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

Randomized, Parallel Controlled, Clinical-trial on 532nm Laser Partially Subthreshold Panretinal Photocoagulation With PASCAL Endpoint Management Function for Severe Non-proliferative Diabetic Retinopathy(NPDR)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01759121

Acronym

S-PRP

Enrollment

Registered

2013-01-02

Start date

2016-03-31

Completion date

2018-12-31

Last updated

2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Non-proliferative Diabetic Retinopathy

Keywords

severe non-proliferative diabetic retinopathy, subthreshold, panretinal photocoagulation, PASCAL, endpoint management

Brief summary

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.

Interventions

RADIATIONT-PRP

532nm-short pulse panretinal photocoagulation with PASCAL function

RADIATIONS-PRP

532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change of best corrected visual acuity	1 year	best corrected visual acuity
the probability of vitreous haemorrhage	1 year	—

Secondary

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

Countries

China

Contacts

Primary ContactPei-pei Wu

ree04@126.com13602457876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026