Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
NCT ID: NCT03641144
Last Updated: 2018-08-21
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
80 participants
INTERVENTIONAL
2018-06-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Navigation laser
Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Navigation laser
Navigation laser device is a scanning slit-based instrument.before treatment the surgeon plan laser spots on the screen based on image(infrared, colour, fluorescein angiography)and then apply automated patterns and single spots as appropriate.the device will automatically carry out the plan.
Traditional laser
Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Traditional laser
Traditional laser is a slitlamp based instrument.Surgeon operate traditional laer device while watching Participant's image(infrared, colour, fluorescein angiography) and then manually aim at and trigger laser.
Interventions
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Navigation laser
Navigation laser device is a scanning slit-based instrument.before treatment the surgeon plan laser spots on the screen based on image(infrared, colour, fluorescein angiography)and then apply automated patterns and single spots as appropriate.the device will automatically carry out the plan.
Traditional laser
Traditional laser is a slitlamp based instrument.Surgeon operate traditional laer device while watching Participant's image(infrared, colour, fluorescein angiography) and then manually aim at and trigger laser.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed as diabetic retinopathy with Mild macular edema
* BCVA≥0.5
* No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
Exclusion Criteria
* Accompanied with severe hypertension（BP≥180/110mmHg）
* Taking part in other clinical trial within 3 months
* Planning panretinal photocoagulation(PRP) within 3 months
* Performed cataract surgery in the last 3 months
* Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
* Accompanied with severe opacity of refractive media that maybe impact therapy and observation
* Accompanied with nystagmus
* Accompanied with some history that maybe interfere with result or increase the risk of patients
18 Years
80 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Jin Chen-jin
Professor，Dr
Principal Investigators
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Chenjin Jin, Ph.D
Role: STUDY_CHAIR
State Key Laboratory of Ophthalmology, 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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Other Identifiers
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NLPD-ZOC
Identifier Type: -
Identifier Source: org_study_id
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