Safety and Effectiveness Study of 532nm Laser Subthreshold Panretinal Photocoagulation for Severe NPDR
NCT ID: NCT01759121
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2016-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
Interventions
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T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Jin Chen-jin
Dr
Principal Investigators
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Chen-jin Jin
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Pei-pei Wu
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Peipei Wu
Role: primary
References
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Li Z, Lu T, Zhou L, Huang C, Zhao H, Liang J, Li C, Cong Q, Lan Y, Jin C. Retinal and Choroidal Alterations in Diabetic Retinopathy Treatment using Subthreshold Panretinal Photocoagulation with Endpoint Management Algorithm: A Secondary Analysis of a Randomized Clinical Trial. Ophthalmol Ther. 2023 Aug;12(4):1867-1880. doi: 10.1007/s40123-023-00713-0. Epub 2023 Apr 30.
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.
Related Links
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a clinical study on subthreshold panretinal photocoagulation for proliferative diabetic retinopathy (PDR)
Other Identifiers
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ChiCTR-TRC-12002735
Identifier Type: REGISTRY
Identifier Source: secondary_id
S-PASCAL-PRP
Identifier Type: -
Identifier Source: org_study_id