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

Sun Yat-sen University

Status: Unknown

Conditions: Severe Non-proliferative Diabetic Retinopathy

Treatments: Radiation: T-PRP; Radiation: S-PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT01759121

ChiCTR-TRC-12002735 (Registry Identifier)

S-PASCAL-PRP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

T-PRP

Active Comparator group

Description:

532nm-short pulse panretinal photocoagulation with PASCAL function

Treatment:

Radiation: T-PRP

S-PRP

Experimental group

Description:

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

Treatment:

Radiation: S-PRP