- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05052242
Evaluation of Ocular Biometry in PACD With Two Swept Source Optical Coherence Tomography Devices
Evaluation of Ocular Biometry in Primary Angle-closure Disease With Two Swept Source Optical Coherence Tomography Devices
Purpose: To investigate agreement between 2 swept source OCT biometers, IOL M.aster700 and Anterion, in various ocular biometry and intraocular lens (IOL) calculations of primary angle-closure disease (PACD).
Methods: This was a prospective study conducted in a tertiary eye care centre involving biometric measurements obtained with 2 devices in phakic eye with diagnosis of PACD. Mean difference and intraclass correlation coefficient (ICC) with confidence limits were assessed, and calculations of estimated residual refraction of the IOL were analysed using Barrett's formula.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Primary angle-closure disease (PACD) is the leading cause of blindness worldwide. PACD is an anatomic disorder, typically of relatively small eye with shallow anterior chamber depth (ACD), thick lens, shorter axial length (AL), small corneal curvature, and relatively anterior lens position. Pupillary block, plateau iris and phacomorphic mechanisms play major roles in the pathophysiology of the disease, and pupillary block is thought to be the most common causal mechanism.
For decades, phacoemulsification and intraocular lens implantation (PEI) has been proposed for initial management of PACD.4 PEI relieves pupillary block, deepening ACD and widening irido-corneal angle.
Biometry is essential in evaluating ocular dimensions and calculating IOL power in PACD, and ocular biometers have been evolving in recent years. Optical coherence tomography (OCT) includes partial coherence interferometry (PCI), and swept source OCT (SS-OCT) is in general use in clinical practice. The agreement of the calculations of these devices has been studied by many investigators; however, research into their agreement in PACD patients has been sparse so far. A newer SS-OCT, Anterion, is now available and its performance needs to be evaluated.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bangkok, Thailand, 10400
- Somporn Chantra
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Inclusion criteria were age > 40 years old
- phakic eye
- diagnosis of PACD, including primary angle-closure suspect (PACS), primary angle-closure (PAC) and primary angle-closure glaucoma (PACG) as classified by Foster et al
Exclusion Criteria:
- patients who had opaque optical media
- dense cataract
- anterior and/or posterior segment diseases such as advanced pterygium, diabetic retinopathy, or maculopathy
- Participants who had previous history of ocular trauma, ocular surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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one group compared two measurement methods
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2 swept source OCT biometers, IOL Master700 and Anterion
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Intraclass correlation coefficient of IOL power calculation
Tidsramme: 30 minutes per person
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agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in intraocular lens (IOL) calculations
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30 minutes per person
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Intraclass correlation coefficient of various ocular biometry
Tidsramme: 30 minutes per person
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agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in various ocular biometry( ACD, AL, LT, K1, K2, WTW)
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30 minutes per person
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Somporn Chantra, MD, Rajavithi Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Rajavithi Hospital (Annet stipend/finansieringsnummer: Rajavithi Hospital)
Plan for individuelle deltakerdata (IPD)
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