Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.

NCT04726267 | Unknown DMC

• 1 other identifier: HE631456
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Vitreous Detachment

Keywords

posterior vitreous detachment; trabeculectomy; vitreomacular interface

Outcome Measures

Primary Outcomes (1)

• Incidence of PVD

  complete PVD

  12 months

Secondary Outcomes (1)

• The incidence of VMI abnormalities

  12 months

Study Arms (1)

Glaucoma patients who was scheduled for trabeculectomy

OTHER

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.

Device: Wide-field optical coherence tomography

Interventions

Wide-field optical coherence tomography DEVICE

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

Glaucoma patients who was scheduled for trabeculectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Vitreous Detachment

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Suthasinee Sinawat, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthasinee Sinawat, MD

CONTACT

+66 81 5454594; ssuthasinee@kku.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KKU Eye Center, Department of Ophthalmology

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: July 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)