ASOCT Changes After Vitrectomy and Silicone Oil InjectionNCT05599854
Short-term Anterior Segment Changes After Pars Plana Vitrectomy (PPV) and Silicone Oil (SO) Tamponade, Anterior Segment OCT (AS-OCT) Study.
A study testing vitrectomy and silicone oil injection in people with ASOCT Changes After Vitrectomy and Silicone Oil Injection, run by Assiut University.
Trial summary
The purpose of our study is to utilize AS-OCT to analyze the anterior segment morphological changes in the early postoperative period of patients who will undergo PPV with silicone oil injection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ASOCT Changes After Vitrectomy and Silicone Oil Injection
- What is being tested?
- vitrectomy and silicone oil injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from different vitreo-retinal disorders (rhegmatogenous retinal detachment, diabetic vitreous hemorrhage, diabetic tractional retinal detachment) with either preserved crystalline lens or previous cataract surgery (at least 3 months prior to PPV) will be recruited
Who cannot join
- Patient with previous history of ocular trauma, co-existing glaucoma, co-existing anterior uveitis, complicated cataract surgery, IOL-related complications, previous vitreo-retinal surgery, visually significant cataract (necessitating combined phacoemulsification with PPV and SO) and significant corneal opacity will be excluded. If any significant post-PPV complication develops, patient will be excluded from the study.
About this study
The purpose of our study is to utilize AS-OCT to analyze the anterior segment morphological changes in the early postoperative period of patients who will undergo PPV with silicone oil injection.
Read the detailed description
- Type of the study: A prospective comparative study.
- Study Setting: Assiut university hospital.
- Study subjects:
- Inclusion criteria: Patients suffering from different vitreo-retinal disorders (rhegmatogenous retinal detachment, diabetic vitreous hemorrhage, diabetic tractional retinal detachment) with either preserved crystalline lens or previous cataract surgery (at least 3 months prior to PPV) will be recruited
- Exclusion criteria: Patient with previous history of ocular trauma, co-existing glaucoma, co-existing anterior uveitis, complicated cataract surgery, IOL-related complications, previous vitreo-retinal surgery, visually significant cataract (necessitating combined phacoemulsification with PPV and SO) and significant corneal opacity will be excluded. If any significant post-PPV complication develops, patient will be excluded from the study.
- Sample Size Calculation: Thirty eyes (30 patients) will undergo PPV with SO tamponade and AS-OCT analysis prior to surgery and 1 week post-operatively to achieve study power of 80% with 0.05 significance. 4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): All participants underwent best-corrected visual acuity (BCVA) by Snellen's chart, Slit lamp assessment of the anterior segment, dilated fundus examination, intra-ocular pressure (IOP) measurement by calibrated Goldmann Applanation Tonometer (GAT). Baseline Ophthalmic ultrasound and Axial length measurement will be obtained. Anterior segment OCT (AS-OCT) protocol All eyes will be examined by AS-OCT (Nidek RS-3000 Advance, Tokyo, Japan) 1-2 days prior to vitreo-retinal surgery and one week after surgery by single experienced physician. Poor fixation or poor image signal (less than 3/10) will exclude the patient from the study. Anterior segment OCT (AS-OCT) parameters The following anterior segment parameters will be evaluated; central and peripheral anterior chamber depth (cACD, pACD), anterior chamber angle (ACA) and central corneal thickness (CCT). 5 -Research outcome measures: <!-- -->
- Primary (main): Mean change in central anterior chamber depth after PPV with SO tamponade.
- Secondary (subsidiary):
Mean change in peripheral anterior chamber depth, mean change in anterior chamber angle and mean change anterior chamber angle entry area.
- Being tested
- vitrectomy and silicone oil injection
- Keywords
- ASOCT, vitrectomy, silicone oil injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy and silicone oil injectionProcedure or surgery
Also called PPV and SOI
Parsplana vitrectomy and silicone oil injection
What is being measured
The primary outcome is the main question the study is designed to answer.
central anterior chamber depth
Mean change in central anterior chamber depth after PPV with SO tamponade.
Measured: 1 week
Secondary outcomes (3)
peripheral anterior chamber depth
Mean change in peripheral anterior chamber depth
Measured: 1 week
anterior chamber angle
mean change in anterior chamber angle
Measured: 1 week
anterior chamber angle entry area
mean change anterior chamber angle entry area
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASOCT Changes After Vitrectomy and Silicone Oil InjectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alaa Ezzat Abdelmoneim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599854
- Sponsor's protocol ID
- ASOCT changes after vitrectomy
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Anterior Segment Changes After Pars Plana Vitrectomy (PPV) and Silicone Oil (SO) Tamponade, Anterior Segment OCT (AS-OCT) Study.
- ClinicalTrials.gov ID
- NCT05599854
- Acronym / sponsor ID
- ASOCT changes after vitrectomy
- Keywords
- ASOCT, vitrectomy, silicone oil injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 Oct 2022 (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.
The purpose of our study is to utilize AS-OCT to analyze the anterior segment morphological changes in the early postoperative period of patients who will undergo PPV with silicone oil injection.
Detailed description
- Type of the study: A prospective comparative study.
- Study Setting: Assiut university hospital.
- Study subjects:
- Inclusion criteria: Patients suffering from different vitreo-retinal disorders (rhegmatogenous retinal detachment, diabetic vitreous hemorrhage, diabetic tractional retinal detachment) with either preserved crystalline lens or previous cataract surgery (at least 3 months prior to PPV) will be recruited
- Exclusion criteria: Patient with previous history of ocular trauma, co-existing glaucoma, co-existing anterior uveitis, complicated cataract surgery, IOL-related complications, previous vitreo-retinal surgery, visually significant cataract (necessitating combined phacoemulsification with PPV and SO) and significant corneal opacity will be excluded. If any significant post-PPV complication develops, patient will be excluded from the study.
- Sample Size Calculation: Thirty eyes (30 patients) will undergo PPV with SO tamponade and AS-OCT analysis prior to surgery and 1 week post-operatively to achieve study power of 80% with 0.05 significance. 4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): All participants underwent best-corrected visual acuity (BCVA) by Snellen's chart, Slit lamp assessment of the anterior segment, dilated fundus examination, intra-ocular pressure (IOP) measurement by calibrated Goldmann Applanation Tonometer (GAT). Baseline Ophthalmic ultrasound and Axial length measurement will be obtained. Anterior segment OCT (AS-OCT) protocol All eyes will be examined by AS-OCT (Nidek RS-3000 Advance, Tokyo, Japan) 1-2 days prior to vitreo-retinal surgery and one week after surgery by single experienced physician. Poor fixation or poor image signal (less than 3/10) will exclude the patient from the study. Anterior segment OCT (AS-OCT) parameters The following anterior segment parameters will be evaluated; central and peripheral anterior chamber depth (cACD, pACD), anterior chamber angle (ACA) and central corneal thickness (CCT). 5 -Research outcome measures: <!-- -->
- Primary (main): Mean change in central anterior chamber depth after PPV with SO tamponade.
- Secondary (subsidiary):
Mean change in peripheral anterior chamber depth, mean change in anterior chamber angle and mean change anterior chamber angle entry area.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from different vitreo-retinal disorders (rhegmatogenous retinal detachment, diabetic vitreous hemorrhage, diabetic tractional retinal detachment) with either preserved crystalline lens or previous cataract surgery (at least 3 months prior to PPV) will be recruited
Key exclusion criteria (1 listed)
- Patient with previous history of ocular trauma, co-existing glaucoma, co-existing anterior uveitis, complicated cataract surgery, IOL-related complications, previous vitreo-retinal surgery, visually significant cataract (necessitating combined phacoemulsification with PPV and SO) and significant corneal opacity will be excluded. If any significant post-PPV complication develops, patient will be excluded from the study.
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 |
|---|---|---|
| vitrectomy and silicone oil injectionAlso: PPV and SOIParsplana vitrectomy and silicone oil injection | Procedure or surgery | – |
Primary outcome
central anterior chamber depth
Time frame: 1 week
Mean change in central anterior chamber depth after PPV with SO tamponade.
3 secondary outcomes
peripheral anterior chamber depth
Time frame: 1 week
anterior chamber angle
Time frame: 1 week
anterior chamber angle entry area
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy and silicone oil injection in people with ASOCT Changes After Vitrectomy and Silicone Oil Injection, run by Assiut University.
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 1 inclusion and 1 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central anterior chamber depth (time frame: 1 week). 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 31 Oct 2022; AzTrials last refreshed its copy on 31 Oct 2026.