Influence of Intravitreal Aqueous Tamponade on Lens Statu... | NCT06133660

Studies
Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular

NCT06133660

Sponsor

Bo Jia

Status

Completed

Last Update Posted

Nov 15, 2023Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Aqueous Tamponade
Cataract

Interventions

pars plana vitrectomy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2020Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Nov 10, 2023

First Submission Date that Met QC Criteria

Nov 10, 2023

First Posted Date

Nov 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2023

Last Update Posted Date

Nov 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PPV（pars plana vitrectomy） group			Procedure: pars plana vitrectomy
Silicone oil removal group			Procedure: pars plana vitrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pars plana vitrectomy	Procedure	pars plana vitrectomy and Silicone oil removal to distinguish subjects	PPV（pars plana vitrectomy） group Silicone oil removal group

Measure	Description	Time Frame
degree of lens opacity		1 year
lens thickness		1 year

Measure	Description	Time Frame
anterior chamber depth		1 year
axial length		1 year

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases