Safety and Effectiveness Study of 532nm Laser Subthreshol... | NCT01759121

Studies
Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR

NCT01759121

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Oct 13, 2017Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Severe Non-proliferative Diabetic Retinopathy

Interventions

T-PRP
S-PRP

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

ID	Type	Description	Link
ChiCTR-TRC-12002735	Registry Identifier	Chinese Clinical Trial Registry

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Jan 1, 2013

First Posted Date

Jan 2, 2013Estimated

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

Oct 12, 2017

Last Update Posted Date

Oct 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Detailed Description

This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy : (1)To evaluate therapeutic effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy; (2)To compare side effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function on retina with traditional visible endpoint panretinal photocoagulation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T-PRP	Active Comparator	532nm-short pulse panretinal photocoagulation with PASCAL function	Radiation: T-PRP
S-PRP	Experimental	532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function	Radiation: S-PRP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T-PRP	Radiation	532nm-short pulse panretinal photocoagulation with PASCAL function	T-PRP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of best corrected visual acuity	best corrected visual acuity	1 year
the probability of vitreous haemorrhage		1 year

Secondary Outcomes

Measure	Description	Time Frame
Central Retinal Thickness		1 year
foveal volume of macula		1 year
amount of microaneurysms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of severe non-proliferative diabetic retinopathy
Age:45-80 years
Best corrected visual acuity(BCVA) ≥20/100,Myopia≤-6 degree(-6D)
No photocoagulation (PRP) before this clinical trial and no major ocular surgery (including cataract extraction, or any other intraocular surgery) within 3 months
Ability and willingness to provide informed consent

Exclusion Criteria:

Participate in other clinical trials within 3 months
Severe refractive media turbidity; Unable to accept laser treatment such as nystagmus, etc
Medically or mentally unstable(including cardiovascular disorders, cerebrovascular diseases,liver and kidney disease,hematological disorder and psychosis
Conditions that in the opinion of the investigator would interfere trial results or increase risk
Conditions that in the opinion of the investigator would preclude participation in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pei-pei Wu	Contact	13602457876		ree04@126.com

Overall Officials

Name	Affiliation	Role
Chen-jin Jin	Zhongshan Ophthalmic Center, Sun Yat-sen University	Study Director
Pei-pei Wu	Zhongshan Ophthalmic Center, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510060	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37120774	Derived	Li Z, Lu T, Zhou L, Huang C, Zhao H, Liang J, Li C, Cong Q, Lan Y, Jin C. Retinal and Choroidal Alterations in Diabetic Retinopathy Treatment using Subthreshold Panretinal Photocoagulation with Endpoint Management Algorithm: A Secondary Analysis of a Randomized Clinical Trial. Ophthalmol Ther. 2023 Aug;12(4):1867-1880. doi: 10.1007/s40123-023-00713-0. Epub 2023 Apr 30.
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