Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT03641144|
Recruitment Status : Unknown
Verified August 2018 by Jin Chen-jin, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Device: Navigation laser Device: Traditional laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema：A Prospective, Randomized, Paralleled Clinical Trial|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Navigation laser
Navigation laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Device: 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.
Other Name: Navigation laser photocoagulation treatment
Active Comparator: Traditional laser
Traditional laser photocoagulation treatment to the macular area of retinal thickening with a focal pattern and/or grid pattern
Device: 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 Name: Traditional laser photocoagulation treatment
- Best corrected visual acuity [ Time Frame: 12 months ]Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
- Central Retinal Thickness [ Time Frame: 12 months ]Central Retinal Thickness will be performed by optical coherence tomography(OCT)
- 10°retinal sensitivity [ Time Frame: 12 months ]Retinal sensitivity will be measured by microperimetry
- treatment time [ Time Frame: 1 hour ]treatment time is time from laser treatment beginning to end
- Participants pain intensity [ Time Frame: 1 hour ]Participants pain intensity will be immediately measured by Visual Analogue Scale/Score （VAS）after treatment.The VAS is a straight horizontal line of fixed length（100 mm）. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (0) to the right (100).The patient marks on the line the point that participants feel represents their perception of their current pain intensity.the VAS score is determined by measuring the distance (mm) on the 100mm line between the "0" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) .
- Number of laser spots within macular fovea [ Time Frame: 1 month ]Number of laser spots within macular fovea will measured by foundus photograph
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641144
|Contact: Yajun Gong, Bacheloremail@example.com|
|Contact: Chenjin Jin, Ph.Dfirstname.lastname@example.org|
|Study Chair:||Chenjin Jin, Ph.D||State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University|