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Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular

Sponsor
Bo Jia (Other)
Overall Status
Completed
CT.gov ID
NCT06133660
Collaborator
(none)
21
Enrollment
1
Location
28
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pars plana vitrectomy

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
Actual Study Start Date :
Oct 30, 2020
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
PPV（pars plana vitrectomy） group

Procedure: pars plana vitrectomy
pars plana vitrectomy and Silicone oil removal to distinguish subjects
Other Names:
  • Silicone oil removal

    		•
    Silicone oil removal group

    Procedure: pars plana vitrectomy
    pars plana vitrectomy and Silicone oil removal to distinguish subjects
    Other Names:
  • Silicone oil removal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. degree of lens opacity [1 year]

    2. lens thickness [1 year]

    Secondary Outcome Measures

    1. anterior chamber depth [1 year]

    2. axial length [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Hospital of Jilin University Changchun China

    Sponsors and Collaborators

    • Bo Jia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bo Jia, M.D., Second Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT06133660
    Other Study ID Numbers:
    • second hospital of JilinU
    First Posted:
    Nov 15, 2023
    Last Update Posted:
    Nov 15, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bo Jia, M.D., Second Hospital of Jilin University
    aqueous tamponade
    cataract
    lens thickness
    axial length
    pars plana vitrectomy
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Nov 15, 2023