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

Severe Non-proliferative Diabetic Retinopathy Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01759121
• Other study ID #: S-PASCAL-PRP
• Secondary ID: ChiCTR-TRC-12002
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2012
• Last updated: October 12, 2017
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Pei-pei Wu
• Phone: 13602457876
• Email: ree04[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Severe Non-proliferative Diabetic Retinopathy

Intervention

Radiation:
• T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
• S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of best corrected visual acuity	best corrected visual acuity	1 year
Primary	the probability of vitreous haemorrhage		1 year
Secondary	Central Retinal Thickness		1 year
Secondary	foveal volume of macula		1 year
Secondary	amount of microaneurysms		1 year
Secondary	amount of bard exudate		1 year
Secondary	amount of retinal hemorrhage		1 year
Secondary	amount and area of IRMA		1 year
Secondary	amount of neovascularization		1 year
Secondary	change of ischemia area		1 year

External Links

•   a clinical study on subthreshold panretinal photocoagulation for proliferative diabetic retinopathy (PDR)