Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular

November 10, 2023 updated by: Bo Jia
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changchun, China
        • The Second Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
degree of lens opacity
Time Frame: 1 year
1 year
lens thickness
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
anterior chamber depth
Time Frame: 1 year
1 year
axial length
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bo Jia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2020

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • second hospital of JilinU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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