Back to resultsThe Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification
Primary Purpose
Posterior Vitreous Detachment
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Wide-field optical coherence tomography (Optovue®)
Sponsored by
About this trial
This is an interventional diagnostic trial for Posterior Vitreous Detachment focused on measuring posterior vitreous detachment, phacoemulsification
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
Sites / Locations
- Khon Kaen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cataract patients who was scheduled for phacoemulsification
Arm Description
Wide-field optical coherence tomography was performed before the surgery, and then was done at 1, 3, 6 and 12 months following the phacoemulsification.
Outcomes
Primary Outcome Measures
The incidence of PVD after phacoemulsification
incidence of complete PVD
Secondary Outcome Measures
The incidence of VMI disorders
e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04727398
Brief Title
The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification
Official Title
The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Vitreous Detachment
Keywords
posterior vitreous detachment, phacoemulsification
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract patients who was scheduled for phacoemulsification
Arm Type
Other
Arm Description
Wide-field optical coherence tomography was performed before the surgery, and then was done at 1, 3, 6 and 12 months following the phacoemulsification.
Intervention Type
Device
Intervention Name(s)
Wide-field optical coherence tomography (Optovue®)
Intervention Description
Merged 4 images for wide-filed OCT-based PVD classification, 2 vertical line images and 2 horizontal line images
Primary Outcome Measure Information:
Title
The incidence of PVD after phacoemulsification
Description
incidence of complete PVD
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The incidence of VMI disorders
Description
e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suthasinee Sinawat, MD
Phone
+66 81 5454594
Email
ssuthasinee@kku.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, MD
Organizational Affiliation
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, MD
Phone
+66 815454594
Email
ssuthasinee@kku.ac.th
First Name & Middle Initial & Last Name & Degree
Kwanchanok Chanthowong, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification
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