Clinical trial NCT01759121: Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Non-proliferative Diabetic Retinopathy
Keywords: severe non-proliferative diabetic retinopathy
subthreshold
panretinal photocoagulation
PASCAL
endpoint management
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 84
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: change of best corrected visual acuity
timeFrame: 1 year
measure: the probability of vitreous haemorrhage
timeFrame: 1 year
Secondary outcomes:
measure: Central Retinal Thickness
timeFrame: 1 year
measure: foveal volume of macula
timeFrame: 1 year
measure: amount of microaneurysms
timeFrame: 1 year
measure: amount of bard exudate
timeFrame: 1 year
measure: amount of retinal hemorrhage
timeFrame: 1 year
measure: amount and area of IRMA
timeFrame: 1 year
measure: amount of neovascularization
timeFrame: 1 year
measure: change of ischemia area
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chen-jin Jin
role: STUDY_DIRECTOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Pei-pei Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao H, Zhou L, Lai K, Yu M, Huang C, Xu F, Li C, Lu L, Jin C. Comparison of functional changes of retina after subthreshold and threshold pan-retinal photocoagulation in severe non-proliferative diabetic retinopathy. Lasers Med Sci. 2022 Dec;37(9):3561-3569. doi: 10.1007/s10103-022-03635-8. Epub 2022 Sep 7.