The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

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.

Study Overview

• Status: Recruiting
• Conditions: Posterior Vitreous Detachment
• Intervention / Treatment: Device: Wide-field optical coherence tomography (Optovue®)

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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suthasinee Sinawat, MD; Phone Number: +66 81 5454594; Email: ssuthasinee@kku.ac.th

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Khon Kaen University
    • Contact: Suthasinee Sinawat, MD; Phone Number: +66 815454594; Email: ssuthasinee@kku.ac.th
    • Sub-Investigator: Kwanchanok Chanthowong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of PVD after phacoemulsification	incidence of complete PVD	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of VMI disorders	e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break	12 months

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Suthasinee Sinawat, MD, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: phacoemulsification; posterior vitreous detachment
• Additional Relevant MeSH Terms: Eye Diseases; Vitreous Detachment
• Other Study ID Numbers: HE631092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No