The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

NCT04727398 | Unknown

• 1 other identifier: HE631092
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Vitreous Detachment

Keywords

posterior vitreous detachment; phacoemulsification

Outcome Measures

Primary Outcomes (1)

• The incidence of PVD after phacoemulsification

  incidence of complete PVD

  12 months

Secondary Outcomes (1)

• The incidence of VMI disorders

  12 months

Study Arms (1)

Cataract patients who was scheduled for phacoemulsification

OTHER

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®)

Interventions

Wide-field optical coherence tomography (Optovue®) DEVICE

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

Cataract patients who was scheduled for phacoemulsification

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

RECRUITING

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: Associate Professor

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 27, 2021
• Study Start: September 3, 2021
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)