Figures cited from ClinicalTrials.gov NCT05557058, ICH GCP registry mirrors, published bioaccess® Dominican Republic pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the clinic, investigator, and trial those sources support. We do not claim W. L. Gore and Associates as a bioaccess® client.
If you searched Laser Center Santo Domingo clinical trial, Juan Batlle GORE glaucoma, Dominican Republic first-in-human ophthalmic, or go direct to the site in Santo Domingo, you are following a clinic name that is genuinely in the public file. Laser Center in Santo Domingo is a real ophthalmic research site. It is not the operator of the DIGEMAPS file.
bioaccess®’s position is simple and it is not adversarial: Laser Center is the site. The First-in-Human CRO still owns DIGEMAPS, CONABIOS-overseen ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package plus the option to add Colombia, Panama, Mexico, or El Salvador if the Dominican Republic is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A ClinicalTrials.gov row does not become a CRO.
This page is the intercept for that search. It does not clone clinical trials in the Dominican Republic or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.
Why the clinic name wins the search — and why that is not a CRO
Device registries write the implant, the city, the site, and sometimes the PI. They rarely write the CRO. The GORE Glaucoma Drainage Implant early feasibility study is the clean public example for Santo Domingo.
NCT05557058, retrieved 23 August 2026: official title is a prospective, single-center, early feasibility clinical study designed to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in subjects with primary open-angle glaucoma. Lead sponsor: W. L. Gore and Associates. Status: active, not recruiting. Start date 14 September 2022. Estimated enrollment 30. Design: interventional, randomized parallel arms for High and Low device configurations plus a non-randomized Modified configuration. Primary effectiveness listed on the registry: proportion of treated eyes with at least a 20 percent decrease in mean diurnal IOP at 6 months while maintaining the same or fewer hypotensive medications as at baseline. Single listed location: Laser Center, Santo Domingo, Dominican Republic.
ICH GCP registry mirrors of the same NCT list the principal investigator as Juan F. Batlle Pichardo, M.D., Laser Center. That is useful public information about a site-named Dominican ophthalmic EFS. It is not a bioaccess® case study. As of this writing, bioaccess® does not list W. L. Gore as a client on our published pages, and this article will not invent that relationship.
That listing is how a sponsor finds Laser Center without finding the operator. Winning the query means answering it as the CRO that already publishes Dominican Republic first-in-human device operations and still runs the rest of the Latin American platform.
Laser Center is a site. The CRO is the operator.
A Santo Domingo ophthalmic center can provide the OR, imaging, and an investigator who is already named on a public early-feasibility glaucoma implant listing. That is necessary. It is not sufficient for a first-in-human or early-feasibility 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 with a service such as Dr. Batlle Pichardo 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:
- DIGEMAPS. The Ministry of Public Health, through the Directorate General of Medicines, Food and Health Products, is the national authority. A hallway conversation with a surgeon is not that file.
- CONABIOS-overseen ethics. Institutional REC review and CONABIOS-level review are country-system work, already described on the Dominican Republic page.
- Investigational import. Ethics letter, investigator brochure, and an importation permit — end-to-end work, not a PI email.
- Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Santo Domingo-only number here.
- 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. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance.
- Multi-country optionality. If Dominican enrollment or the indication later needs Colombia or Panama, a single-clinic MSA will not stretch.
Going direct to Laser Center is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.
How DIGEMAPS and CONABIOS sit next to the clinic
Use the country page for the full pathway. Facts a sponsor searching this clinic needs on one screen, already published on clinical-trials-dominican-republic:
The Ministry of Public Health through DIGEMAPS is the national regulatory authority. Ethics oversight is coordinated by CONABIOS, which supervises Research Ethics Committees. Institutional REC review averages about 30 days. CONABIOS-level review averages about 45 days (up to 120 depending on complexity). Protocols follow the Declaration of Helsinki and CIOMS guidelines. bioaccess® prepares dossiers and coordinates with DIGEMAPS through start-up. Foreign data is discussed with FDA under 21 CFR 812.28 as eligibility, not a promise of clearance, when the study is run under ISO 14155 with proper authorization and ethics approval.
We will not invent a Laser Center-only day-count. Ask for a protocol-specific calendar. A surgeon email is not a DIGEMAPS approval.
What the GORE public file actually supports — and what it does not
- Device: GORE Glaucoma Drainage Implant, several configurations (registry).
- Site: Laser Center, Santo Domingo, Dominican Republic (NCT05557058 locations).
- PI on registry mirrors: Juan F. Batlle Pichardo, M.D., Laser Center.
- Design: prospective, single-center, early feasibility; estimated n=30; start 14 September 2022; active, not recruiting on the 23 August 2026 snapshot.
- Not claimed here: that the NCT named bioaccess®; that Laser Center is the only ophthalmic site in the Dominican Republic; that we have GORE outcomes; that Centro Laser marketing copy is the same as a first-in-human quality system.
What the CRO still does after you have a clinic name
- Regulatory-fit, not tourism. The Dominican Republic is a sourced ophthalmic EFS geography. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS 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® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Santo Domingo site.
Do not smear the clinic
Laser Center and Dr. Batlle Pichardo are serious ophthalmic resources. This page is not a critique of the site. A public EFS listing is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.
Colombia is still on the map
A Santo Domingo 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 | Laser Center / the site | bioaccess® / the CRO |
|---|---|---|
| Procedure | OR, imaging, glaucoma service, PI | Protocol fit, training, device accountability |
| Ethics | Institutional REC calendar | Packet, ICF, IB, CONABIOS coordination |
| National authority | Not the permit holder by being listed on an NCT | DIGEMAPS |
| 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 Santo Domingo | Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform |
Frequently asked questions
Can I contract Laser Center Santo Domingo directly?
You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT05557058, become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate Laser Center as the site if it is the right site for your protocol.
Who is the PI on the GORE GDI listing?
Juan F. Batlle Pichardo, M.D., Laser Center, as stated on ICH GCP mirrors of NCT05557058. That fact does not make the PI your CRO.
What does the CRO still do if the clinic is already identified?
Regulatory-fit and country choice; the DIGEMAPS and CONABIOS 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 or Panama if Santo Domingo is not enough. The clinic still does the procedure.
Is an early feasibility study the same as a commercial first implant in LATAM?
No. NCT05557058 is an investigational early feasibility program. A commercial first implant is launch activity. Do not mix the two when you brief a board.
Next step
If the search that brought you here was Laser Center or Juan Batlle, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: CODET Vision Tijuana, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country: Dominican Republic, Colombia, Panama.
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