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

This study is currently recruiting participants.
Verified October 2017 by Jin Chen-jin, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759121
First Posted: January 2, 2013
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University
  Purpose
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.

Condition Intervention
Severe Non-proliferative Diabetic Retinopathy Radiation: T-PRP Radiation: S-PRP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Jin Chen-jin, Sun Yat-sen University:

Primary Outcome Measures:
  • change of best corrected visual acuity [ Time Frame: 1 year ]
    best corrected visual acuity

  • the probability of vitreous haemorrhage [ Time Frame: 1 year ]

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

Estimated Enrollment: 84
Actual Study Start Date: March 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
Radiation: T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
Other Name: 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 Name: Subthreshold PRP

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759121


Contacts
Contact: Pei-pei Wu 13602457876 ree04@126.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Peipei Wu    13602457876    ree04@126.com   
Principal Investigator: Chen-jin Jin         
Sub-Investigator: Peipei Wu         
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Jin Chen-jin, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01759121     History of Changes
Other Study ID Numbers: S-PASCAL-PRP
ChiCTR-TRC-12002735 ( Registry Identifier: Chinese Clinical Trial Registry )
First Submitted: December 18, 2012
First Posted: January 2, 2013
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Jin Chen-jin, Sun Yat-sen University:
severe non-proliferative diabetic retinopathy
subthreshold
panretinal photocoagulation
PASCAL
endpoint management

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases