An interventional study of Wide-field optical coherence tomography (Optovue®) in Posterior Vitreous Detachment, sponsored by Khon Kaen University. Recruiting at 1 site in Thailand. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Khon Kaen University · Not applicable, Interventional, and Diagnostic
Intraocular surgery could induce vitreous degeneration and then abnormal posterior vitreous detachment (PVD) could occur including vitreoschisis and partial-thickness PVD. Vitreomacular interface (VMI) abnormalities such as epimacular membrane were observed following many intraocular surgeries. The incidence of peripheral break and epimacular membrane (EMM) after pneumatic retinopexy were 11.7% and 4-11%, respectively. Although multiple intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections induced PVD of 5.6%, but peripheral break was reported as only 0.67%. The incidence of rhegmatogenous retinal detachment (RRD) after phacoemulsification is gradually increased with time. The accumulative risk of RRD was increased from 0.27% at 1 year to 1.27% at 20 years after phacoemulsification.
The most common intraocular surgery is cataract surgery. From the literature review, many methods were used to detect the PVD after phacoemulsification. The former studies used indirect ophthalmoscopy and ocular ultrasound for diagnosis of PVD. The later studies used the optical coherence tomography (OCT) for PVD detection. The OCT device had higher effectiveness in evaluation of the posterior segment, and then it can detect post-phacoemulsification PVD more and early than previous studies. Ivastinovic et al demonstrated 59.2% of patients had PVD at 1 month after phacoemulsification, and increased up to 71.4% at 3 months.
Tsukahara et al introduced wide-field OCT-based PVD classification. The advance OCT device will be useful in detection of abnormal PVD and it's sequelae. If the risk factors of post-phacoemulsification PVD were explored, the prevention of abnormal PVD and VMI disorders could be done.
22 studies on the registry are indexed under Vitreous Detachment; 4 are open to participants now.
This study's planned enrollment of 92 is above the median of 43 across 14 interventional studies indexed under Vitreous Detachment.
Browse Vitreous Detachment studies →Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Withdrawal Criteria:
Wide-field optical coherence tomography was performed before the surgery, and then was done at 1, 3, 6 and 12 months following the phacoemulsification.
Device: Wide-field optical coherence tomography (Optovue®)
Merged 4 images for wide-filed OCT-based PVD classification, 2 vertical line images and 2 horizontal line images
The incidence of PVD after phacoemulsification
incidence of complete PVD
Time frame: 12 months
The incidence of VMI disorders
e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break
Time frame: 12 months
Plan to share: No
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