The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.
navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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 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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGBest corrected visual acuity
Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Time frame: 12 months
Central Retinal Thickness
Central Retinal Thickness will be performed by optical coherence tomography(OCT)
Time frame: 12 months
10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
Time frame: 12 months
treatment time
treatment time is time from laser treatment beginning to end
Time frame: 1 hour
Participants pain intensity
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) .
Time frame: 1 hour
Number of laser spots within macular fovea
Number of laser spots within macular fovea will measured by foundus photograph
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.