Aqueous TamponadeNCT06133660
Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
An observational study of Aqueous Tamponade and Cataract, run by Bo Jia at 1 site in China.
Trial summary
To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state of the lens and related parameters of the eye, and whether the changes of the above parameters are correlated with age, gender, diabetes or not, etc., so as to provide references for the diagnosis and treatment of related… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Aqueous Tamponade, Cataract
- What is being tested?
- pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 1 Mar 2023
- Phase
- Observational
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases, or underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes
Who may be able to join
- ① Patients undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases;
- Patients who underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes; ③ Intraoperative BSS was used for fill the vitreous cavity; ④ Before treatment, inform the patient that the clinical data may be used in clinical research, and the patient and his family are informed and sign the informed consent.
Who cannot join
- ① The operation eye was intraocular lens or cataract extraction during operation; ② Suspensory ligament relaxation or rupture, ciliary body detachment or transaction, lens dislocation, endophthalmitis, traumatic cataract;
- intraoperative lens injury; ④ patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state of the lens and related parameters of the eye, and whether the changes of the above parameters are correlated with age, gender, diabetes or not, etc., so as to provide references for the diagnosis and treatment of related diseases and scientific research.
- Conditions
- Aqueous Tamponade, Cataract
- Being tested
- pars plana vitrectomy
- Keywords
- aqueous tamponade, cataract, lens thickness, axial length, pars plana vitrectomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomyProcedure or surgery
Also called Silicone oil removal
pars plana vitrectomy and Silicone oil removal to distinguish subjects
| Study group | Role | What they receive |
|---|---|---|
| PPV（pars plana vitrectomy） group | Not described Receives: Procedure: pars plana vitrectomy | |
| Silicone oil removal group | Not described Receives: Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of lens opacity
Measured: 1 year
lens thickness
Measured: 1 year
Secondary outcomes (2)
anterior chamber depth
Measured: 1 year
axial length
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start30 Oct 2020
- Primary completion1 Oct 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aqueous TamponadeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo Jia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Jia, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133660
- Sponsor's protocol ID
- second hospital of JilinU
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
- ClinicalTrials.gov ID
- NCT06133660
- Acronym / sponsor ID
- second hospital of JilinU
- Conditions
- Aqueous Tamponade, Cataract
- Keywords
- aqueous tamponade, cataract, lens thickness, axial length, pars plana vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bo JiaUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Nov 2023 (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.
To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state of the lens and related parameters of the eye, and whether the changes of the above parameters are correlated with age, gender, diabetes or not, etc., so as to provide references for the diagnosis and treatment of related diseases and scientific research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPV（pars plana vitrectomy） group | – | Procedure: pars plana vitrectomy |
| Silicone oil removal group | – | Procedure: pars plana vitrectomy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases, or underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes
Key inclusion criteria (2 listed)
- ① Patients undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases;
Key exclusion criteria (2 listed)
- ① The operation eye was intraocular lens or cataract extraction during operation; ② Suspensory ligament relaxation or rupture, ciliary body detachment or transaction, lens dislocation, endophthalmitis, traumatic cataract;
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 |
|---|---|---|
| pars plana vitrectomyAlso: Silicone oil removalpars plana vitrectomy and Silicone oil removal to distinguish subjects | Procedure or surgery | PPV（pars plana vitrectomy） group, Silicone oil removal group |
Primary outcome
degree of lens opacity
Time frame: 1 year
lens thickness
Time frame: 1 year
2 secondary outcomes
anterior chamber depth
Time frame: 1 year
axial length
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aqueous Tamponade and Cataract, run by Bo Jia at 1 site in China.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Nov 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
degree of lens opacity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 15 Nov 2023.