Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT04726267
Status:
UNKNOWN
Last Update Posted:
2021-06-30
First Post:
2021-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
Sponsor:
Khon Kaen University
Organization:
Study Overview
Official Title:
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intraocular surgery could induce vitreous degeneration and posterior vitreous detachment (PVD). Vitreomacular interface (VMI) abnormalities usually are caused by abnormal PVD, vitreoschisis and partial-thickness PVD. Furthermore, the PVD could induce the peripheral break. 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 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, 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. 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, 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. 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.
Detailed Description:
Trabeculectomy is one of the intraocular surgery. Although the volume of intraocular fluid use during the trabeculectomy was much less than used during phacoemulsification, trabeculectomy also could induce the PVD and it's sequelae such as VMI abnormalities. Because the baseline visual acuity of glaucoma patients who were indicated for trabeculectomy usually quite poor, so the sequelae of PVD can cause more visual loss. The incidence of PVD after trabeculectomy has never been published before and nowadays no standard guideline for retinal examination or screening after surgery. Furthermore, Tsukahara et al introduced wide-field OCT-based PVD classification. The new OCT device with higher technology will be useful in PVD detection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: