Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.

NCT ID: NCT04726267

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-06-30

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.

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.

Conditions

Posterior Vitreous Detachment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Glaucoma patients who was scheduled for trabeculectomy

Wide-field OCT was performed 1-2 weeks before the trabeculectomy. The OCT was done postoperatively at 1 month, 3 months, 6 months and 12 months after surgery.

Group Type: OTHER

Wide-field optical coherence tomography

Intervention Type: DEVICE

Merged 4 images of wide-field optical coherence tomography, 2 images of vertical scan and 2 images of horizontal scan.

Interventions

Wide-field optical coherence tomography

Merged 4 images of wide-field optical coherence tomography, 2 images of vertical scan and 2 images of horizontal scan.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Primary open angle glaucoma or primary angle closure glaucoma
• Age 18-65 years
• Could be taken the wide-field OCT images
• Written informed consent

Exclusion Criteria

• History of intraocular inflammation or infection
• History of ocular trauma or head trauma
• History of intraocular surgery such as intravitreal drug injection and cataract surgery
• History of vitreoretinal diseases such as diabetic retinopathy, retinal vascular occlusion and age-related macular degeneration
• History of laser treatment including laser capsulotomy and retinal photocoagulation
• High myopia; spherical equivalence >4 diopters
• Complete PVD was detected before the enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suthasinee Sinawat

KKU Eye Center, Department of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthasinee Sinawat, MD

Role: PRINCIPAL_INVESTIGATOR

KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Locations

Khon Kaen University

Khon Kaen, , Thailand

Countries

Thailand

Central Contacts

Suthasinee Sinawat, MD

Role: CONTACT

ssuthasinee@kku.ac.th

+66 81 5454594

Facility Contacts

Suthasinee Sinawat, MD

Role: primary

ssuthasinee@kku.ac.th

+66 815454594

Other Identifiers

HE631456

Identifier Type: -

Identifier Source: org_study_id