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Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR (S-PRP)

Primary Purpose

Severe Non-proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
T-PRP
S-PRP
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Non-proliferative Diabetic Retinopathy focused on measuring severe non-proliferative diabetic retinopathy, subthreshold, panretinal photocoagulation, PASCAL, endpoint management

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

T-PRP

S-PRP

Arm Description

532nm-short pulse panretinal photocoagulation with PASCAL function

532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function

Outcomes

Primary Outcome Measures

change of best corrected visual acuity
best corrected visual acuity
the probability of vitreous haemorrhage

Secondary Outcome Measures

Central Retinal Thickness
foveal volume of macula
amount of microaneurysms
amount of bard exudate
amount of retinal hemorrhage
amount and area of IRMA
amount of neovascularization
change of ischemia area

Full Information

First Posted
December 18, 2012
Last Updated
October 12, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01759121
Brief Title
Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR
Acronym
S-PRP
Official Title
Randomized, Parallel Controlled, Clinical-trial on 532nm Laser Partially Subthreshold Panretinal Photocoagulation With PASCAL Endpoint Management Function for Severe Non-proliferative Diabetic Retinopathy(NPDR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Non-proliferative Diabetic Retinopathy
Keywords
severe non-proliferative diabetic retinopathy, subthreshold, panretinal photocoagulation, PASCAL, endpoint management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T-PRP
Arm Type
Active Comparator
Arm Description
532nm-short pulse panretinal photocoagulation with PASCAL function
Arm Title
S-PRP
Arm Type
Experimental
Arm Description
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
Intervention Type
Radiation
Intervention Name(s)
T-PRP
Other Intervention Name(s)
Traditional-PRP
Intervention Description
532nm-short pulse panretinal photocoagulation with PASCAL function
Intervention Type
Radiation
Intervention Name(s)
S-PRP
Other Intervention Name(s)
Subthreshold PRP
Intervention Description
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
Primary Outcome Measure Information:
Title
change of best corrected visual acuity
Description
best corrected visual acuity
Time Frame
1 year
Title
the probability of vitreous haemorrhage
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Central Retinal Thickness
Time Frame
1 year
Title
foveal volume of macula
Time Frame
1 year
Title
amount of microaneurysms
Time Frame
1 year
Title
amount of bard exudate
Time Frame
1 year
Title
amount of retinal hemorrhage
Time Frame
1 year
Title
amount and area of IRMA
Time Frame
1 year
Title
amount of neovascularization
Time Frame
1 year
Title
change of ischemia area
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-pei Wu
Phone
13602457876
Email
ree04@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-jin Jin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pei-pei Wu
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peipei Wu
Phone
13602457876
Email
ree04@126.com
First Name & Middle Initial & Last Name & Degree
Chen-jin Jin
First Name & Middle Initial & Last Name & Degree
Peipei Wu

12. IPD Sharing Statement

Citations:
PubMed Identifier
36070046
Citation
Zhao H, Zhou L, Lai K, Yu M, Huang C, Xu F, Li C, Lu L, Jin C. Comparison of functional changes of retina after subthreshold and threshold pan-retinal photocoagulation in severe non-proliferative diabetic retinopathy. Lasers Med Sci. 2022 Dec;37(9):3561-3569. doi: 10.1007/s10103-022-03635-8. Epub 2022 Sep 7.
Results Reference
derived
Links:
URL
http://www.nature.com/eye/journal/v22/n5/full/6702725a.html
Description
a clinical study on subthreshold panretinal photocoagulation for proliferative diabetic retinopathy (PDR)

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

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