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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. (see Contacts and Locations)
Verified December 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01759121
First received: December 18, 2012
Last updated: January 1, 2013
Last verified: December 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Sun Yat-sen University:

Primary Outcome Measures:
  • change of best corrected visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    best corrected visual acuity

  • the probability of vitreous haemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central Retinal Thickness [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • foveal volume of macula [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • amount of microaneurysms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • amount of bard exudate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • amount of retinal hemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • amount and area of IRMA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • amount of neovascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • change of ischemia area [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: December 18, 2012
Last Updated: January 1, 2013
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014