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A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects

20. juli 2026 opdateret af: Berkeley Eye Center
This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Texas
      • Sugar Land, Texas, Forenede Stater, 77478
        • Rekruttering
        • Berkeley Eye Center - Sugar Land
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
  2. Ability to understand and sign an IRB/ethics committee-approved informed consent form.
  3. Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
  4. Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
  5. Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism <0.50 D.
  6. IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
  7. Ability to understand and complete study questionnaires.

Exclusion Criteria:

  1. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
  2. Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal degenerative disease (e.g., age-related macular degeneration), diabetic retinopathy, or other clinically significant retinal pathology.
  3. Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
  4. History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
  5. Prior ocular surgery (including corneal refractive surgery) in either eye.
  6. Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
  7. Participation in another clinical study (interventional) that could interfere with study results.
  8. Planned monovision/mini-monovision or desire for monovision targeting.
  9. Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment.
  10. Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments.
  11. Any active ocular infection or inflammation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Clareon TruPlus
Bilateral implantation with Clareon TruPlus
Aktiv komparator: Clareon monofocal
Bilateral implantation with Clareon monofocal

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Binocular photopic corrected distance visual acuity (CDVA) at 4 m
Tidsramme: 3 months postoperatively
3 months postoperatively

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual disturbances questionnaire
Tidsramme: 3 months postoperatively
Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.
3 months postoperatively
Satisfaction questionnaire
Tidsramme: 3 months postoperatively
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
3 months postoperatively
Binocular photopic distance corrected intermediate visual acuity (DCIVA) at 66 cm
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular photopic distance corrected near visual acuity (DCNVA) at 40 cm
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular mesopic corrected distance visual acuity (CDVA) at 4 m
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular photopic uncorrected distance visual acuity (UDVA) at 4 m
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular photopic uncorrected intermediate visual acuity (UIVA) at 66 cm
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular photopic uncorrected near visual acuity (UNVA) at 40 cm
Tidsramme: 3 months postoperatively
3 months postoperatively
Monocular mesopic corrected distance visual acuity (CDVA) at 4 m
Tidsramme: 3 months postoperatively
3 months postoperatively
Monocular mesopic distance corrected intermediate visual acuity (DCIVA) at 66 cm
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular mesopic best corrected distance contrast sensitivity without glare
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular mesopic best corrected distance contrast sensitivity with glare
Tidsramme: 3 months postoperatively
3 months postoperatively
Photopic low-contrast (25%) BCDVA at 4 m without glare
Tidsramme: 3 months postoperatively
3 months postoperatively
Binocular photopic distance-corrected defocus curve
Tidsramme: 3 months postoperatively
3 months postoperatively
Monocular distance-corrected defocus curve (dominant eye)
Tidsramme: 3 months postoperatively
3 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. juni 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 102811821

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Clareon TruPlus

Abonner