CONABIOS-overseen RECs; Helsinki / CIOMS; 21 CFR 812.28 eligibility with ISO 14155; nearshore U.S. flights; experience-based ~30% lower program cost versus a U.S./EU baseline on that page. Those are country figures, not an Espaillat quote.
El Salvador’s published 30–60 day parallel SRS / CNEIS clock and Panama’s published MINSA / CNBI pathway sit on their country pages if the same Alcon design is the reason you are also looking at San Salvador or Panama City.
Four NCT rows, one operator problem
ILK345-E001 is already a multi-country design. Costa Rica and Panama are recruiting on the live record; Santo Domingo and San Salvador are not. Emailing Espaillat Cabral does not activate Panama Eye Center, Clinica 20/20, or López Beltrán, and it does not file DIGEMAPS, SRS, or MINSA. If the honest next case is in a country that is already recruiting, that is a CRO sequencing decision — not a reason to smear the Dominican site for being listed as not yet recruiting. The row is a fact. The file is still the CRO’s.
What “not yet recruiting” is not
NOT_YET_RECRUITING on a Santo Domingo row is not a quality judgment and not a reason to attack the institute. It means Alcon’s public file has not flipped that location to recruiting. A CRO still has to file DIGEMAPS, clear CONABIOS-overseen ethics, import the lenses, train the team, and monitor to ISO 14155 before that flip is operationally real. Treating the NCT status as the entire startup plan is how boards lose a quarter.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Santo Domingo NCT row 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 Instituto Espaillat Cabral directly?
You can try. The institute can discuss interest and local cataract costs. It cannot become your DIGEMAPS applicant, importer, insurer, ISO 14155 monitor, or 812.28 packager because Alcon listed it. The Santo Domingo row is still not yet recruiting. Contract the CRO; let the CRO activate the site or a sister country already recruiting.
Did bioaccess® run ILK345-E001 at Espaillat?
No public bioaccess® page says so. We will not invent that claim.
Is this the Laser Center / Batlle study?
No. This page is only Instituto Espaillat Cabral on NCT07147192. Do not merge the buildings.
Is this first-in-human?
The record’s primary purpose is DEVICE_FEASIBILITY. That is the honest label.
If I already have the institute name, what does the CRO still do?
Regulatory-fit across the NCT countries plus Colombia; DIGEMAPS / CONABIOS; insurance; import; activation; ISO 14155; 812.28.
Does googling Espaillat mean I should avoid the institute?
No. Do not smear the site. The error is treating the site as the CRO.
Next step
Contact bioaccess® · First-in-Human CRO · Dominican Republic · CT.gov hub · López Beltrán · Quesada · CRO in Colombia.