The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

Posterior Vitreous Detachment Clinical Trial

Official title:

The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727398
• Other study ID #: HE631092
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Khon Kaen University
• Contact: Suthasinee Sinawat, MD
• Phone: +66 81 5454594
• Email: ssuthasinee[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posterior Vitreous Detachment
• Vitreous Detachment

Intervention

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

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of PVD after phacoemulsification	incidence of complete PVD	12 months
Secondary	The incidence of VMI disorders	e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break	12 months