The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

NCT ID: NCT04727398

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Posterior Vitreous Detachment

Study Design

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

Study Groups

Cataract patients who was scheduled for phacoemulsification

Wide-field optical coherence tomography was performed before the surgery, and then was done at 1, 3, 6 and 12 months following the phacoemulsification.

Group Type: OTHER

Wide-field optical coherence tomography (Optovue®)

Intervention Type: DEVICE

Merged 4 images for wide-filed OCT-based PVD classification, 2 vertical line images and 2 horizontal line images

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Cataract patients who was scheduled for phacoemulsification
• Age >50 years
• No complete PVD was detected by OCT
• Can be taken the wide-field OCT images
• Written informed consent

Exclusion Criteria

• Secondary cataract)
• History of ocular trauma or head trauma
• Systemic diseases that can cause the intraocular problems such as connective tissue disease
• History of other ocular diseases such as glaucoma, uveitis and vitreoretinal disorders
• History of intraocular laser treatment
• History of intraocular surgery such as intravitreal drug injection

Withdrawal Criteria:

• Intraoperative complications such as posterior capsular rupture and zonule dialysis
• Postoperative complications such as vitreous hemorrhage and postoperative endophthalmitis
• Undergo the intraocular surgery during the follow-up period
• Receiving the intraocular laser treatment during the follow-up period such as laser capsulotomy and panretinal photocoagulation
• Having the ocular trauma or head trauma during the follow-up period

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suthasinee Sinawat

Associate Professor

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

Site Status: RECRUITING

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

HE631092

Identifier Type: -

Identifier Source: org_study_id