Posterior Vitreous DetachmentNCT04727398
The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification
A study testing Wide-field optical coherence tomography (Optovue®) in people with Posterior Vitreous Detachment, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posterior Vitreous Detachment
- What is being tested?
- Wide-field optical coherence tomography (Optovue®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteThailand
- Study dates
- 3 Sep 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Khon Kaen, 40002
Suthasinee Sinawat, MD, +66 815454594, ssuthasinee@kku.ac.th
Kwanchanok Chanthowong, MD
About this study
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.
Read the 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.
- Conditions
- Posterior Vitreous Detachment
- Being tested
- Wide-field optical coherence tomography (Optovue®)
- Keywords
- posterior vitreous detachment, phacoemulsification
- Medical subject headings
- Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wide-field optical coherence tomography (Optovue®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PVD after phacoemulsification
incidence of complete PVD
Measured: 12 months
Secondary outcomes (1)
The incidence of VMI disorders
e.g. Epimacular membrane, Vitreomacular traction, Peripheral retinal break
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start3 Sep 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Vitreous DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suthasinee Sinawat, Khon Kaen University
- Investigators
- Suthasinee Sinawat, MD, Principal investigator, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727398
- Sponsor's protocol ID
- HE631092
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Complete Posterior Vitreous Degeneration After Phacoemulsification
- ClinicalTrials.gov ID
- NCT04727398
- Acronym / sponsor ID
- HE631092
- Conditions
- Posterior Vitreous Detachment
- Keywords
- posterior vitreous detachment, phacoemulsification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract patients who was scheduled for phacoemulsification | Other | Device: Wide-field optical coherence tomography (Optovue®)Wide-field optical coherence tomography was performed before the surgery, and then was done at 1, 3, 6 and 12 months following the phacoemulsification. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Cataract patients who was scheduled for phacoemulsification |
Primary outcome
The incidence of PVD after phacoemulsification
Time frame: 12 months
incidence of complete PVD
1 secondary outcome
The incidence of VMI disorders
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suthasinee Sinawat, MD principal investigator
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide-field optical coherence tomography (Optovue®) in people with Posterior Vitreous Detachment, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suthasinee Sinawat, MD (+66 81 5454594, ssuthasinee@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PVD after phacoemulsification (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.