Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
1 other identifier
observational
21
1 country
1
Brief 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 diseases and scientific research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 10, 2023
CompletedFirst Posted
Study publicly available on registry
November 15, 2023
CompletedNovember 15, 2023
November 1, 2023
1.9 years
November 10, 2023
November 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
degree of lens opacity
1 year
lens thickness
1 year
Secondary Outcomes (2)
anterior chamber depth
1 year
axial length
1 year
Study Arms (2)
PPV（pars plana vitrectomy） group
Silicone oil removal group
Interventions
pars plana vitrectomy and Silicone oil removal to distinguish subjects
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bo Jialead
Study Sites (1)
The Second Hospital of Jilin University
Changchun, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
November 10, 2023
First Posted
November 15, 2023
Study Start
October 30, 2020
Primary Completion
October 1, 2022
Study Completion
March 1, 2023
Last Updated
November 15, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share