Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments and Lock-In: A Prospective Pilot Study
This observational pilot study will examine how a person's vision changes during the routine adjustment and finalization of a Light Adjustable Lens (LAL) after surgery. The study will focus on objective depth of focus, measured using iTrace wavefront analyzer, which describes how clearly a person can see at different distances. This is a non-invasive eye test that will be used alongside the standard lens adjustment process. This study will help researchers understand why some patients achieve unexpectedly good near or intermediate vision after LAL adjustments despite being targeted for emmetropia.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Rekruttering
- Lumea
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Kontakt:
- Jacqueline Sun
- Telefonnummer: 705-300-0741
- E-mail: Jsun@clarityeye.ca
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adults undergoing bilateral cataract surgery with LAL implantation as part of standard clinical care.
Beskrivelse
Inclusion Criteria:
- Adults ≥18 years of age.
- Scheduled to undergo bilateral cataract extraction with LAL implantation as standard-of-care.
- Able to provide written informed consent.
- Able to comply with study visits and required assessments throughout the LAL adjustment and lock-in sequence.
Exclusion Criteria:
- Presence of ocular comorbidities in either eye that may affect visual outcomes or wavefront measurements, including but not limited to glaucoma, age-related macular degeneration, diabetic retinopathy, corneal disease, amblyopia, or prior refractive surgery.
- Intraoperative complications affecting IOL positioning, centration, or stability.
- Inability to obtain reliable iTrace measurements due to inadequate fixation or poor measurement quality.
- Participation in another interventional ophthalmic clinical study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Monocular Depth of Focus
Tidsramme: Baseline, prior to each UV adjustment, and prior to the first lock-in.
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Change in objective monocular depth of focus throughout the LAL UV adjustment and lock-in sequence, measured using the iTrace wavefront aberrometry system. Objective monocular depth of focus will be quantified using the VSOTF-based DOF profile and reported as the DOF range (D) at each timepoint. |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Uncorrected Distance Visual Acuity
Tidsramme: Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
UDVA monocular and binocular |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
|
Uncorrected Near Visual Acuity
Tidsramme: Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
UNVA monocular and binocular |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
|
Best Corrected Distance Visual Acuity
Tidsramme: Baseline, prior to each UV adjustment, and prior to the first lock-in.
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BCDVA monocular |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
|
Manifest Refraction
Tidsramme: Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Manifest refraction (sphere, cylinder, axis) |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
iTrace-derived angle kappa
Tidsramme: Baseline, prior to each UV adjustment, and prior to the first lock-in.
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Angle Kappa from the iTrace will be taken at each step |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CEI-LAL-DOF-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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