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

This study is currently recruiting participants.
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
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
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014