- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07790185
Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK
24. august 2026 oppdatert av: Vance Thompson Vision
To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
Studieoversikt
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kayla Karpuk, OD
- Telefonnummer: 605-361-3937
- E-post: kayla.karpuk@vancethompsonvision.com
Studiesteder
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57108
- Rekruttering
- Vance Thompson Vision
-
Ta kontakt med:
- Kayla Karpuk, OD
- Telefonnummer: 605-361-3937
- E-post: kayla.karpuk@vancethompsonvision.com
-
-
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
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Subjects ages 18 to 45 years old.
- Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery or stability as determined by the investigator.
- Myopia with or without astigmatism and MRSE within the range of indications for wavelight plus (myopia up to -8.00D, astigmatism up to -3.00D, S.E. more than -1.00 and up to -9.00D)
- Best corrected distance visual acuity (BCDVA) of 20/20 or better (≥83 letters) in each eye.
- Subjects who have elected to undergo bilateral LASIK targeted for emmetropia.
- Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
- Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- Mesopic pupil size ≥4.5mm
- Less than 0.75D spherical equivalent differences between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
- Subjects who regularly drive at night and expect to continue night driving throughout the duration of the study, as determined by investigator assessment
Exclusion Criteria:
- Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or have another condition with associated fluctuation of hormones that could lead to refractive changes.
- Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
- Previous corneal ocular surgery
- History of evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma or glaucoma suspect.
- Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
- Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator.
- Subjects who, in the judgment of the Investigator, present any emotional, physiological, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- Patients with a calculated residual stromal depth <250 um
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: WaveLight Plus
|
comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Establish non-inferiority of the post-operative uncorrected mesopic distance visual acuity MVA (UC-MVA, monocular) at 6 months to the pre-operative Best Spectacle-Corrected MVA (BSC-MVA, monocular), assessed in logMAR units
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Patient reported outcome of overall satisfaction with vision, measured using the Patient Reported Outcomes with LASIK - Satisfaction Survey (#1 of PROWL-SS, 0-100)
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Satisfaction with night vision (modified based on #1 of PROWL-SS, 0 - 100) at baseline and 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Difficulty driving at night (from PROWL, Top-2-box) at baseline and 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Frequency of starbursts or halo that bother you (PROWL, Top-2-box) at baseline and 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Mesopic contrast sensitivity measured with and without glare (binocular) at baseline and 6-month post-op+
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Uncorrected Distance Visual Acuity under photopic conditions at 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Refractive predictability, percentage of eyes within ±0.25D, ±0.50D of target MRSE at 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Other night vision questions and VND-Q (item 1-4, Top-2-box of each) at baseline and 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
Other domain scores of PROWL-SS (glare, halo, starbursts)
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
|
BOSA tear film analysis at baseline and 6-month post-op
Tidsramme: Baseline compared to 6 month post operative visit
|
Baseline compared to 6 month post operative visit
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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 (Faktiske)
20. april 2026
Primær fullføring (Antatt)
1. september 2027
Studiet fullført (Antatt)
1. november 2027
Datoer for studieregistrering
Først innsendt
24. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 101390595
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
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