The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

Sponsor

Khon Kaen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04727398

Collaborator

(none)

Enrollment

Location

Arm

21.8

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posterior Vitreous Detachment	Device: Wide-field optical coherence tomography (Optovue®)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification

Anticipated Study Start Date :

Sep 3, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The incidence of PVD after phacoemulsification [12 months]
incidence of complete PVD

Secondary Outcome Measures

The incidence of VMI disorders [12 months]
e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khon Kaen University	Khon Kaen		Thailand	40002

Sponsors and Collaborators

Khon Kaen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suthasinee Sinawat, Associate Professor, Khon Kaen University

ClinicalTrials.gov Identifier:

NCT04727398

Other Study ID Numbers:

HE631092

First Posted:

Jan 27, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suthasinee Sinawat, Associate Professor, Khon Kaen University

posterior vitreous detachment

phacoemulsification

Additional relevant MeSH terms:

Vitreous Detachment

Study Results

No Results Posted as of Sep 5, 2021