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Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT

13. mai 2026 oppdatert av: The New York Eye Surgery Center

Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated With Selective Laser Trabeculoplasty (SLT)

This study looks at a new laser treatment for people with high eye pressure or a type of glaucoma called open-angle glaucoma. All patients in the study have already had a similar laser treatment before (called SLT). In this study, everyone will receive the same treatment, called Direct Selective Laser Trabeculoplasty (Voyager™ DSLT). This device is approved by the FDA and will be used as directed. The goal is to understand how safe it is and how well it works in these patients.

Glaucoma is a major cause of permanent vision loss. A common treatment, called SLT, uses a laser to help lower pressure inside the eye. The newer treatment, DSLT, works in a similar way but does not touch the eye, which may make it quicker and more comfortable. DSLT has worked well in patients who have never had laser treatment before, but there is not much information about how well it works in people who have already had SLT.

The main goal of this study is to see how much the treatment lowers eye pressure after 6 months, compared to before treatment. To get accurate results, patients will stop their usual glaucoma eye drops for a short time before their eye pressure is measured. This helps show the true effect of the laser treatment.

The study will also look at other outcomes. These include how much eye pressure drops in percentage terms, how many patients have successful results, and whether patients can reduce the number of glaucoma medications they use. It will also track if any patients need additional glaucoma treatments later.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a prospective, single-arm, interventional study designed to evaluate the safety and effectiveness of direct selective laser trabeculoplasty (DSLT) using the Voyager™ DSLT system in patients with ocular hypertension or primary open-angle glaucoma who have previously undergone selective laser trabeculoplasty (SLT).

DSLT is a non-contact laser procedure that delivers energy to the trabecular meshwork through the limbus without requiring a gonioscopy lens. The procedure in this study is standardized, consisting of 120 laser applications delivered over 360 degrees using a 400 µm spot size and fixed energy of 1.8 mJ, without titration. Treatment is performed in a single eye per participant.

To minimize the confounding effects of topical ocular hypotensive medications, participants using such therapies at screening will undergo a protocol-defined washout period prior to baseline intraocular pressure (IOP) assessment and treatment. Additional washout is required prior to the 6-month follow-up assessment to allow for evaluation of treatment effect independent of adjunctive pharmacologic therapy.

IOP is measured using Goldmann applanation tonometry at defined study visits. During follow-up, initiation of IOP-lowering medications is permitted based on investigator-defined target IOP thresholds and clinical judgment. Criteria for treatment escalation and definitions of treatment failure, including the need for secondary glaucoma procedures or ocular surgery that may affect IOP, are specified in the protocol.

This study specifically evaluates the performance of DSLT in a population with prior SLT exposure, for whom the magnitude and durability of response to repeat or alternative laser therapy are not well established. The study is intended to generate data on IOP control and safety outcomes in this clinically relevant subgroup under standardized treatment and follow-up conditions.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • New York
      • The Bronx, New York, Forente stater, 10469
        • New York Eye Surgery Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • • Adult patients (18-80 years old), scheduled to undergo DSLT treatment in one eye.

    • Diagnosis of ocular hypertension (OHTN) or primary open angle glaucoma (POAG).
    • Previous history of selective laser trabeculoplasty (SLT) treatment. • Medication free or washed out IOP at time 0 ranging from ≥ 18 through 32 mm Hg.

Exclusion Criteria:

  • • Screened patients who were on IOP-lowering medications who did not successfully complete medication washout at the time of the procedure (time 0)

    • Previous glaucoma surgeries/interventions:

      • Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
      • Recent SLT failures (within 6 months of initial treatment).
    • Patients who have undergone cataract surgery within the prior 2 years.

    • Secondary glaucoma:

      o Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.

    • Other significant ocular conditions including advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function as deemed by the investigator.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: DSLT Treatment
Participants undergo direct selective laser trabeculoplasty (DSLT) in one eye using a fixed-energy protocol (120 shots, 400 µm spot size, 1.8 mJ, no titration). Intraocular pressure (IOP) is assessed at baseline (following medication washout) and during follow-up visits at 1 month, 3 months, and 6 months. A medication washout is required prior to baseline and the 6-month assessment. IOP-lowering medications may be introduced during follow-up based on investigator-defined thresholds.
Enhet: DSLT
Eligible participants will undergo the DSLT procedure: 120 shots, 400 µm spot size, 1.8mJ fixed energy (no titration) delivered at the limbus over 2.4 seconds

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Intraocular Pressure in Ocular Hypertension or Open-Angle Glaucoma Patients Previously Treated with Selective Laser Trabeculoplasty (SLT)
Tidsramme: baseline through 6 months post DSLT treatment
IOP measured using Goldmann applanation tonometry. Washed-out IOP assessed at baseline prior to DSLT and at 6 months post-treatment following protocol-defined medication washout.
baseline through 6 months post DSLT treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The New York Eye Surgery Center

Etterforskere

  • Hovedetterforsker: Nathan Radcliffe, M.D., New York Eye Surgery Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

3. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • NMR-15213

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (including intraocular pressure measurements and relevant study variables) will be made available to qualified researchers upon reasonable request

IPD-delingstidsramme

IPD will be available beginning 6 months following publication of the primary results and ending 5 years after publication.

Tilgangskriterier for IPD-deling

Data will be shared with researchers who provide a methodologically sound proposal. Requests should be directed to the study sponsor or principal investigator. A data use agreement may be required. Supporting documents, including the study protocol and statistical analysis plan, will also be made available.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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