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

Not Applicable

• Conditions: Severe Non-proliferative Diabetic Retinopathy
• Interventions: Radiation: T-PRP; Radiation: S-PRP

• Registration Number: NCT01759121
• Lead Sponsor: Sun Yat-sen University

Brief 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.

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 Timeline

• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2013-01-01
• Study First Posted: 2013-01-02
• Study Start: 2016-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T-PRP	T-PRP	532nm-short pulse panretinal photocoagulation with PASCAL function
S-PRP	S-PRP	532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function

Primary Outcome Measures

Name	Time	Method
the probability of vitreous haemorrhage	1 year
change of best corrected visual acuity	1 year	best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
amount of bard exudate	1 year
amount of retinal hemorrhage	1 year
amount and area of IRMA	1 year
foveal volume of macula	1 year
amount of neovascularization	1 year
Central Retinal Thickness	1 year
amount of microaneurysms	1 year
change of ischemia area	1 year

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China