- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Bangkok, Thailand, 10400
- Somporn Chantra
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Intraclass correlation coefficient of IOL power calculation
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Somporn Chantra, MD, Rajavithi Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Rajavithi Hospital (Annat bidrag/finansieringsnummer: Rajavithi Hospital)
Plan för individuella deltagardata (IPD)
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