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

October 12, 2017 updated by: Jin Chen-jin, Sun Yat-sen University

Randomized, Parallel Controlled, Clinical-trial on 532nm Laser Partially Subthreshold Panretinal Photocoagulation With PASCAL Endpoint Management Function for Severe Non-proliferative Diabetic Retinopathy(NPDR)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Chen-jin Jin
        • Sub-Investigator:
          • Peipei Wu

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

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
Radiation: T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
Other Names:
  • Traditional-PRP
EXPERIMENTAL: S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
Radiation: S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
Other Names:
  • Subthreshold PRP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Central Retinal Thickness
Time Frame: 1 year
1 year
foveal volume of macula
Time Frame: 1 year
1 year
amount of microaneurysms
Time Frame: 1 year
1 year
amount of bard exudate
Time Frame: 1 year
1 year
amount of retinal hemorrhage
Time Frame: 1 year
1 year
amount and area of IRMA
Time Frame: 1 year
1 year
amount of neovascularization
Time Frame: 1 year
1 year
change of ischemia area
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Chen-jin Jin, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Principal Investigator: Pei-pei Wu, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

January 1, 2013

First Posted (ESTIMATE)

January 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-PASCAL-PRP
  • ChiCTR-TRC-12002735 (REGISTRY: Chinese Clinical Trial Registry)

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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